Category Archives: Psychedelics

Tune In: Field Trip has eight ketamine-assisted therapy clinics across North America.

Seth Wilson, a 41-year-old sommelier in Chicago, has been dealing with depression and anxiety since he was 13 years old. Wilson learned to live with his panic attacks until his mother passed away and they gradually got worse. He had been on some kind of antidepressant or anti-anxiety medication for over a decade, but he wasnt getting the help he needed. One day last spring, he went to a Field Trip Health clinic overlooking Lake Michigan, put on eyeshades, headphones, leaned back in a comfy zero-gravity leather chair and got an injection of the dissociative anesthetic ketamine. Within seconds he was blasted to the cosmos and entered the event horizon of a black hole.

Instead of being overcome with fear and panic, he was washed over by waves of awe and a feeling that theres something beyond life as we know it. I sound like a doting hippie, but I realized that nothing else matters except for love and gratitude, says Wilson.

Since seeking ketamine-assisted therapy, which includes six infusions, followed by talk therapy sessions, he has cut his dose of anti-anxiety medication in half. Before undergoing ketamine therapy, he had wanted to do therapy with other psychedelics like psilocybin, the active ingredient in magic mushrooms, or LSD. Even though biotech startups are racing to develop medicines based on psilocybin, MDMA and other psychedelic molecules and get them approved by the U.S. Food and Drug Administration, these substances are still illegal in the U.S. But ketamine has a big advantage over other psychedelicsits legal.

Thanks to its legal status and the psychedelic renaissance underway, ketamine-assisted therapy has reached the mainstream. And companies like Field Trip Health, Novamind, Nushama, Mindbloom and others are stepping on the gas and expanding locations and services to patients across the country.

While psilocybin, MDMA and LSD grab most of the headlines for the promising clinical results as potential treatments for depression, post-traumatic stress disorder and other mental health issues, ketamine is able to cash in on the growing interest in psychedelics.

Ketamine also has another advantage over other psychedelics: its short-acting. One of the biggest hurdles in widespread treatment of psychedelic-assisted therapy for drugs like psilocybin, LSD and MDMA is the duration of the experience, which can range from 4 to 12 hours. But for ketamine, a patient can be in and out of one of these swanky clinics in two hours. (Some companies are trying to remove the psychedelic experience altogether, while others are modifying psychedelics molecules to make the trip shorter.)

Ronan Levy, the CEO of Field Trip Health, which has eight clinics across the U.S. and Canada, says hes seeing an increase in the number of patient visits across every location. The company says it will expand to 20 locations by the end of 2021 and scale to 75 clinics by 2024. The demand for psychedelic-assisted therapy is growing, and while FDA-approved psilocybin or MDMA is still years away, ketamine is already here.

When people realize that there is a legal option available right now that can be provided with medical supervision and professional therapy, it becomes a really appealing option, says Levy. Its the most easily accessible, legal option, which is leading to the boom around ketamine right now.

Field Trip is not the only one benefiting from how ketamine has gone mainstream.

Novamind, which owns a Utah-based chain of clinics under the name Cedar Psychiatry that offers ketamine-assisted therapy, is trying to keep up with the demand. Earlier this year, the company said it had a two-week wait time at each of its clinics. Last year, it saw 20,000 patients and says by the end of the year Novamind is on pace to see 65,000 patients, a 225% increase.

Yaron Conforti, the CEO of Novamind, says ketamine is enjoying a moment, especially as mental health awareness has increased during the pandemic and more people are looking for different types of treatment.

Ketamine is having its time, says Conforti. Its happening now.

Ketamine has largely lost its stigma as a party drug and a horse tranquilizer. But it took time, even though ketamine has been an FDA-approved anesthetic for decades used on the battlefield, in pediatrics and yes, by veterinarians. Much of the growing interest in ketamine is thanks to the FDA approving Spravato, which is a nasal spray that contains a ketamine derivative called esketamine, in 2019. Spravato, which is made by Johnson & JohnsonsJanssen, is approved to treat adults with treatment-resistant depression and depressive symptoms in adults with major depressive disorder with suicidal thoughts or behavior.

Craig Chepke, a psychiatrist with his own practice in Huntersville, North Carolina, says the FDA approving Spravato, and the fact that insurance companies are now covering the drug, has helped usher in the mainstreaming of ketamine treatments. When Spravato was first approved in 2019, hed only see about two patients a week. Hes now seeing close to ten patients a day.

I dont think anyone can ignore it at this point, says Chepke. If it's not on the mind of every psychiatrist who treats treatment-resistant depression, it darn better be because it helps. It doesnt help everybody, but it does help a lot of these patients who really have nothing else left and who have exhausted almost every avenue of treatment.

But the best part of ketamine-assisted therapy, Chepke says, is more of an abstract notion.

Its the spark of hope, says Chepke. I always said the most important thing a doctor can give a patient is not a prescriptionit's hope. And for many people, some of these psychedelic substances are giving them hope.

Another reason why ketamine-assisted therapy is getting more and more popular is because of positive patient outcomes.

Day to day, the majority of our clients walk in depressed and walk out feeling considerably better, if not completely undepressed, says Ben Medrano, a psychiatrist whos the medical director at Field Trip. Its commonplace for us.

But ketamine is just the first step for companies like Field Trip.Itwill eventually expand to offer other psychedelic drugs if they become approved by the FDA or allowed under state programs. (Oregon is in the process of launching a psilocybin-assisted therapy program.) Levy says the best way to think about Field Trip is a psychedelic therapy platform that will offer patients a menu of psychedelic compounds to be used in therapy.

Our clinical infrastructure will be molecule agnostic, says Levy. Different molecules will serve different patients; different indications and we intend to support any psychedelic-assisted therapies. It could be MDMA, psilocybin or our own novel molecules, and if LSD gets approved for something, fantastic.

Promising studies out ofJohns Hopkins,Imperial College London,New York University, theMultidisciplinary Association for Psychedelic Studies(MAPS) and other institutions have found therapeutic potential of drugs like psilocybin and MDMA for various conditions, including depression, end-of-life anxiety, post-traumatic stress disorder, obsessive-compulsive disorder and nicotine and alcohol dependence.

Field Trips big plan is to bring its own hallucinogenic compound to market. It is developing a psychedelic molecule that targets the 5HT-2A receptor in the brain, the same one psilocybin targets, and plans to pursue FDA approval. The compound, which the company has named FT-104 for the time being, packs a trip thats only two hours long, or half the time an experience with magic mushrooms lasts. The company plans to launch phase 1 clinical trials early next year.

During Wilsons last ketamine session, he set an intention to see his late mother. Once the ketamine took hold, his mother took him to experience her birth and showed him the afterlife. He says the experience helped him deal with the trauma of his mothers death, but also helped him manage his anxiety and depression by showing him there is something beyond the physical world.

Were all searching for the ineffable and its so deeply personal, he says. I think the word God can be triggering for people, but its about this trust and faith that there is something bigger and grander than ourselves. And that this physical world doesnt matter and all our problems dont matterthere is something greater.

Go here to read the rest:

Why Ketamine-Assisted Therapy Has Gone Mainstream - Forbes

There is increasing awareness (in part due to COVID-19) that mental ill-health can affect anyone under certain circumstances, and that mental ill-health can be prevalent in society.

Within this context, it may be an opportune time to analyse promising and/or effective therapies that have not yet entered mainstream therapy for mental ill-health, likley because of regulatory impediments. One such class of therapy would be psychedelic therapy.

On 25 August 2021, Mind Medicine Australia (MMA) released a media alert urgently calling for the Australian Federal and State governments to enable psychedelic-assisted therapies to be used to treat severely ill patients who desperately need safe and effective treatments. MMA noted that current treatments achieve remission rates for depression of around 30-35% and for PTSD only around 5%. In contrast, MMA noted that psychedelic-assisted therapy with psilocybin and 3,4-methylenedioxymethamphetamine (MDMA) achieved remission rates for depression and PTSD of between 60 and 80% after just 2 to 3 treatments in combination with a short course of psychotherapy. In Australia, psilocybin and MDMA are classified by the Therapeutic Goods Administration (TGA) in Schedule 9 as Prohibited Substances.

Despite this contrast in therapeutic efficacy, MMA highlighted what it referred to as an absurd situation preventing such therapy. Specifically, psychiatrists in Australia can obtain approval from the TGA to use substances such as these in medically-controlled environments as part of psychotherapy, but are unable to do so because the States and Territories of Australia (except Victoria) do not have a permit system allowing access to Schedule 9 substances.

In July 2020, MMA applied to have certain psychedelics reclassified from Schedule 9 to Schedule 8 as Controlled Drugs. In a further media release dated 1 October 2021, MMA announced that the TGA had moved one step closer to rescheduling MDMA and psilocybin in Australia upon release of the TGAs Independent Expert Panel on MDMA and psilocybin on 30 September 2021. The Panel searched for randomised controlled trials (RCTs) of MDMA and psilocybin with either inactive or active controls, reviewed the outcomes, and conducted a meta-analysis on the studies. The Panel demonstrated statistically significant differences of the two psychedelic agents between both inactive and active treatments and noted that both agents were well-tolerated. The Panel concluded that:

MDMA and psilocybin may show promise in highly selected populations but only where these medicines are administered in closely clinically supervised settings and with intensive professional support.

The Panel's report will be considered by the Advisory Committee of Medicines Scheduling (ACMS) on 3 November 2021, with a final decision anticipated to be published the first week of December 2021.

If psychedelics are to achieve their promise in treating mental ill-health, what tools are available to promote and reward innovation and commercialisation in bringing improved therapies to market? With this question in mind, we address below two aspects of registrable intellectual property (IP), patents and plant breeder rights (PBRs), that could contribute to advancing psychedelic therapies.

Patents

According to the Poisons Standard June 2021 (a legislative instrument made under the Therapeutic Goods Act 1989), Schedule 9 is described as (emphasis added):

Prohibited Substance Substances which may be abused or misused, the manufacture, possession, sale or use of which should be prohibited by law except when required for medical or scientific research, or for analytical, teaching or training purposes with approval of Commonwealth and/or State or Territory Health Authorities.

Schedule 9 contains substances that should be available only for teaching, training, medical or scientific research including clinical trials conducted with the approval of Commonwealth and/or State and Territory health authorities. Although appearing as a Schedule in this Standard, the method by which it is implemented in the States and Territories may vary.

Section 50(1)(a) of the Patents Act 1990 (Cth) provides that (emphasis added):

The Commissioner may refuse to accept a request and specification relating to a standard patent, or to grant a standard patent for an invention the use of which would be contrary to law.

Accordingly, by use of discretionary rather than mandatory language, and despite Schedule 9 being for Prohibited Substances, neither the Patents Act 1990 nor the Poisons Standard June 2021 appear to prohibit patenting a Schedule 9 psychedelic.

Having said that, MDMA was developed by Merck in 1912 and psilocybin was isolated from the mushroom Psilocybe mexicana in 1959, so clearly, these psychedelics are not new, and therefore cannot be afforded patent protection, because they lack novelty. However, patent protection would be available for new and non-obvious:

In other words, despite some psychedelics with therapeutic benefits being known, there remains ample scope to develop patent coverage to promote commercialisation of psychedelic therapies.

Plant breeder/variety rights

In addition to the potential for obtaining patent coverage for genetically modified organisms producing a psychedelic or derivative, it would also be possible to obtain PBR if the genetically modified organism was a new variety of plant, fungus or alga (but not a bacterium, bacteroid, mycoplasma, virus, viroid or bacteriophage).

Further, PBR may be granted in addition to a patent. The terms of each form of IP may run concurrently, but conceivably, a new plant variety could be generated and covered by PBR after filing a patent application or even after grant of a patent to which the new variety relates. This could extend IP coverage related to a psychedelic or derivative beyond that of a patent. Notably, and in contrast to patents, PBRs run from the date of grant rather than the date of filing. For most plants, the term is 20 years, but for trees and some vines, the term is 25 years. As such, a PBR could extend considerably beyond a patent for related plant technology.

Other IP

Although we have discussed patents and PBRs, other forms of registrable IP such as trade marks (protecting a badge of origin) and designs (protecting visual appearance) may also be important for promoting commercialisation and bringing psychedelic therapies to market.

Originally posted here:

Recent progress in psychedelic therapies - Lexology

TORONTO -- Its been more than a decade since Bruno Guevremont returned to Canada from his military deployment to Afghanistan. Like so many other veterans, Guevremonts combat experiences took a mental toll.

During his second tour in 2009, Guevremont was part of a team that dismantled IEDs, or improvised explosive devices.

One incident, in particular, changed him. Guevremont says he was the first Canadian soldier ever to defuse a suicide vest on a living person. But it wasnt the high degree of danger in that situation that affected him.

The suicide bomber was mentally challenged. He had been told that if he doesn't do this, then they were going to kill his family, Guevremont told W5 correspondent Avery Haines. So that started playing with my mind.

After his return to Canada, Guevremont suffered panic attacks and suicidal thoughts. He was diagnosed with PTSD, depression and anxiety.

When talk therapy and anti-depressants didnt help, Guevremont sought alternatives in an attempt to recover his mental health. He joined an Arctic expedition with other veterans in 2014, captained Team Canada at the 2016 Invictus Games, and became a mental health spokesperson for Bell Lets Talk Day.

Then, in March, 2020, the COVID-19 lockdown sent Guevremont into a tailspin, and he contemplated suicide again.

I started getting really depressed, started getting dark thoughts, he told W5.

Thats when Guevremont learned about an unconventional treatment for severe depression and PTSD, involving the drug ketamine.

Ketamine is notorious for being a hallucinogenic party drug nicknamed Special K, a veterinary tranquilizer and an anesthetic thats been used in hospitals for over 50 years. But at sub-anesthetic doses, the drug has shown an ability to quickly reduce symptoms of depression and suicidal thinking, within weeks to hours.

The magnitude of improvement on the symptoms approaches in many studies between 40 to 70 percent improvement within a couple of weeks, noted Dr. Roger McIntyre, a professor of Psychiatry and Pharmacology at the University of Toronto. In 2018, McIntyre founded the Canadian Rapid Treatment Center of Excellence (CRTCE) - Canadas first private clinic to offer ketamine treatments for depression.

The Canadian Mental Health Association reports that approximately five per cent of Canadians are affected by major depression and more than 4,000 Canadians died by suicide in 2019.

Ketamine appears to be especially promising for people who have not had success treating their depression with conventional monoamine anti-depressants, which -- when they work -- also generally take four to six weeks to achieve maximal benefit.

This is truly a breakthrough, said Dr. McIntyre.

In November 2020, after his bout with depression, Bruno Guevremont travelled from his home in Victoria, B.C. to Field Trip Health, in Toronto - for orally administered ketamine treatment.

While ketamines anti-depressant effects are well documented, therapists at Field Trip Health also aim to maximize the psychedelic qualities of the drug and combine it with psychotherapy.

The transformation doesn't happen within the session itself. That happens before and after, when you are working on your trauma, when you're actually making sense of it, said Guevremont.

In 2020, Health Canada approved a ketamine-derived nasal spray for treatment-resistant depression and has allowed off-label use of the drug when administered intravenously or orally by health care professionals.

But a host of other illegal psychedelics and party drugs are also being studied for their therapeutic value. Among them, psilocybin, the psychoactive ingredient in magic mushrooms. Clinical trials with psilocybin have shown an improvement in symptoms for patients battling a range of disorders including depression and anxiety.

Though scheduled as a controlled substance, in 2020 Health Canada started offering what are known as Section 56 exemptions to patients with end-of-life distress so they could undergo therapeutic sessions with the drug.

Meanwhile, clinics that treat depression with ketamine are opening up across Canada. There are currently at least 12 private facilities and several hospital-based programs.

But ketamine treatments are not a cure or even suitable for everyone with mood disorders. Patients may be ineligible for treatment if they exhibit a history of psychosis, hypertension or substance abuse.

A typical ketamine treatment regimen involves 4 to 6 sessions over a two-to three-week period. Patients often need booster doses and the long term effects are still unclear, though researchers say there is little evidence to support addiction to the drug when its administered under medical supervision.

Also, the cost of private treatment isnt cheap -- $750 per ketamine session and $250 for each psychotherapy appointment at Field Trip Health, and approximately $850 per intravenous infusion at the CRTCE.

But for patients like Bruno Guevremont, treatments with ketamine have offered a renewed outlook.

Life is actually enjoyable, which is amazing, he said. I didn't want to be here. Now I do.

If youre in crisis, call 9-1-1 or go to your nearest emergency department.

24/7/365 Crisis Support Services from The Canada Suicide Prevention Service:

+1-833-456-4566

In Quebec: 1-866-277-3553

https://www.crisisservicescanada.ca/

Watch the episode this Saturday at 7 p.m. on CTV

More:

Ketamine and psilocybin, better known as party drugs, showing promise for treatment of mood disorders - CTV News

A scientist stands before a crowd in an Auckland pub with a microphone in his hand and asks them all a question.

Whos had something to drink? he asks. Hands up. And whos tripping? Its a serious question.

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Auckland University scientist Suresh Muthukumaraswamy describes himself as someone who gives people drugs and studies their brains.

The scientist is Suresh Muthukumaraswamy, an associate professor in psychopharmacology at the University of Auckland. The event is called Raising the Bar, when the university sends some of its experts out into the world for a night.

This particular one was at the Birdcage Tavern in April. More than a few people would have had a drink or two. But tripping? No-one put their hands up.

READ MORE:* Global Drug Survey: After-effects of drug use* What's the deal with microdosing?* Microdosing of drug LSD 'may improve psychological health'* Book Review: How to Change Your Mind: The New Science of Psychedelics, Michael Pollan* Party drug ketamine may soon show it can do what other medicines can't

It was an attention-getting opening, but Muthukumaraswamy, who describes himself as someone who gives people drugs and studies their brains, was making a serious point about his controversial subject, the mind-altering substance LSD.

The point is this. Having one or two social drinks is fine, but being blackout drunk is not so good. Perhaps LSD could be understood the same way. Perhaps a full-blown psychedelic trip is like being blind drunk. Perhaps we should be thinking about smaller amounts.

The word for this is microdosing, which became trendy first in Silicon Valley, based on a notion that a small amount of LSD can inspire creativity and original thinking. Muthukumaraswamy has estimated that around 1000 people in New Zealand microdose regularly.

But those people are conducting experiments on themselves. Muthukumaraswamy, who is running what he believes to be New Zealands first Class A psychedelic study, is doing it responsibly and legally.

Supplied/Stuff

Suresh Muthukumaraswamy, Associate Professor in Psychopharmacology, University of Auckland, studies the effects of LSD on the brain.

The trial involves 80 participants. Those who are given LSD rather than a placebo get small amounts, just 10 micrograms (10g) of the drug 14 times over six weeks, or on every third day. That amount would be about a tenth of a recreational LSD trip.

Rather than full-blown phantasmagoria, they would get barely a ripple. Its called a sub-perceptual level.

The trial started in 2021 and, due to lockdowns, wont be complete until 2022. The first dose was given in the lab, to check there werent unusual reactions, and then the volunteers were given the remaining doses to take home with them and use like any other medication.

Unlike some LSD research overseas, this is not about therapeutic use.

This is looking at their wellbeing, their creativity, cognitive function and just how well they tolerate doing this.

The trial is a first step, before he would try it on people with mood disorders and anxiety.

Was it hard to find participants? People are volunteering, Muthukumaraswamy says. People are really generous with their time. We ask quite a lot of them, actually.

A conversation with Muthukumaraswamy is surprisingly sober and straightforward, given the potentially lurid nature of the subject. Those three capital letters bring up all sorts of horror stories and past controversies, whether its images of 1960s LSD evangelists like Timothy Leary and Ken Kesey, or the CIAs mind-control experiments.

Supplied/Stuff

Ketamine pills produced for trials by Douglas Pharmaceuticals and the University of Otago.

There has been an enormous amount of interest globally over the past decade in what some see as the promise of previously stigmatised psychedelic and related substances. Not just LSD, but also psilocybin, which is the active compound in so-called magic mushrooms, ketamine and MDMA. Research demonstrates that, in controlled situations, these substances might cure depression, anxiety, post-traumatic stress disorder (PTSD), addiction and even the fear of death in terminal cancer patients.

But illegal drugs are also a hot-button topic, which means that a lot of media hype accompanies these findings. Miracles are promised. It was only last month that Newsweek magazine put some wizened mushrooms on the cover and announced that psilocybin was the biggest thing since Prozac.

A new age of psychedelic evangelism could be imminent, and that worries scientists like Muthukumaraswamy.

Im not an evangelist at all, he says. Im a data person. I think the field is in a dangerous position, where theres a lot of people who want things to work. That shouldnt be our job as scientists. Our job should be to describe reality and to conduct experiments that test hypotheses. We are humans, so we are naturally biased, but we should try to minimise that as much as we possibly can.

This is the renaissance of LSD research. Between 1943, when Swiss chemist Albert Hofmann first tried 250g of the chemical he synthesised five years earlier, and around 1970, more than 1000 scientific papers were published on LSD. More than 20,000 patients sampled it.

Some of this research was promising. Senator Robert Kennedy defended it, reportedly because LSD helped treat his wife Ethels alcoholism. But the drugs strong links to the civil unrest of the 1960s made legitimate research impossible.

That early research might provide some hints and pathways, Muthukumaraswamy says, but it lacks the rigour we expect now. And then the following 40 years of potential research was lost, for political reasons.

9News

Magic mushrooms have therapeutic potential.

While in the UK, after getting his PhD at Auckland University, Muthukumaraswamy was working with David Nutt, a giant in the field. He initially worked on some of the boring drugs that no-one cares about, before moving on to one of the early psilocybin studies.

When he came back to New Zealand, he started working on ketamine, because I could. It was relatively easy to get off the ground.

The problematic history of LSD is a bigger hurdle to overcome. Was it easy to get this approved?

The university has been pretty supportive, Muthukumaraswamy says. It takes a bit of time. You just have to work the right levers. The Ministry of Health is allowing us to do it.

There was a little bit of resistance, I would say, at the start. Ill be honest, it was really hard getting this study started, because it was the first one. Im hopeful that if we do more studies, follow-up studies, that will be less hard.

There will be a MDMA trial in collaboration with the University of Otago, and more to come on LSD microdosing.

Were hoping 2022 will be a real breakthrough year for us in terms of having maybe four or five different trials running.

There will come a point when you think youre going to die, but by then you really wont care.

That is how a person who must remain anonymous was briefed about a ketamine trip. That user describes what follows as the most powerful psychedelic experience Ive ever had in my life, and this person has tried almost everything.

There were hallucinations, there was powerful imagery and a feeling that one was losing ones mind. But as the trip adviser said, you have to just go with it.

Here is another vivid account of a ketamine experience.

The worlds frame rate dropped. I thought very hard about moving my hand, but it lagged behind; it looked grotesque and waxy, like the skin on cheese. I closed my eyes. That was a bad idea. I fell through my entire life and out the other side into death.

It must have looked horrible, because a doctor tried to console me by reading a passage from her book: Prehistoric wombats were over six feet tall. This was too much. I threw up everywhere.

That second experience, written by Asia Martusia King in Otago University student magazine Critic in 2020, was under the supervision of Dr Paul Glue, who has spent roughly a decade researching ketamines potential as a cure for treatment-resistant depression.

I thought her description was hilarious, Glue says.

King had responded to a call for volunteers. She reported that once the lurid effects wore off, she enjoyed a week of feeling good.

While resistant to talking about miracles, Muthukumaraswamy has been impressed by the effect.

Its fascinating, if someone has had depression for so long, and they can be given something that flicks the switch, and they feel better. Its not that theyre high. They feel better the next day. We know the ketamine has left their body, but theyre still undepressed over the course of the next week, which means its done something in their brain to modify their brain circuits to make their moods better.

That suggests theres a switch in there that can be flicked. Thats the interesting question.

Many people are looking for answers to that question. One of the details is that ketamine appears to work on depression within a week, whereas the selective serotonin reuptake inhibitors (SSRIs), such as fluoxetine, that are dispensed to around 9 per cent of adults in New Zealand, take four to six weeks.

Compared with regular antidepressants, this is blazingly fast, Glue says.

Ketamine is used as an anaesthetic in New Zealand. There is also a nasal spray available, but it is expensive and rarely used. Otherwise, ketamine is a Class C drug here.

It has found recreational users, who called it Special K and talked about the dissociative, death-like experience as going through the K-hole.

The question that preoccupied Glue is how to use it to treat depression while avoiding its terrible effects. In about 2015, he had a fateful meeting with Peter Surman, chief scientific officer with Auckland company Douglas Pharmaceuticals. Glue had previously worked with Surman on a liquid form of the schizophrenia treatment Clozapine.

Supplied/Stuff

Peter Surman, chief scientific officer at Douglas Pharmaceuticals.

That went really well, Surman says. Its now globally available. Pauls got a very good understanding of industry as well as academia.

An idea was hatched. You could produce a ketamine tablet for the depressed patients who dont respond to SSRIs. And it could be a slow-release drug, so that 120 micrograms (120mg) could leak out gradually rather than all at once.

To cut a long story short, the pill, which is dubbed R107, has just had very promising results from a phase two trial on patients in New Zealand and Australia, plus a handful in Singapore and Taiwan, and a phase three trial starts next year.

What weve seen is on day eight, when they get their scoring done for level of depression, 75 per cent of them are well, Surman says.

On the Montgomery-Asberg Depression Rating Scale (MADRS), they now have scores below 12, which is really good. Zero to 6 is normal and 7 to 19 is mild depression. Many started with scores in the 30s, which is severe depression.

So all the hallmarks are there that this drug is actually working and is providing a response in patients, Surman says. Many of them have been sick for years or decades. Its a really positive feeling for us when the investigators or the primary care physicians say, Look, I dont want to take the patients off this.

What happens now? The likely timeframe is to submit the drug to the Food and Drug Administration (FDA) in the US for approval in 2025. The whole world watches what the FDA does, and to recover the cost of the development, which is significant, you need to have the US a party to it.

And then, hopefully the first launch will be 2026 in treatment-resistant depression, Surman says.

It has huge potential. Its going to be too deep for our pockets to do the US launch and the distribution, but well be working with a commercial partner, and that partner may see sales of US$2 billion or more on that product line. Thats what the forecast need is. It could be a blockbuster with the right partner.

Depression and anxiety, which Glue's ketamine research has also tackled, are growing mental health epidemics.

There have been literally hundreds of groups around the world who have shown it works in depression, Glue says. The bit weve added is to show it works in anxiety as well. People with bad generalised anxiety, social anxiety, about an hour after dosing, about 70-80 per cent of them will say, My symptoms have gone.

Of those with anxiety, around a quarter remained well and half had lessened anxiety. Is that a good result?

Its a spectacular result. The natural history of anxiety disorders is you get them as a child or an adolescent, and theyre with you pretty much for the rest of your life. It tends to be a neglected disease. Its one of the big high-prevalence disorders and there are very few novel treatments for it. So that a quarter of people after three months didnt get their anxiety back is striking.

The FDA is on the lookout for safe products that are going to help with people who are really suffering, Surman adds.

Of course, the psychedelic goldrush means that Douglas Pharmaceuticals is not the only company with a bright idea.

Absolutely, Surman says. Any idea thats a good idea, people soon pick up on it, and we know theres a few companies looking at ketamine at the moment.

I think were in a good position. But we cant take our foot off the gas. We have to get an application into the United States. Thats really critical. As quickly as possible.

Supplied/Stuff

Dr Geoff Noller, a medical anthropologist in the Dept of General Practice and Rural Health, University of Otago.

Paul Glue had just received good news on the day Stuff rang. He learned that the collaboration with the University of Auckland on a MDMA study had won ethics approval. They hope to start in about six months. Its taken two years to get to this stage.

The notion is to use MDMA to help treat anxiety and depression in people who have terminal cancer. It follows one of the most celebrated studies from the psychedelic renaissance, conducted by Roland Griffiths of Johns Hopkins University in the US, using psilocybin.

Griffiths found that in those patients, high doses of psilocybin increased their quality of life, their sense of meaning and optimism, and lowered their death anxiety.

An earlier paper by Griffiths showed that psilocybin can occasion mystical-type experiences that have substantial and sustained personal meaning and spiritual significance.

But words like mystical and spiritual make some people worried. Its not just that it harks back to the 1960s, and the utopian free-for-all of Leary and Kesey. It also moves beyond treatment, as surely we could all benefit from mystical, meaningful experiences, not just those who are unwell.

This is the dilemma writer Michael Pollan arrived at in his book How to Change Your Mind: The New Science of Psychedelics, when Griffiths told him that these drugs will be far too valuable to limit to sick people.

The difference can be illustrated on the Otago campus. Geoff Noller works at the same university as Paul Glue, but is an anthropologist by training, with an understanding of how drugs are used culturally, not just medically.

Antoine Julien/Unsplash

MDMA and ketamine are popular dance party drugs, but they also have therapeutic potential.

Im an anthropologist, and Im fascinated by consciousness, Noller explains. I would say that one of the most important elements of treating people with these drugs is that journey people go on. Paul is a psychiatrist. Hes interested in the brain and not the mind.

Griffiths paper about the mystical properties of psilocybin followed a reconstruction of what was called the Good Friday experiment of 1962, when divinity students in Boston were dosed with the drug and had spiritual experiences in a church.

It said much about what they call set and setting, the importance of the mindset and the environment, and therefore about suggestibility. As Noller says about Griffiths experiment, many reported a peak experience, and still felt that way 18 months later.

That is an example of the power of these substances to have an effect that is not just ephemeral, but lasting.

As an anthropologist, Noller is aware this is a near-universal impulse. Every society he knows about, except Mori, has a substance that alters consciousness. Mori knowledge may have been hidden by the Tohunga Suppression Act, he thinks.

Presumably Mori living very close to the land would have been familiar with the effects of psychedelic mushrooms.

Noller is especially knowledgeable about Ibogaine, a powerful but dangerous drug that is used in west African religion.

They call it breaking the head. The idea is to crack open ones consciousness and engage with issues within oneself. Not in a drug treatment sense but just in a general sense of exploration, I suppose.

The drug treatment part is that Ibogaine is used by some to cure opioid addiction. The downside is that it can also produce a fatal arrhythmia, and there was a death during treatment in Kaitaia in 2013.

It is said to produce a dream-like state that is far from pleasant, in which ones life appears before them, forcing them to confront the trauma or physical injury that caused their addiction.

Not exactly a great Saturday night out, Glue quips.

You really do need to know what youre doing in terms of treating someone, Noller agrees.

Noller is also an enthusiast of cannabis law reform who wrote, somewhat presciently, in 2017 that cannabis policy is too important to leave to politicians. Yes, he was disappointed about how it went in 2020, but also not surprised.

A crude moralistic division exists between good and bad drug-taking, expressed in public views about medicinal cannabis versus weed smoking. You can see similar divisions in the psychedelic world now.

Read more here:

Miracles and medication: The new science of psychedelic drugs - Stuff.co.nz

UAB researchers will study psilocybin, a psychedelic compound, on its effects on smoking cessation.

Peter Hendricks will study psilocybin, a psychedelic compound, on its effects on smoking cessation.Researchers at theUniversity of Alabama at Birmingham, Johns Hopkins University and New York University were awarded nearly $4 million in funding to study the efficacy of psilocybin, a classic psychedelic compound, in helping people quit smoking. The grant from the National Institute on Drug Abuse is the first federally funded study of a classic psychedelic as a therapeutic in approximately 50 years.

This is a groundbreaking study that opens the door to further study of psychedelic compounds, said Peter Hendricks, Ph.D., professor in theDepartment of Health Behaviorat the UABSchool of Public Healthand a site principal investigator. These compounds could be game-changers for the future of mental health and addiction care.

A resurgence in research of classic psychedelics over the past two decades has shown the benefits of the compounds in the mental health and addiction fields, says Hendricks. The studies, funded mostly by philanthropy efforts, have led to impressive clinical findings, specifically with end-of-life distress, major depressive disorder and substance use disorder. While compounds such as psilocybin have risks, previous studies have shown these risks can be controlled and mitigated through screening, preparation, monitoring and follow-up care.

Peter Hendricks, Ph.D.(Photography: Lexi Coon)Hendricks, Matt Johnson, Ph.D.,Susan Hill WardProfessor of Psychedelics& Consciousness Research at JHU, and Michael Bogenschutz, director of the NYU Langone Center for Psychedelic Medicine, will conduct the three-year study at each of their respective institutions. The multi-site approach provides a diversified pool of participants and increases confidence that results should apply to a wide range of people who smoke.

Even the very best existing smoking cessation treatments those that include both counseling and medication yield abstinence rates of only 30 percent or so, Hendricks said. This means, if we gave 100 smokers the very best treatment money can buy, only 30 would actually quit. We need to do better. Psilocybin has the potential to significantly improve the effectiveness of smoking cessation treatments. Considering almost half a million Americans die from smoking every year, this could end up saving millions of lives, if not more.

Hendricks and his co-investigators have studied classic psychedelics for years and have extensive experience in studying psilocybin and addiction treatment research. Hendricks is also known for his research in tobacco and smoking cessation.

Read the original:

UAB researcher granted federal funding for psilocybin and smoking study - The Mix

NEW HAVEN, Conn. (WTNH) Psychedelic drugs are making a comeback but this time its in laboratories. Researchers at Yale are harnessing their powers to try and treat conditions like depression and mental illness.

The active ingredient in so-called magic mushrooms is called psilocybin. Researchers use psilocybin in a synthesized form on mice (they dont use actual mushrooms).

Theyre trying to connect neurons in the brain to help treat depression.

We find that with a single dose of psilocybin a mouse actually has more neuro nerve connections so this increase was quite immediate, says Alex Kwan, PhD, Yale School of Medicine Researcher and Associate Professor of Psychiatry and of Neuroscience.

Kwan says the effects were long-lasting.

So it seems like the drug itself can actually alter the architecturewithin the mouse brain at least.

Kwan first was involved in the research of ketamine, which now has FDA approval to treat depression with a nasal spray.

And while the compound from psychedelic mushrooms may work on the mouse brain, he points outThey are not tiny humans. This is not approved for human use yet.

The discoveries could open even more doors.

One of the fascinating things about psychedelic is that there are ways to modify it so you can have literally hundreds of thousands of analogs that are slightly different chemically that might also have distinctive behavioral effects in humans.

Kwan points out the large toll mental illness takes on society and says that some people do not respond to SSRIs drugs like Prozac. This could be the answer. Possibly.

The early hints are promising but I think more work needs to be done.

Go here to read the rest:

Yale researchers using psychedelics to find new treatments for depression - WTNH.com

ANN ARBOR, MI Organizers of Ann Arbors first-ever psychedelic shroom fest are expecting this weekends event to draw a big crowd of people from all around the country.

If youre planning to attend or just curious to know more about it, heres what you need to know.

1. When and where is it?

The festival is expected to take place on the University of Michigan Diag off State Street from 11:11 a.m. to 2:22 p.m. Sunday, Sept. 19. Public parking is free and plentiful in downtown Ann Arbor on Sundays, so parking should be no issue for attendees.

2. What does the event entail?

Officially called Entheofest, its a celebration of entheogenic plants and fungi, featuring musical entertainment and speeches by psychedelic activists and elected officials who support decriminalization of natural substances such as ayahuasca, ibogaine, mescaline, peyote, psilocybin mushrooms and other natural compounds with hallucinogenic properties deemed illegal under state and federal law.

3. Who is behind it?

Its being organized by Decriminalize Nature Michigan and the Student Association for Psychedelic Studies, who are supporting decriminalization efforts across the state following last years successful campaign in Ann Arbor.

4. Why is it happening?

Sundays event is intended to celebrate the one-year anniversary of Ann Arbors move to declare entheogenic plants and fungi the citys lowest law-enforcement priority, effectively decriminalizing them at the city level.

City Council recently approved a resolution recognizing Entheofest and declaring September to be Entheogenic Plant and Fungi Awareness Month, in hopes of increasing understanding of the potential benefits of psilocybin mushrooms and other psychedelics for mental health, personal and spiritual growth, as well as honoring the longstanding ancestral practices and relationships with these entheogens.

5. Is it officially allowed?

The University of Michigan has OKd the student organizing groups request to reserve the Diag off State Street for the event, though campus police, who enforce state and federal laws, are expected to be on hand to ensure public safety.

Organizers are asking attendees to use the event as an opportunity to celebrate and learn about the sacred medicines and decriminalization efforts and not as a space for consumption of psychedelic plants and fungi.

MORE FROM THE ANN ARBOR NEWS:

Ann Arbor psychedelic shroom fest organizers announce entertainment lineup

University of Michigan police say safety will be top priority at psychedelic shroom festival

Psychedelic shroom fest gets green light from University of Michigan

Tree Town under attack? Ann Arborites decry tree butchering by DTE Energy

Two-tower development on former Ann Arbor YMCA property awaits citys OK

Read the rest here:

5 things to know about the Ann Arbor psychedelic shroom fest - MLive.com

Retail investors are getting new tools for gaining exposure to the booming medicinal psychedelics industry.

On Thursday, AdvisorShares launched the countrys first actively managed ETF covering the psychedelics sector.

The AdvisorShares Psychedelics ETF (NYSE:PSIL),launched on the NYSE Arcamarket,

providing exposure to biotechnology, pharmaceutical and life sciences companies that the firm deems are leading the way in this nascent industry.

So far, this is the third ETF covering the psychedelics sector in North America. The Horizons Psychedelic Stock Index ETF (NEO: PSYK) was first to launch in January of this year, followed by Defiances Next Gen Altered Experience ETF (NYSE:PSY), which broke ground as the first passive U.S.-listed ETF in the sector.

Active management means that the portfolio manager can adjust the portfolio more quickly and opportunistically than a passive index-based ETF, though more responsibility is placed on the funds management.

Ongoing and growing research has shown various psychedelic substances offering promising medical and therapeutic potential for treating mental health issues and neurological disorders. PSIL concentrates its portfolio on companies deriving the majority of their net revenue or devoting the majority of their assets to psychedelic drugs,AdvisorShares explained.

Dan Ahrens, CEOof AdvisorShares and portfolio manager of PSIL, said he believes that byinvesting in select companies in the psychedelics space, his firm can provide a compelling long-term investment opportunity. Still, the CEOsaid this is also an area of the marketplace in its early innings.

We feel that our active-management and specialized approach can potentially help investors capture the early growth potential of psychedelics and its prominent promise on therapeutics and medical fields, Ahrens added.

Benzinga Photo.

Read more:

Want Quick Exposure To The Psychedelics Sector? Check Out This New Active ETF - Benzinga - Benzinga

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Two years after the U.S. Food and Drug Administration (FDA) declared the hallucinogenic substance psilocybin a breakthrough therapy to speed the process of the drugs scientific clinical trials and reviews (https://ibn.fm/umfbQ), Michigan continues to cement its reputation as a hotbed for medicinal psychedelics advocacy and research, and proponents there believe society has reached a watershed moment for the substances acceptance.

Law enforcement officials in the states Ann Arbor region have effectively decriminalized natural compounds with hallucinogenic properties deemed illegal under state and federal law (although not synthetic compounds such as LSD), and last month Ann Arbors City Council voted 10-0 to&

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NOTE TO INVESTORS:The latest news and updates relating to TRYPF are available in the companys newsroom at https://ibn.fm/TRYPF

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Differentiated Approach in Psychedelics Boosts Confidence in Upcoming Clinical Trials for Tryp Therapeutics Inc. (CSE: TRYP) (OTCQB: TRYPF) -...

This article was originally published on Microdose and appears here with permission.

The psychedelic medicine industry has been growing at an impressive rate. Big players like Atai (NASDAQ:ATAI) have joined the ranks, adding billions of dollars of investor interest; and smaller upstarts likeFilament HealthandLevitee Labshave made their public debuts, adding a diversity of approaches to the space.

All this expansion makes it easy for some companies to get lost in the shuffle. One such firm going somewhat under the radar is Pharmather Holdings Ltd (OTC:PHRRF).

But perhaps we should be paying closer attention. As the industry focused on big-name news, PharmaThers stock price has been on a low-key moon run these last few months. Between end-April and end-July the companys stock price soared approx 375% (from $0.24 to a high of $1.14), before settling down in the $0.90-$1.00 range.

Why the sudden jump? What has the market seen in PharmaTher that we should perhaps know about?

Lets use the companys recent end-of-year financial highlights to help take a closer look.

This week PharmaTher released business and financial results for its fiscal year ended May 31, 2021. Lets have a look at some of the highlights (all figures in Canadian dollars and information taken from thecompanys press release)

This seems to bethe newsthat got the stock rolling. Announced in mid-May, this approval to begin Phase 2 clinical trials moved PharmaTher into an elite group of companies in advanced clinical trials. The positive price movement started around this time.

Theannouncement of this saleseemed to signal that PharmaTher was going to focus on its strengths, which at the moment are its ketamine treatments and delivery technologies. The move gave them a good chunk of cash and was a bold move considering how popular psilocybin development is. So far it seems to have paid off.

All of the above are further proof of the company focusing its efforts on advancing its current stable of promising products. While a diverse pipeline is important, so is showing results and getting a product to market.

Here are some other announcements that came after the firms year-end:

It seems the company has a good working relationship with the FDA and is taking advantage of the agencys positive view of ketamine. Another Phase 2 trial for something as big as depression would be major news.

From Fabio Chianelli, Chief Executive Officer of PharmaTher: Receiving FDA orphan drug designation is a massive validation for ketamine as a potential treatment for ALS, and it allows us to confidently proceed in evaluating ketamine in phase 2 clinical study in patients suffering from this life-threatening disease. This designation not only expedites our regulatory, clinical, and product development plans but also validates our belief in the potential of ketamine as a therapeutic solution for neurological disorders.

Cash on hand gives them about another year of capital (if spending stays relatively the same). This is a bit light and you can probably expect another capital raise soonsomething the recent jump in stock price will help with.

Overall it seems PharmaTher is making solid progress, focusing on its best products, and building itself into one of the leaders in ketamine development. And for now, the markets seem to agree.

Perhaps its time to keep a closer eye on this company. Stay tuned to Microdose for more.

See more here:

A Look At Psychedelics Stock PharmaTher And Its Recent Bull Run - Benzinga - Benzinga