Daily Archives: January 5, 2024

Understanding the Role of the FDA

The U.S. Food and Drug Administration (FDA), a division of the Department of Health and Human Services, is entrusted with safeguarding public health. This involves ensuring the safety, effectiveness, and security of a wide range of products, including drugs, vaccines, medical devices, food supply, cosmetics, dietary supplements, and tobacco products. Among the many areas under its purview, the FDA also oversees the regulatory aspects of psychedelic clinical trials, and the current research in this area is gaining momentum.

In a bid to advance the field of psychedelic research, the FDA has announced a two-day virtual public workshop titled Advancing Psychedelic Clinical Study Design in collaboration with the Reagan-Udall Foundation. The workshop aims to gather researchers, regulated industry representatives, and other stakeholders to discuss scientific issues related to working with psychedelics in clinical trials and drug development. The FDA issued its first draft psychedelics guidance for the industry in June 2023, offering general considerations to sponsors developing psychedelic drugs for the treatment of medical conditions.

Research into the therapeutic benefits of psychedelic drugs dates back 80 years. However, government regulations have long hindered progress in this field. In recent years, there has been a resurgence of interest in the benefits of psychedelic medicines, leading to clinical trials for treating conditions like treatment-resistant depression and PTSD. The FDAs new draft guidance for researchers investigating the use of psychedelic drugs for potential medical treatment signals a promising pathway to approval. Despite the logistical challenges of conducting clinical research and ensuring patient safety, there is a potential move towards refining the therapeutic benefits of these drugs while minimizing their psychedelic effects.

The American Medical Association has set new standards for assigning specific codes to psychedelic therapies for data collection on novel treatments. In July, the AMA approved Current Procedural Terminology (CPT) III codes for psychedelic medicines, facilitating health providers in seeking coverage and reimbursement for these treatments. Alongside this, the FDA is considering an application to approve MDMA as a prescription drug, with MAPS PBC requesting an expedited six-month review instead of the standard 10-month review. If approved, it would mark a historic moment, making MDMA the first psychedelic to be approved as a pharmaceutical to be administered with psychotherapy and other supportive services.

The FDAs draft guidance for researchers interested in developing psychedelic drugs for the treatment of medical conditions has sparked optimism in medical communities. This shift in attitude is seen against the backdrop of the historical context of psychedelics, the Controlled Substance Act, and the resurgence of research funding for psychedelics. Notably, the FDA has already approved esketamine for the treatment of depression in adults, paving the way for further research and harnessing the potential therapeutic benefits of psychedelic drugs.

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Understanding the Role of the FDA in Advancing Psychedelic Therapy - Medriva

Amy, Henry and Protik then took to the stage, with Emerson kicking off a fireside-type discussion with the Helena executives.

But why had Helena, which has invested in grid-scale energy storage and carbon-negative diamonds, become so interested in psychedelics?

The shit works, Elkus responded when asked what drew him into the space. The data on this is so incredibly compelling, it kind of doesnt even require using stage time to talk about it.

In what followed, Elkus echoed Doblins assessment of todays crisis state of humanity and talked of a present real risk moment for human civilisation, adding that you cannot solve any problem without, as a prerequisite, human coordination [], human empathy.

In MAPS PBC and psychedelics (drug development) more broadly, then, Elkus sees a dual benefit.

MDMA-assisted therapy, for example, represents something that in the here and now works, but also something that in the medium- and long-term, if we introduce these concepts to civilisation, could kind of end the model of accumulation without empathy or without distribution. Thats what I think psychedelics can allow for the rest of the 21st century, Elkus said.

And so to have an opportunity to work on both of those at the same time, especially without them cannibalising each other, is a once in a lifetime opportunity, he said, and were just glad to be here.

Helena was founded by Elkus, who dropped out of Yale in his second year to dedicate himself full-time to the project. His father, Bill Elkus, founded Clearstone Venture Partners in 1997, which invested in PayPal among other tech startups.

In a 2017 Huffington Post interview, Elkus described Helena as a new type of organization that was structurally designed for 21st century problems, and I wanted to do my part and create one.

At the Psychedelic Science 2023 fireside discussion, Helena Managing Partner Basu explained that the organisation has both a not-for-profit arm (a kind of policy arm) as well as a for-profit investment fund.

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MAPS PBC Closes $100m Series A, Rebrands to Lykos Therapeutics - Psychedelic Alpha

The European Union stands at a critical juncture in addressing the escalating crisis of mental health disorders. With the ongoing review of EU pharmaceutical legislation, there is a pressing need to realign our healthcare innovation priorities to better address the unmet needs in mental health care.

Current data paints a concerning picture of the mental health burden in Europe. According to the OECD, half of the population will face mental illness at some point in their lives. (1) In the EU, 32 million citizens (7.2%) suffer from chronic depression, (2) a condition with a high risk of suicide. WHO Europe reports that 75% of major depression cases lack adequate treatment. (3) Up to 50% of treated patients experience treatment resistance, (4) and nearly one-third will attempt suicide. (5) Annually, 130,000 Europeans die by suicide. (6) These stark realities underscore the urgency of addressing mental health as a public health priority.

Despite the clear need, the innovation landscape in mental health care is lagging. Current estimates suggest that by 2040, we will only be able to prevent 14% of the burden arising from mental health conditions. (7) The pharmaceutical sector has seen limited progress in developing new treatments for mental health. There are approximately 30 different antidepressants, 20 antipsychotic drugs, seven mood stabilizers for bipolar disorder, and six different classes of drugs for ADHD available. Regrettably, almost none of these are more effective than the medications available three decades ago, despite some improvements in side-effect profiles. (8)

Last year, of the 89 new medicines recommended for approval by the European Medicines Agency, not a single one targeted mental health conditions. (9) Since 2015, only seven neuropsychiatric drugs have been approved globally, in stark contrast to the 80 drugs approved in the field of oncology. (10)

This innovation gap in mental health care is a significant concern. Against this backdrop, among the most promising areas in mental health innovation are novel psychedelic treatments. These therapies have shown potential in clinical trials, offering rapid and durable effects in treating various mental health conditions and substance use disorders. These therapies offer new hope for many patients, particularly those who have not found relief through conventional treatments.

The global landscape for psychedelic therapy is evolving rapidly. This year, Australia became the first country to officially regulate the medical use of psychedelics for the treatment of PTSD and depression. In the US, the first psychedelic therapy is anticipated to be approved by 2024.

Despite significant progress in this field, Europe currently faces a shortfall in late-stage programs that facilitate the approval of new treatments. Numerous early and mid-stage trials are underway within Europe, and the continent has been a fertile ground for pioneering insights in psychedelic research, largely thanks to the contributions of European scientists and study participants. Nevertheless, the majority of the regulatory support and flexibility that encourages the advancement of these treatments into their final stages of development is predominantly seen outside of Europe. This disparity poses a risk of Europe lagging in the international effort to develop and authorize these groundbreaking treatments.

The EU has previously demonstrated its ability to incentivize R&D in specific areas, such as orphan and paediatric medicines. This success can serve as a model for mental health care. By leveraging the pharmaceutical legislation review, the EU has the opportunity to foster innovation and support the development of novel mental health treatments.

To make this possible, the current EU criteria for unmet medical needs need to be expanded from merely looking at life-threatening or severely debilitating conditions to including the prevalence of conditions and their societal impact. This call was included in a recently launched European Parliament policy paper Unmet Medical Needs: Aligning Medical Innovation with Societal Health Needs authored by the Psychedelic Access and Research European Alliance (PAREA).

The paper also calls for the establishment of a European Hub for Mental Health R&D. This hub would unite EU institutions, Member States, healthcare funders, and philanthropic organizations to foster evidence-based decision-making in mental health and to set effective incentives and prioritize resources, driving innovation and addressing the substantial unmet medical needs in mental health care across Europe.

The EU is at a crossroads in mental health care. The choices made today in the realm of pharmaceutical legislation will have far-reaching implications for the future of mental health care. It is our collective responsibility to ensure that these choices pave the way for a healthier, more resilient society where mental wellbeing is not just an aspiration but a reality.

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Closing the innovation gap: Advancing psychedelic therapy and medicines in EU mental health care - Open Access Government

Ibogaine is currently among the buzziest psychedelics, promising to upend the landscape of mental health care and support. First discovered to curb addiction in the 1960s, the drug was declared an illegal substance by the 1970s. Now, ibogaine is making a comeback not only for treating addiction but anxiety, depression, and now traumatic brain injuries.

In a study published Friday in the journal Nature Medicine, military veterans with mostly mild traumatic brain injuries underwent a combination treatment of magnesium and ibogaine in Mexico, where the psychedelic is legal. One month following their treatment, the individuals reported feeling immense relief from symptoms associated with post-traumatic stress disorder (PTSD), anxiety, and depression, as well as improved cognition.

No other drug has ever been able to alleviate the functional and neuropsychiatric symptoms of traumatic brain injury, Nolan Williams, an associate professor of psychiatry and behavioral sciences at Stanford University School of Medicine, who led the study, said in a press release. The results are dramatic, and we intend to study this compound further.

Ibogaine is a naturally occurring compound found in the roots of a shrub called Tabernanthe iboga, which is native to Central Africa and has been used for centuries for ceremonial practices.

Ibogaine acts as a stimulant in small doses but is a powerful psychedelic in large doses. What it does in the brain, however, isnt well understood. Studies in rats show that ibogaine may increase proteins that encourage neuroplasticity, which could explain how it helps the brain rewire itself, overcoming seemingly hard-set neural patterns of addiction.

While ibogaine isnt legal in the U.S., that hasnt deterred a growing number of individuals from flocking to clinics in Mexico (where the substance is unregulated) seeking treatment for addiction and other mental health issues.

There were a handful of veterans who had gone to this clinic in Mexico and were reporting anecdotally that they had great improvements in all kinds of areas of their lives after taking ibogaine, Williams said. Our goal was to characterize those improvements with structured clinical and neurobiological assessments.

To do this, Williams and his colleagues at Stanford recruited 30 military veterans who had been in special operations with a history of traumatic brain injuries a condition causing other mental health issues like PTSD, depression, and anxiety and repeated blast or combat exposures. The participants first underwent neuro- and psychological evaluations at Stanford and, a few days later, traveled by themselves to the Ambio Treatment Clinic located in Tijuana, Mexico.

At the clinic, the group took an oral dose of ibogaine paired with an intravenous drip of magnesium to prevent any side effects to the heart and cardiovascular system, which the psychedelic is known to do. Participants also participated in some wellness activities while at the clinic, such as reiki, meditation, yoga, and massage. They were then re-evaluated at Stanford four to five days and one month after the ibogaine treatment.

The results were significant. The average disability score for the participants before the treatment was equivalent to mild to moderate disability. This changed to no disability on the one-month follow-up. The veterans also reported, on average, an 88 percent reduction in symptoms associated with PTSD, 87 percent for depression, and 81 percent in anxiety relative to before the ibogaine treatment. They also did much better on their cognitive tests with respect to overall concentration, information processing, memory, and impulse control.

Before the treatment, I was living life in a blizzard with zero visibility and a cold, hopeless, listless feeling, Sean, a 51-year-old veteran from Arizona with six combat deployments who participated in the study, said in the press release. After ibogaine, the storm lifted.

These findings complement other studies involving military veterans that, similarly, have found ibogaine vastly improved cognitive impairment, PTSD, anxiety, and depression.

In light of the promising research thus far, pharmaceutical companies are already gearing up to develop drugs from ibogaine. German-based atai Life Sciences made an ibogaine formulation to treat opioid-use disorder that completed an early phase clinical trial in the U.K. At the University of California, San Francisco, researchers developed an antidepressant that mimics ibogaines impact on the protein that transports the neurotransmitter serotonin.

Since this study was purely observational, Williams and his colleagues are interested in expanding their research to include brain imaging to see exactly what sort of structural changes or otherwise are going on. The researchers believe ibogaine could be a veritable game-changer not just for traumatic brain injuries but a whole laundry list of neurological and psychiatric conditions.

In addition to treating [traumatic brain injury], I think this may emerge as a broader neuro-rehab drug, Williams said. I think it targets a whole host of different brain areas and can help us better understand how to treat other forms of PTSD, anxiety, and depression that arent necessarily linked to TBI.

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This Forgotten Psychedelic Could Revolutionize Traumatic Brain Injury Treatment - Inverse

Psychedelics made their mark this yearnot as counterculture party drugs, but as a new paradigm in mental health therapy.

In June, Australia became the first country to greenlight MDMA, popularly known as molly or ecstasy, and psilocybin, the active ingredient in magic mushrooms, to treat post-traumatic stress disorder (PTSD) and depression.

MDMA also inched closer to approval in the US for PTSD, thanks to positive results from a large multi-site, double-blind, randomized trialthe gold standard for testing drug safety and efficacy.

Meanwhile, psilocybin gained steam as a treatment for severe depression. A randomized, placebo-controlled trial in 104 adults found that a single dose of magic mushrooms dampened the symptoms of depression when combined with psychological support. The effects lasted at least six weeks with minimal side effects. Clinical trials are in the works to explore whether psilocybin and its derivatives can help patients cope with chronic lower back pain, tackle depression in bipolar disorder, and ease mental struggles in end-of-life care.

This year also saw magic mushrooms for therapy move ahead. Registered clinics in Oregon have already begun psilocybin treatments in patients with mental health disorders ranging from obsessive-compulsive disorders to PTSDeven though the drug isnt federally approved and remains illegal.

In 2022, Oregon became the first state to legalize psilocybin therapy with strict regulations: The mushrooms are carefully controlled for potency and quality and need to be taken under supervision. The guidelines offer a blueprint for other statessuch as Colorado, which also decriminalized psilocybin for potential therapeutic use.

Yet one glaring problem remains. Despite promising clinical results, no one knows exactly how psychedelic drugs work in the brain. Examining their actions on brain cells isnt just an academic curiosity. It could give rise to variants that maintain antidepressant properties without the high. And because hallucinogens substantially alter our perception of the world, they could be powerful tools for investigating the neurobiology behind consciousness.

Mind-altering drugs are fabulously dirty, in that they act on multiple targets across the brain, with each activating different types of neurons in diverse regions.

However, they share similarities. For example, most psychoactive drugs regulate serotonin, a brain chemical involved in mood, appetite, memory, and attention.

This year, scientists found another common themepsychedelics seem to reset the brain to a more youthful state, at least in mice. Like humans, mice have an adolescent critical period, during which their brains are highly malleable and can easily rewire neural circuits, but the window closes after adulthood.

An earlier study showed that MDMA reopens the critical window in adult mice, so that they change their personality. Mice raised alone are often introverted and prefer to keep to themselves in adulthood. A dose of MDMA increased their willingness to snuggle with other miceessentially, they learned to associate socializing with happiness, concluded the study.

Its not that surprising. MDMA is well-known to promote empathy and bonding. The new study, by the same team, extended their early results to four psychedelics that dont trigger fuzzy feelingsLSD, ketamine, psilocybin, and ibogaine. Similar to MDMA, adult mice raised alone changed their usual preference for solitude when treated with any of the drugs. Because habits are hard to change in adulthoodfor mice and menthe drugs may have reopened the critical period, allowing the brain to more easily rewire neural connections based on new experiences.

People with depression often have rigid neural networks that lock them into non-stop ruminations and dark thoughts. Psychedelics could potentially be a master key that helps brain networks regain their fluidity and flexibility.

Surprisingly, despite vastly different chemical structures, all the tested psychedelics activated a brain protein called brain-derived neurotrophic factor. A nutrient for brain cells, the protein helped brain regions involved in memory and mood give birth to new neurons. It also restored damaged neural branches, so neurons could better connect into functional networks.

Classic antidepressants such as Prozac also activate the protein, but psychedelics are far more effective. It could be why they rapidly relieve depressive symptoms within hours, whereas conventional alternatives often take months.

That said, being high all the time is hardly practical.

Another study suggests that it might be possible to separate a drugs mind-bending and mood-boosting effects. By studying brain networks in mice tripping on LSD, the researchers pinpointed a key hub for the drugs anti-depressant effects. Genetically deleting the protein hub reduced anti-depressant effects, but kept the high (on acid, mice bob their heads nonstop as if jamming to the Grateful Dead). The results suggest it may be possible to develop LSD variants that skirt unwanted hallucinations but keep their rapid antidepressant properties.

These are just early results. But psychedelic research is gaining a new allyartificial intelligence. Algorithms that predict protein structure, combined with rational drug design, could generate psychedelics that retain their psychiatric benefits without the high.

Machine learning could also further help decipher their effects on brain activity. For example, a collaboration between McGill University in Canada, the Broad Institute at Harvard and MIT, and other institutions is using AI to explore how hallucinogens alter different chemical systems in the brain.

The method is outside-the-box: The study designed an algorithm that analyzed 6,850 trip reports from people who took a range of 27 different drugs and cataloged their subjective experiences in everyday language. The AI extracted commonly used words for any given substance and linked them to brain chemical systems across brain regions that are likely affected by that particular drug. In other words, the AI reliably translated real-world experiences into potential chemical changes in the brain for researchers to explore. A similar tool could link drug-induced changes in consciousness to different brain regions.

Despite growing enthusiasm, hallucinogens and empathogenssuch as MDMAremain federally illegal. The Drug Enforcement Agency classifies them as Schedule I, meaning the agency considers them drugs without known medical uses and high risk of abuse.

However, federal regulators are gradually warming up to their potential.

In June, the Food and Drug Administration released draft guidance on how to conduct clinical trials using psychedelic drugsgiving the field a tentative nod. The agency has already approved a version of ketamine for treatment-resistant depression and granted MDMA and psilocybin breakthrough therapy status to accelerate their development. Even Congress is on board. This year, it passed bills allowing the Department of Veteran Affairs to study psychedelics for veterans mental health.

Acceptance is also growing across society. A small poll by the UC Berkeley Center for the Science of Psychedelics found over 60 percent of 1,500 surveyed participants supported legalizing psychedelics for therapy, as long as theyre regulated.

This year was a landmark year for psychedelic therapy. While promising, the results are still early. Given the drugs tumultuous history, researchers and practitioners are carefully moving forward with guidelines on best therapeutic practices (such as what to do when a patient suffers a bad trip). With at least 260 registered clinical trials in the works, next year is poised to continue psychedelic drugs foray into mental health.

Image Credit:Marcel Strau /Unsplash

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Psychedelic Drugs Are Rushing Towards Approval for Therapy. Here's What's Next - Singularity Hub

There are countless ways to acquire knowledge these days, especially when it comes to psychedelics. Tuning into a podcast or finding a righteous video to watch on YouTube often takes top billing when people are learning something new. This focus on audio-visual elements has taken center stage, but there are still avid readers who prefer to leaf through (or devour) psychedelic books.

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The psychedelic library is extensive, ranging the gamut from dry medical texts to vibrant fiction novels to poignant memoirs. There are various selections to choose from when searching for a psychedelic text to read, and some might wonder where to start. Well, thats where this list comes in. These eight psychedelic books can serve as the jumpoff for a literary psychonaut.

Those who have dipped even a toe into psychedelic counterculture have likely heard of DMT: The Spirit Molecule: A Doctors Revolutionary Research into the Biology of Near-Death and Mystical Experiences. The book offers a peek behind the curtain of psychedelic research conducted by author Dr. Strassman at the University of New Mexico. Read The Spirit Molecule or watch the documentary-style film adaptation for first-hand accounts of sixty participants who were injected with N, N-Dimethyltryptamine, or DMT.

Strassman shares theories on alien abductions, connects the substance to the pineal gland, and engages in a conversation on the souls journey in and out of the body. The trippy but scientific text is a staple on the shelves of psychonauts everywhere and serves as an excellent starting point for anyone interested in the movement.

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When speaking of the classic books on psychedelics, Food of the Gods: The Search For The Original Tree Of Knowledge always makes the list. Author Terrance McKenna is treasured in the psychedelic culture as an ethnobotanist and mystic.

Food of the Gods was the first time readers were introduced to the stoned ape theory, which posits that humans evolved into cognitive beings when Psilocybin cubensis was introduced into their diets. Many in the scientific community discredit the theory as conjecture, but it provides a solid example of what to expect from this book that views human history through a psychedelic lens.

Whether someone seeks to learn about magic mushrooms or ponder on the anthropological role of psychoactive substances in evolution, this book is for them.

One of the newer releases on the list, Exile & Ecstasy is a memoir-style exploration of the space where the psychedelic movement meets Hasidism. Journalist Madison Margolin sweeps readers through experiences growing up around HinJews, a term coined for those who practice Hinduism and Judaism.

Her world exists in the space between the Ram Dass movement and Hasidic Judaism. Sharing more about this culture opens a dialogue with the reader about spirituality, countercultures, and psychedelics as Margolin searches for her own truths on the matter.

LSD, Spirituality, and the Creative Process earns a place due to the first-hand accounts of things people see and experience while tripping on acid. The results come from one of the largest clinical studies on acid from 1954 to 1962, before it was made illegal. See real artwork, read poetry, and unlock personal reports from almost 1,000 subjects who consumed LSD-25 for the study.

Author Marlene Dobkin de Rios studied hallucinogens in indigenous societies before conducting the experiment, which aimed to examine the creative process. What becomes most striking by the end of the text is the intangible psychic links that seem to join humanity. Anyone interested in how things work will appreciate the knowledge within this psychedelic book.

Though somewhat controversial to DEA agents, every thread on psychedelic books recommends readers peruse PiHKAL: A Chemical Love Story. The text was penned by husband and wife Alex and Ann Shulgin. Alex was a chemist and pharmacologist who believed that people should have access to Phenethylamines; in fact, PiHKAL stands for Phenethylamines I have known and loved.

The first part of PiHKAL is a fictional autobiography of the Shulgins, and the second part is an extensive encyclopedia of 179 psychedelic compounds. Part two was free on Erowid, but the full two-part story is only available in the printed text. The DEA raided Shulgins lab just three years after PiHKAL was released, taking his DEA license and deeming it a cookbook for illegal drugs. The synthesis listed for MDMA, or Ecstacy, is still used by many manufacturers to this day.

We definitely dont recommend making any phenethylamines, but this book plays a part in the psychedelic history of the U.S., earning it a spot on this list.

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The authors of The Psychedelic Experience: A Manual Based on the Tibetan Book of the Dead are three heavy hitters in the American psychedelic movement. The 1964 book compares the ego death and other psychedelic experiences with the Tibetan Book of the Dead hoping to provide psychonauts with a manual to traverse the sometimes rocky landscape of a trip.

This book is a hands-on guide to navigating nuances and challenges that can emerge after consuming psychedelic substances. The book culminates in suggestions for an assisted psychedelic session from the three former Harvard researchers. Readers looking for insight into what to expect from psychedelics or curious about how the West embraced them will appreciate this book.

In the decade following his release from Harvard, Richard Alpert became Ram Dass, and the world was given Be Here Now. Spirituality, yoga, and meditation take center stage in this book that introduced many American Baby Boomers to Eastern religion.

Ram Dass created the book after being initiated into a Guru-chela relationship with Neem Karoli Baba. Though the text isnt specifically about psychedelics, the topics and imagery evoke the right mentality. Many day-trippers have spent time leafing through the pages.

Another memoir, Trip follows Tao Lin in a time of self-inflicted isolation. While Lin isolated for creative reasons he became obsessed with Terrance McKenna, researching the mystic and in turn, psychedelics and entheogens.

This book takes the reader on a cruise through the history and current understanding of psychedelics while exploring Lins own psyche. Personal tales of recovering from pharmaceutical drugs while experimenting with substances like DMT and psilocybin juxtapose philosophical quandaries regarding the purpose of art and more. This is a journalistic look at the internal psychedelic revolution many individuals might have experienced.

These are the top eight psychedelic books for anyone with an interest in the history of these substances or trying them. From memoirs to manuals to historical texts, these books cover it all. Read them all already? Not to worry, theres always new editions like Welcome to Psilocybin and many unlisted classics like Doors of Perception by Aldous Huxley. There are tons more fantastic psychedelic books, these are just the staples.

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The top 8 psychedelic books you need to read | GreenState - GreenState

MAPS Public Benefit Corp. closed a $100 million Series A funding round and rebranded as Lykos Therapeutics, the company announced Thursday.

The funding, which will support the companys development of MDMA-assisted therapy for post-traumatic stress disorder, comes from a range of new investors, alongside the conversion of an undisclosed sum of convertible notes issued earlier.

Originally a subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS), a nonprofit research organization, the rebranding and new funding represent a shift towards a more commercial focus. The company has been preparing for the potential market launch of its MDMA-assisted therapy for PTSD, pending FDA approval.

The financing round was led by Helena, a self-described decentralized global problem solving organization focused on identifying solutions to critical global problems and directly implement them through individual projects.

We are incredibly grateful for Helenas tremendous support and leadership as well as the contributions from other mission-aligned investors, which comes at this critical time as we are transitioning from a development-stage company to one focused on commercialization of the potential first psychedelic-assisted therapy, Lykos CEO Amy Emerson said in a statement.

According to the announcement, other contributions streamed from a variety of investors, including:

In a separate memo, Emerson wrote, We selected a new name, Lykos or wolf in Greek, to represent the qualities bravery, courage, loyalty and intelligence that resonate with our company. Along with the name change, the new visual identity represents the overlap of innovative science combined with focus on the whole person.

MAPS retains significant control over the company and the appointment six of the eight members of Lykos board of directors.

The capital raised in this round is earmarked for regulatory and pre-launch activities for MDMA-assisted therapy, which is currently undergoing the process for FDA approval. Lykos said it wants to make this therapy available for prescription use in treating PTSD after approval.

MAPS, alongside its work with Lykos, said it would continue to engage in other psychedelic research initiatives, drug policy reform, and cultural development regarding the use of psychedelics and cannabis for therapeutic purposes.

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Lykos Therapeutics Secures $100M in Series A Funding, Rebrands from MAPS PBC - Green Market Report

The Drug Enforcement Administration (DEA) is now calling for the production of even more THC, psilocybin and DMT for research purposes than it initially proposed for 2024raising its quotas for those drugs while maintaining already high production goals for marijuana and other psychedelics.

In a notice set to be published in the Federal Register on Wednesday, DEA said it received comments from registered manufacturers requesting increases to previously proposed 2024 quotas for the Schedule I substances in order to meet medical and scientific needs, and it agreed to do so in the new final order.

Accordingly, the agency nearly doubled the quotas for delta-9 THC and all other tetrahydrocannabinol, increasing them to 1,523,040 grams and 1,166,130 grams, respectively.

DEA is also calling for 20,000 grams of psilocybin (up from an initially proposed 15,000 grams) and 11,000 grams of DMT (up from 3,000 grams).

The production goals for marijuana and various other psychedelic compounds were kept the same as they were first proposed in November: 6,675,000 grams of marijuana, 1,000,000 grams of marijuana extract, 24,000 grams of psilocyn, 150 grams of ibogaine, 12,000 grams of MDMA, 1,200 grams of mescaline, 11,000 grams of 5-MeO-DMT and 12,000 grams of MDA.

The quotas for those substances are largely consistent with DEAs 2023 production levels, though the agency has generally been authorizing higher amounts year-over-year as interest in the therapeutic potential of cannabis and psychedelics continues to grow.

Thats been especially true of psychedelics in more recent years, coinciding with historic local, state and federal reforms to decriminalize entheogenic plants and fungi while promoting scientific research and therapeutic access.

For example, DEAs 2020 quota for psilocybin was 30 grams, compared to 20,000 grams in its latest proposal.

There has been a significant increase in the use of schedule I hallucinogenic controlled substances for research and clinical trial purposes, the agencys earlier notice from November said. DEA has received and subsequently approved new registration applications for schedule I researchers and new applications for registration from manufacturers to grow, synthesize, extract, and prepare dosage forms containing specific schedule I hallucinogenic substances for research and clinical trial purposes.

In the new document, DEA also responded to comments requesting increases to psychedelic production quotas for religious use and expressing frustration that the agency has disregarded their legal religious use of psychedelics as a factor when setting the production quotas of these substances.

The commenters asked for a hearing with the DEA administrator to discuss the issue, but the agency did not directly address that request.

Instead, it pointed out that DEA has previously held discussions with representatives of indigenous communities when requested and continued to welcome further engagement and input, adding that production quotas are determined in part by the individual manufacturing quota requests submitted by DEA-registered manufacturers of these substances.

Another pair of comments recommended that the agency include fruiting bodies containing psilocybin and psilocin and peyote buttons containing mescaline, rather than pure chemicals only in its production quotas.

DEA responded that, because the Controlled Substances Act (CSA) has specific control over psilocybin and psilocyn, rather than the mushrooms containing those compounds, it will continue to set quotas based on those individual constituents, both synthetically and naturally derived. It said that peyote is also scheduled separately from mescaline, and the quota does not call for the production of the cacti.

Meanwhile, in 2022, DEA finally ended a longstanding monopoly on marijuana manufacturing for research purposes domestically that could presumably help meet the higher production quotas. Additionally, the agency has discussed its work to implement rules to streamline cannabis access for scientists following the enactment of a cannabis research bill in 2022.

The finalized 2024 quotas come in the context of an ongoing administrative review into the scheduling status of cannabis that DEA is actively carrying after receiving a recommendation from the U.S. Department of Health and Human Services (HHS) to move marijuana from Schedule I to Schedule III under the CSA.

It also comes as the Food and Drug Administration (FDA) considers an application to authorize the use of MDMA as a prescription medication for post-traumatic stress disorder (PTSD) in light of clinical trials demonstrating its therapeutic efficacy.

DEA has touted its Schedule I drug production quotas as evidence that is supports rigorous research into the substances, but its faced criticism from advocates and scientists over actions that are viewed as antithetical to promoting studies.

For example, DEA recently announced that it is taking another shot atbanning two psychedelics after abandoning its original scheduling proposal in 2022, teeing up another fight with researchers and advocates who say the compounds hold therapeutic potential.

The agency separately backed down from a proposal to ban five different tryptamine psychedelics in 2022amid sizable pushback from the research and advocacy communities.

Meanwhile, a federal appellate panel has denied a motion by lawyers fora Washington State doctor trying to reschedule psilocybin under the CSA. In an order last month, a three-judge panel of the U.S. Court of Appeals for the Ninth Circuit rejected the doctors request for a rehearing of an earlier court decision that returned the matter to DEA.

DEA is separatelywarning Georgia pharmacies that dispensing THC is unlawfulbecause it remains a Schedule I drug after the state became the first in the U.S. to allow pharmacies to sell medical marijuana, with nearly 120 facilities applying to sell cannabis oil.

Colorado Governor And Activists Celebrate 10-Year Anniversary Of First Legal Recreational Marijuana Sales

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DEA Calls For Even More THC, Psilocybin And DMT To Be Produced For Research In 2024 - Marijuana Moment