Daily Archives: October 5, 2020

Posters highlight improvements in respiratory safety and gastrointestinal tolerability associated with OLINVYK (oliceridine) injection vs. IV morphinel

CHESTERBROOK, Pa., Oct. 05, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced three presentations at ANESTHESIOLOGY 2020, the national conference for the American Society of Anesthesiologists (ASA). The conference was held virtually from October 2nd to 7th, 2020. The presentations included three posters, all of which discussed new analyses of data from the OLINVYK Phase 3 program.

Throughout its clinical development, OLINVYK has demonstrated a consistently favorable side effect profile, said Mark Demitrack, M.D., Senior Vice President and Chief Medical Officer of Trevena, Inc. I am pleased that we are still gaining valuable clinical insights into its differentiated profile as we continue to examine the robust Phase 3 data, which is clearly of great interest to clinicians looking for alternative treatment options for the treatment of acute pain.

Poster Details

1. (Poster #A4280) Evaluating Predictive Value Of Postoperative O2 Saturation Levels To Rate Of Respiratory Safety Events In Oliceridine Trials, with lead author Sabry Ayad, M.D., Department of Anesthesiology at Cleveland Clinic.

2. (Poster #A4281) Improved Tolerability With Oliceridine Compared To Morphine At Equianalgesic Doses, with lead author Gregory Hammer, M.D., Professor of Anesthesiology, Perioperative and Pain Medicine, and of Pediatrics at Stanford University.

A secondary analysis was conducted on the data from the OLINVYK Phase 3 pivotal RCTs in order to evaluate the safety of OLINVYK, compared to IV morphine, when adjusted for equal levels of analgesia. A composite safety endpoint was defined using the adverse events (AEs) that occurred in 10% of patients who received either OLINVYK or IV morphine (nausea, vomiting, sedation, dizziness, pruritus, and hypoxia). The incidence of the individual AEs was also assessed.

3. (Poster #A4284) Reduced Incidence Of Postoperative Vomiting With Oliceridine Than Morphine At Equianalgesic Doses, with lead author Tim Beard, M.D., Chair of the Department of Surgery at Summit Medical Group.

A retrospective analysis was conducted on the gastrointestinal (GI) tolerability data from the OLINVYK Phase 3 RCTs, using a complete GI response endpoint. A complete GI response is defined as the proportion of patients who complete the study without vomiting and without using any anti-emetics.

All posters can be found at https://www.trevena.com/publications.

About OLINVYK (oliceridine) injection

OLINVYK is a new chemical entity approved by the FDA in August 2020. It is indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. OLINVYK will not be available for distribution until the United States Drug Enforcement Administration assigns it to its schedule of controlled substances. Please see Important Safety Information, including the BOXED WARNING, and full prescribing information at http://www.OLINVYK.com.

About Trevena

Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with CNS disorders. The Company has one approved product in the United States, OLINVYK (oliceridine) injection, indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. The Company also has four novel and differentiated investigational drug candidates: TRV250 for the acute treatment of migraine, TRV734 for maintenance treatment of opioid use disorder, and TRV027 for acute lung injury / abnormal blood clotting in COVID-19 patients. The Company has also identified TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to treating a variety of CNS disorders.

For more information, please visit http://www.Trevena.com

Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Companys strategy, future operations, clinical development and trials of its therapeutic candidates, plans for potential future product candidates, commercialization of approved drug products and other statements containing the words anticipate, believe, estimate, expect, intend, may, might, plan, objective, predict, project, suggest, target, potential, will, would, could, should, continue, ongoing, or the negative of these terms or similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the commercialization of any approved drug product, the status, timing, costs, results and interpretation of the Companys clinical trials or any future trials of any of the Companys investigational drug candidates; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including the Companys assessment of the discussions with the FDA or other regulatory agencies about any and all of its programs; uncertainties related to the commercialization of OLINVYK; available funding; uncertainties related to the Companys intellectual property; uncertainties related to the ongoing COVID-19 pandemic, other matters that could affect the availability or commercial potential of the Companys therapeutic candidates; and other factors discussed in the Risk Factors set forth in the Companys Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Companys views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Companys views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.

For more information, please contact:

Investor Contact:

Dan FerryManaging DirectorLifeSci Advisors, LLCdaniel@lifesciadvisors.com(617) 430-7576

Company Contact:

Bob YoderSVP and Chief Business OfficerTrevena, Inc.(610) 354-8840

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Trevena, Inc. Announces Three OLINVYK Presentations at the Virtual American Society of Anesthesiologists 2020 Annual Meeting - BioSpace

Headache may be one of the most recognizable health concerns, but managing it may not always be clear. A presentation at the virtual 2020 American Academy of Pediatrics National Conference & Exhibition offers a tiered approach to aid in management.

Its not an uncommon diagnosis. In fact, its the number 1 pediatric neurologic reasonfor going to the doctor for a visit, utilizing either urgent care or the emergency department, and for referral to pediatric neurology. The headache is also responsible for roughly 200,000 missed days of school per year in the United States. Managing headaches can require deft handlingand Christopher B Oakley, MD, assistant professor of neurology at Johns Hopkins Medicine in Baltimore, Maryland, offered an approach to follow in his presentation Heads up: Headache management in primary care at the virtual 2020 American Academy of Pediatrics National Conference & Exhibition.

Oakley offered a 4 tier approach to headache management. In the first tier, the clinician should address the lifestyle of the patient who is presenting with headache. Questions about day-to-day activities mayinclude asking whether the child is achieving adequate sleep duration, finding out how much caffeine the child is ingesting, inquiring after the level of hydration, as many children are often not getting the necessary intake of water, whether the child is getting enough physical activity in a week, and discovering how busy the child is. The second tier looks at whether complementary and alternative medicines or therapy can help treat the problem. This tier may include having the child participate in cognitive behavioral therapy, use supplements as CoQ10, or utilize physical therapy. The third tier involves prescribing prophylactic medications such as amitriptyline and topiramate and the fourth tier includes hormonal therapies and procedures such as nerve blocks.

He also addressed how the COVID-19 pandemic may have altered the incidence of headaches as well as treatment. He highlighted how the pandemic has increased stressors because of changes in family dynamics along with increased social isolation. Virtual learning also led to different experiences such as lower educational quality, lack of extracurricular activities, increased screen time, and a feeling of separationfrom peers. Oakley used the case of a 16-year-old girl to illustrate the impact. She had increased migraines since the start of the pandemic; hadnt seen her psychologist or physical therapist since before the pandemic began, did not do well with the lack of structure inherent to virtual learning, and was anxious because of familial concerns.

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Managing headache with a tiered approach - Contemporary Pediatrics

On most days of the week, whether its at school or at work, life can be quite stressful. The traffic is either terrible or there are too many assignments, whatever the reason, stress, and anxiety loom over us. Anxiety can either be chronic or happen every once in a while, but either way, it is a terrible feeling that stops us from getting through the day successfully. Many people feel anxious about the past or upcoming events and opt for medication, such as antidepressants. These have different effects on each person and they always have some sort of side effect.

Read on to learn about alternative ways to calm yourself without taking medicine.

Exercise releases endorphins, which are part of the happy chemicals that your body produces. This can make you less anxious and help you sleep much better at night. You may be energetic after working out or during your workout, but as the day passes, you will find yourself tired at night and unable to hold your phone. If you make it a point to exercise on a regular basis, this will do wonders in calming your mind and helping you stay focused as well.

For someone who has anxiety or is quickly triggered, caffeine is not good news. Given that caffeine is a stimulant, it can get you hyped up and overly energetic. Caffeine can prompt the fight or flight response which makes anxiety much worse. Instead, you can opt for decaf coffee, herbal tea, ginger tea, dandy blend, or kratom tea from a trustedwebsite if you enjoy hot drinks. Doing your research will give you the best drinks to alleviate your anxiety. Caffeine is also found in chocolate, so unless you enjoy imitation chocolate made from soy, try to limit your chocolate intake.

Anxiety can causesleeping disorders and lack of sleep can cause anxiety. This is a tedious loop that can keep you anxious and tired for weeks on end. After exercising or doing a bunch of activities, try to sleep for about 7-9 hours in order to wake up calm and ready to tackle your day. Studies show that while you sleep, your mind organizes your thoughts and allows you to think clearly. Therefore, if you are constantly worried about something, a good nights sleep will help you sort it out and find solutions for the issue.

It is rare to find a yogi who is stressed. Yoga and meditation are two of the ways that can definitely reduce stress and keep you calm. The act of yoga and meditation allows you to work on your mindfulness, which helps you think about the here and now rather than focusing on the past or future issues.

We often have so many thoughts in our heads and our mind exaggerates issues that can be fixed in no time. You can write down these thoughts and get them off your chest to feel less burdened. Also, if you happen to feel as though you have a lot to do, write down the tasks and divide them according to accessibility and find out which will be the quickest to finish. Completing any task will give you peace of mind and a sense of accomplishment.

One of the best ways to treat yourself and be calm is by going to a spa. A good hour-long massage will loosen up your muscles and help you to feel super relaxed- which will certainly help you sleep. Studies also show that the heat from the sauna can make you feel calmer, as you are focused on the here and now rather than focusing on whatever it is that is making you anxious or stressed.

As clich as this sounds, the fastest way to calm down is to take deep breaths. Those who are hyperventilating breathe in and out of a bag to help them slow down a little and get their thoughts in order. Take the time to breathe. If you are stressed about work, breathe in and out and go to your happy place. Your happy place could be a time you went to the beach, hanging out with family, or even that 5 pm on a Friday afternoon when you are done with work for the week. No matter what it is, think about it and breathe deeply in and out and you will find yourself calmer in no time.

Although medication is the easiest way out, it can be problematic. The side effects of medication on each individual differs and you never know how it might affect you. Try the tips provided here in whichever order you want, but be sure that you go through each one and give them a chance before visiting a doctor to prescribe something. The main step you should take is to determine what the stressor is and take the time to tackle it rather than try to avoid the issue altogether.

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Alternative Ways To Calm Yourself Without Taking Medicine - KHTS Radio

This story is part of a series of profiles, The CannaInfluencers: The people shaping the cannabis industry in the Garden State. Written by NJ Cannabis Insider reporters, the profiles will publish the weeks leading up to the Nov. 3 election, when New Jersey voters will decide whether to legalize recreational, adult-use cannabis.

One of the ironies of the ruthless and litigious marijuana industry is that it bears no resemblance to the delicate cannabis plant, heralded for its pain-relieving, muscle-relaxing and calming properties.

Even in this inhospitable environment, patients, lawmakers, license holders, and even some critics agree that Jeff Brown has thrived.

While the number of cannabis companies cannot expand beyond the current nine (with a total of 12 retail locations) because of the pending lawsuits challenging the health departments choice of applicants, Brown has presided over a medicinal marijuana program that has seen tremendous growth. Registered patients have swelled from nearly 19,000 to 90,000 patients since his arrival in April 2018. As an assistant health commissioner, he has implemented changes some enacted by the governor and state Legislature, some pandemic-driven that have enabled patients to buy their medicine safely and with fewer bureaucratic hoops to clear.

His fans include the co-founder of the Coalition for Medical Marijuana-New Jersey, a patient and advocate group that has been critical of the program.

I am very grateful for Jeff Browns willingness to meet with us, the CMMNJ Board members, to listen to us, and to address many of our concerns, said Ken Wolski, who is also a nurse and a registered patient.

Jeff even reached out to me, unsolicited, on a couple of occasions for my input on issues such as THC concentration in medical products, Wolski said.

Cannabis attorney Bill Caruso said Brown keeps the patients perspective close at hand in whatever hes doing, such as his decision to expedite the registration process for terminally ill patients.

He has done a fantastic job under extraordinary statutory and regulatory hurdles and delivering for patients, Caruso said. Having the right person at the top matters.

Brown describes the job as frequently rewarding and at times incredibly frustrating.

Some days, Brown fields calls from aggrieved parties who are fighting for a piece of the medicinal cannabis market, and from the lawmakers who represent them. Other days, he and his staff are getting an earful from patients frustrated they have to drive so far and pay so much for their medicine.

Observing the national cannabis market, Brown said many states are sued by entrepreneurs who dont get picked as the licensed growers and sellers. An average of 10% of unsuccessful applicants sue, he said. Its the cost of doing business.

There are so many people that want to get into the market and that makes for very hairy politics, Brown said. It has required a lot of focus on policy and politics. In everything I am doing, I try to bring it back to the patients.

The 38-year-old Rutgers University graduate and Mercer County resident may be one of the few whose primary focus is on the 10-year-old medical marijuana law at the moment. New Jersey voters will decide on Nov. 3 whether adults 21 and older should be permitted to buy marijuana taxed and sold by state-approved cultivators.

In some states, the medical market has withered after legalization. Brown said he wont let that happen.

The current medical marijuana operators, known as alternative treatment centers in New Jersey, presumably have an advantage because they are growing cannabis legally. But Brown said the state would prevent any medical provider from entering the adult market until they can demonstrate they can set aside an adequate supply for their patients.

The industrys track record on keeping up with demand has been disappointing, Brown said.

One of the things I have learned is that we are talking about a medical product and medical market but its very much driven by the laws of economics. Sitting as a regulator, I dont make laws and I cant make private industries do things, Brown said.

There are people all over the state who need access. I would really love to see the market expand, he said.

Before joining the Murphy administration, Brown held health policy jobs that focused on impoverished people and their struggle getting medical care. In one job, with the New Jersey Health Care Quality Institute, he oversaw a project to improve the Medicaid payment system. He said it surprised him to learn 60% of registered patients qualify for reduced registration fees because they have such a limited income.

This is very much the similar group of citizens I was focused on in my previous jobs, he said.

Brown came into an office hamstrung by Gov. Chris Christie, who made it clear he resented inheriting and implementing a law he didnt support. But he found 22 employees who were enthusiastic and eager to improve, Brown said. He recalled Sue Carson, the program director who has since retired, suggested making a fairly simple information technology switch that would make the patient registry available on mobile phones. It took all of one day to complete, he said.

Shortly thereafter, people could take photos of their documents at home. People were going to public libraries to do this, he said.

Brown is doing exactly what he was hired to do, Murphy said.

After eight years of stonewalling by the previous administration, in one of my first executive actions I ordered a sweeping review of New Jerseys medicinal marijuana program and appointed Jeff Brown to head the Division of Medicinal Marijuana. Under Jeffs leadership, the program has been overhauled with a compassionate, patient-centered approach that has increased the number of qualifying conditions, removed needless barriers, and expanded dispensaries across the state, Murphy said in a statement to NJ Cannabis Insider. I cant thank Jeff and his team at the Department of Health enough for their efforts to deliver sustainable, affordable access to this life-changing medical treatment for more than 90,000 patients in New Jersey a fivefold increase from when we took office.

Brown taking a selfie with his wife, Lindsey, on a vacation in Italy.

While Brown has been busy expanding the program, he and his wife, Lindsey, a physical therapist, have expanded their family. Their oldest daughter, Madison, will turn 3 in October; Sadie was born last month. Brown said he likes to travel and is a record collector, with 50s and 60s jazz performers his favorite. But the pandemic hasnt left much time for after-hours pursuits. Health Commissioner Judy Persichilli dispatched him to oversee the opening of the field hospital in Atlantic City when the coronavirus outbreak was at its height in the spring.

Presuming the polls are correct and voters approve the constitutional amendment legalizing marijuana, insiders speculate the Murphy administration will give Brown a prominent role in the cannabis regulatory commission that will regulate both the adult and medical markets. Brown said he hasnt been approached.

For now, hes focused on launching a home delivery program and finding ways to simplify the registration and renewal process for patients.

I ground myself by remembering its not about me, its not about the industry, its about them, the patients.

Industry insiders speculate Brown will have a prominent role in the cannabis regulatory commission that will regulate both the recreational and medical marijuana markets.Phil McAuliffe For The Times Of Trenton

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Susan K. Livio may be reached at slivio@njadvancemedia.com. Follow her on Twitter @SusanKLivio.

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Cannabis influencers: Hes the right person at the top delivering for N.J. patients - NJ.com

Alternative Medicines and Therapies Comprehensive Study by Type (Mud Therapy, Reiki, Oil Massage Therapy, Magnetic Therapy, Some Breathing Exercises, Meditation, Yoga, Osteopathic Manipulation), Application (Hospital , Clinic), Distribution Channel (Direct Sales, E-Sales, Distance Correspondence) Players and Region - Global Market Outlook to 2025

COVID-19 Outbreak- Alternative Medicines and Therapies Market Research Study The exploration report comprised with market data derived from primary as well as secondary research techniques. The solicitation of proposals by the governments and publicprivate companies across the world to mitigate the impact of the COVID-19 pandemic is considered to be market forces.

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Reddy's Laboratories (India), Wright Health Group Ltd. (United Kingdom), Nordic Nutraceuticals (Denmark) and Pure encapsulations, LLC (United States)

Alternative medicine and therapies refer to any health treatment not standard in Western medical practice. It is referred to as complementary medicine.

Its aims to achieve the healing effects of medicine, but which lacks biological plausibility and is untested, untestable or proven ineffective.

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Market Drivers

Market Trend

Restraints

Opportunities

Challenges

Market Competition

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COVID-19 Outbreak- Alternative Medicines and Therapies Market Geographical Segment North America (Canada, United States & Mexico) Europe (Germany, the United Kingdom, Belgium, Netherlands, France, Russia & Italy, Others) Asia-Pacific (Japan, South Korea, China, India & Southeast Asia) South America (Argentina, Brazil, Peru, Colombia, Etc.) Middle East & Africa (United Arab Emirates, Egypt, Saudi Arabia, Nigeria & South Africa)

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The titled segments and sub-section of the market are illuminated below:

Type (Mud Therapy, Reiki, Oil Massage Therapy, Magnetic Therapy, Some Breathing Exercises, Meditation, Yoga, Osteopathic Manipulation), Application (Hospital, Clinic), Distribution Channel (Direct Sales, E-Sales, Distance Correspondence)

Business StrategiesKey strategies in theCOVID-19 Outbreak-Global Alternative Medicines and Therapies Market that includes product developments, partnerships, mergers and acquisitions, etc discussed in this report. The worth of strategic analysis has been rigorously investigated in conjunction with undisputed market challenges.

Type 1 of COVID-19 Outbreak- Alternative Medicines and Therapies market is expected to the dominate the overall market during the forecast period till 2026. The market will boost by application XX to improve operations efficiently and with minimum operational cost.

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Chapter 1: Introduction, market driving force product Objective of Study and Research Scope the Alternative Medicines and Therapies market

Chapter 2: Exclusive Summary the basic information of the Alternative Medicines and Therapies Market.

Chapter 3: Displayingthe Market Dynamics- Drivers, Trends and Challenges&Opportunities of the Alternative Medicines and Therapies

Chapter 4: Presenting the Alternative Medicines and Therapies Market Factor Analysis, Post COVID Impact Analysis, Porters Five Forces, Supply/Value Chain, PESTEL analysis, Market Entropy, Patent/Trademark Analysis.

Chapter 5: Displaying the by Type, End User and Region/Country 2014-2019

Chapter 6: Evaluating the leading manufacturers of the Alternative Medicines and Therapies market which consists of its Competitive Landscape, Peer Group Analysis, BCG Matrix & Company Profile

Chapter 7: To evaluate the market by segments, by countries and by Manufacturers/Company with revenue share and sales by key countries in these various regions (2020-2025)

Chapter 8 & 9: Displaying the Appendix, Methodology and Data Source

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Alternative Medicines and Therapies Market Emerging Trends and Strong Application Scope by 2025 | Weleda, Cipla, Sante Verte Lab, Sandoz International...