MDMA Archives - Green Market Report

Adam JacksonSeptember 15, 2022
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3min1510

Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) posted positive results as revenue rose along with patients — showing the growing demand for psychedelics-centered therapy to treat addictions. The Canadian biotechnology company released its financial report card for the second quarter ending July 31.

Awakn posted revenues of C$339,872 via Awakn’s clinics for the second quarter, versus no revenue in the prior year. The second quarter revenue is up C$86,718, or 34% over the quarter.

The company said that revenue “during the seasonally quietest period of the year for our services” was primarily driven by the provision of ketamine-assisted therapies at the London, Bristol and Oslo Awakn clinics. These clinics were not open during the equivalent period last year.

“Today’s results and revenue growth demonstrate the continued momentum building in our business and the successful execution of our business plan in both pillars of the business: R&D and Commercialization,” CEO Anthony Tennyson said.

Over the quarter, Awakn received approval for its Phase III clinical trial for ketamine-assisted therapy for the treatment of Alcohol Use Disorder. This is the first time a government agency has funded a Phase III trial in psychedelics.

The company received C$2.5 million from U.K.’s National Institute for Heal and Care Research to cover 66% of the costs of the trial. The company will bankroll the rest.

“We have also made excellent progress in strengthening the IP moats for our ketamine and MDMA programs,” Tennyson said, referring to the competitive advantage of its intellectual property.

The company had C$481,830 in cash. It also announced the closing of a private placement – issued 1,880,454 units at a price of C$0.55 per unit raising gross proceeds of C$1,034,250.

“We have also successfully launched our licensing partnership business into the U.S. and Canada, putting us in the unique position of being a biotech with commercial operations in four territories, the U.K., the U.S., Canada and Norway, in only our second full financial year,” Tennyson said

Through the rest of the fiscal year, Awakn said it anticipates receiving regulatory and ethics approval for its Phase III clinical trial for ketamine-assisted therapy, as well as completing its behavioral study of ketamine in gambling addiction.

The company will also look to further its therapeutics commercialization through acquiring more licensing partners utilizing the company’s intellectual property moat ketamine-assisted therapy for treatment of Alcohol Use Disorder in the U.S. and Canada.


Dave HodesMay 6, 2022
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9min3660

MDMA, or methylenedioxymethamphetamine, has become more of a psychedelics wonder drug today, distancing itself as the rave party fuel (ecstasy or Molly) that it was in the 1980s and being positioned as the wonder drug that psychedelics researchers have hoped for.

Researchers have discovered that MDMA, with structural similarities to both mescaline and methamphetamine, can help with post traumatic stress disorder. MDMA can also help with autism. Anorexia nervosa. Social anxiety. Drug addiction. Alcoholism. Diabetes. Chronic pain. Fibromyalgia. Rheumatoid arthritis. Parkinson’s disease. Even hangovers.

There are 69 MDMA studies either completed or ready to begin in the U.S., Switzerland, Spain, the Netherlands, Canada, the UK, Germany, and Israel. Nearly half are for PTSD. 

All this encouraging treatment news comes from a substance patented over 100 years ago by the pharmaceutical giant Merck in 1914. MDMA was found to have an onset of 30-45 minutes, and create a two to four hour experience characterized by euphoria, increased well-being, sociability, self-confidence, and extroversion.

Psychiatrists used MDMA briefly in the 1970s and 1980s before it ended up as a party drug.

As a result of the use of MDMA being overused in raves and causing deaths and injuries, the Drug Enforcement Administration (DEA) declared an emergency ban in 1985 and listed it as a Schedule 1 drug

But that did little to slow down the progress of its development. In the early 1990s, the FDA approved the first human trial exploring whether MDMA could help relieve pain in terminally ill patients, as well as serve as an adjunct to psychotherapy.

Then MDMA began inching its way up the list of substances to study with psychedelics researchers when, in 1998, research with humans began in earnest at the UCLA Medical Center. More interest was generated in 2011, with the results of the first randomized controlled pilot study into MDMA for PTSD.

In 2017, the FDA granted breakthrough therapy designation for MDMA to the Multidisciplinary Association for Psychedelic Studies (MAPS), an organization intent on driving further development.

In 2020, a MAPS phase 3 clinical MDMA trial was successful, and a second phase 3 trial is currently underway supported by $30 million in funding. “It’s only now in 2020 that we have been able to generate evidence supporting safety and efficacy in the context of an FDA-regulated Phase 3 clinical trial,” Rick Doblin, founder and executive director of MAPS, wrote in a MAPS bulletin after the first clinical trial. “Our current timetable for the potential of FDA approval is the first half of 2023, 37 years after the DEA kept both the therapeutic and social use of MDMA illegal.”

MAPS has also developed the first validated commercial synthetic process for producing multi-kilogram batches of MDMA under current Good Manufacturing Practices, making larger quantities of MDMA available to help with ongoing clinical trials and provide for future therapeutic use.

MDMA’s moment in the limelight will continue growing, as the need for any help with PTSD expands nearly daily. The MAPS clinical trial researchers noted that the timing is right for MDMA. “We may soon be confronted with the potentially enormous economic and social repercussions of PTSD, exacerbated by the COVID-19 pandemic. Overwhelmingly high rates of psychological and mental health impairment could be with us for years to come and are likely to impart a considerable emotional and economic burden. Novel PTSD therapeutics are desperately needed, especially for those for whom comorbidities confer treatment resistance.

“Not only is MDMA-assisted therapy efficacious in individuals with severe PTSD, but it may also provide improved patient safety. Compared with current first-line pharmacological and behavioral therapies, MDMA-assisted therapy has the potential to dramatically transform treatment for PTSD and should be expeditiously evaluated for clinical use.”


Dave HodesApril 14, 2022
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9min1110

Public funding for new mental health discoveries that can change the lives of millions of Americans for good? In a word: Absolutely.

Over the last three years, clinical trials of psilocybin and MDMA psychedelics assisted therapy in particular have demonstrated their value in treating various mental health conditions, even hard to treat conditions such as so-called treatment resistant depression. It is believed that this new therapy offers real hope for the hopeless.

The clinical trials excitement is tempered by the fact that there are still many answers needed about how various psychedelic substances work inside the human brain. There is so much more work to do. But that is precisely why more public funding is needed.

To be sure, hundreds of millions of dollars in philanthropic investment are actively making a difference. One example: Stephen Jurvetson, co-founder of Future Ventures and a board member at  SpaceX, is reportedly giving about half of his net worth to fund psychedelic science.

Nonprofit Research

The Psychedelic Science Funders Collaborative (PSFC), a nonprofit organization founded in 2017 created to support scientists and organizations working on psychedelic clinical trials, includes some of the leading funders of psychedelic medicine who are supporting organizations at the cutting edge of psychedelic research. PSFC has funded several organizations at the forefront of the psychedelic field, and, in 2020, completed a $30 million fundraising campaign in partnership with the Multidisciplinary Association for Psychedelic Studies (MAPS) to support the completion of phase 3 clinical trials of MDMA-assisted psychotherapy. 

PSFC’s current areas of focus includes supporting broad and equitable access to high-quality MDMA-assisted psychotherapy post-FDA approval, and supporting the implementation of Oregon’s Measure 109.

It seems that almost every week, another business leader or philanthropist steps up with a psychedelics funding objective—SpaceX founder Elon Musk, Groupon co-founder Andrew Mason, even an anonymous Bitcoin millionaire. But it’s not enough. Deeper pockets are needed for more historic and life-changing outcomes that psychedelics research has just begun to deliver.

A primary source of federal medical science funding comes from the National Institutes of Health (NIH). NIH-funded research has contributed to a 60 percent reduction in the death rates for coronary heart disease and stroke, a 40 percent decline in infant mortality over the past 20 years, and a 30 percent decrease in chronic disability among seniors.

Psychedelics research is at a point where it is ripe for more government funding, as a growing number of U.S. cities and states are taking legislative action to decriminalize or legalize psychedelic use and/or research; and a new Harris Poll reporting that nearly two thirds of Americans who suffer from anxiety/depression/PTSD believe that psychedelic medicine should be made available to patients with treatment-resistant anxiety, depression or PTSD.

Government Funding

And then: The DEA stepped up its allowable production quotas for psychedelics in November citing “a significant increase in the use of schedule I hallucinogenic controlled substances for research and clinical trial purposes.”

There has been a glimmer of hope for public funding in psychedelics. In October, Johns Hopkins Medicine was awarded a grant from the NIH to explore the potential impacts of psilocybin on tobacco addiction. This is the first NIH grant awarded in over a half century to directly investigate the therapeutic effects of a classic psychedelic.

With that announcement comes reference to the stigma problem that began when studies on LSD and other psychedelics that were raging over 50 years ago, in the 1960s and 1970s. LSD became a victim of a politized youth culture at the time that turned the potential therapeutic good of LSD into just another party drug problem. It was made illegal by the DEA as a Schedule 1 drug. Recovering from over 50 years of public disparity has been achieved somewhat, but it is still an ongoing issue with not just LSD but all psychedelics.

It’s clear that today, the NIH needs to get into the psychedelics game in an even bigger way than just its recent grant to Johns Hopkins. The limited support from philanthropic sources has funded the research so far, but these are restricted trials of relatively small samples of patients because of the cost of doing larger studies.

By contrast, NIH is the largest single public funder of biomedical research in the world. Every state and almost every Congressional district has earned a share of this investment. NIH investments in research focused on a particular area has been found to stimulate increased private investment in the same area. A $1.00 increase in public basic research stimulates an additional $8.38 of industry R&D investment after 8 years. A $1.00 increase in public clinical research stimulates an additional $2.35 of industry R&D investment after 3 years.


Julie AitchesonMay 5, 2021
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5min2430

The Multidisciplinary Association of Psychedelic Studies (MAPS) has worked for the last 35 years to shift the perception around psychedelics as a treatment tool for mental health issues. Now, with the release of data from its Phase III trial with the FDA for the use of MDMA (ecstasy) to treat PTSD, MAPS’ work has coalesced into findings that could change the mental health treatment landscape as we know it. 

MDMA is on the cusp of FDA approval to treat PTSD, not just for military veterans, but for an array of people who have suffered from abuse and other trauma-inducing events. In 2017, the FDA granted MDMA “breakthrough therapy status” in anticipation of approving it as a medication for mental health, and the release of MAPS’ latest statistically significant findings constitutes a huge leap towards legalization. 

The conversation around the legalization of psychedelic drugs is not new to the mental health community. Trials testing the efficacy of psychedelics such as LSD for mental illness began as early as the 1950s. By the 1960s more than 1,000 papers had been published about LSD as a treatment for depression, alcoholism, schizophrenia, and as an adjunct to psychotherapy. These trials lacked the scientific rigor necessary for legitimacy in the eyes of the FDA, but due in no small part to the work of MAPS, legitimacy is no longer the stumbling block it once was.

 MDMA showed efficacy for treating PTSD in six MAPS Phase II trials, providing a cost-saving and clinically beneficial treatment for those with severe or extreme chronic PTSD resulting from any cause. The Phase III trial is the first of any psychedelic-assisted therapy. It was a randomized, blinded study designed under an FDA-approved Special Protocol Assessment. 90 patients with severe, chronic PTSD were enrolled in the trial and randomized to receive either MDMA or a placebo. The results, according to the lead author of the paper, Jennifer Mitchell, Ph.D., were significant. “People with the most difficult-to-treat diagnosis, often considered intractable, respond just as well to this novel treatment as other participants. In fact, participants diagnosed with the dissociative type of PTSD experienced a greater reduction in symptoms than those without the dissociative subtype.”

The Phase III trial data revealed that 67% of the group who received MDMA no longer qualified for a PTSD diagnosis after three treatment sessions (compared to 32% of the placebo group). 88% of participants in the MDMA sessions experienced a clinically significant reduction in symptoms, as opposed to 60% of the placebo group who received therapy alone. Mitchell attributes MDMA’s effectiveness to its role as a catalyst in therapy, which often involves recalling, and frequently reactivating, previous trauma. “The unique ability of MDMA to raise compassion and understanding while tamping down fear is likely what enables it to be so effective.”

Researchers are currently enrolling participants in a second Phase III trial and MAPS is formulating plans for additional studies to evaluate MDMA’s efficacy for mental health conditions not yet explored, as well as other protocols beyond one-on-one sessions, including group therapy and cognitive behavioral therapy focused on couples. The fact that MDMA is currently classified as a Schedule I drug and defined as having “no medical benefit” means that the only way to receive MDMA-assisted therapy right now is through clinical trials. However, the FDA has given its blessing to an expanded access program so that 50 patients can access MDMA-assisted therapy before it is approved and MAPS has committed to confronting accessibility and equity issues from its own side of the table. While not a sure thing, with MAPS’ latest data and continued efforts in alignment with FDA requirements the hoped-for 2023 FDA approval of MDMA-assisted therapy for PTSD is closer to becoming a reality than ever before.


StaffOctober 15, 2020
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12min1010

A peer-reviewed study published in the research journal PLOS ONE demonstrates that MDMA-assisted psychotherapy is remarkably cost-effective when compared to currently available treatments for posttraumatic stress disorder (PTSD). It is estimated that a public healthcare payer or private insurer making MDMA-assisted psychotherapy available to 1,000 patients with PTSD would reduce general and mental health care costs by $103.2 million over 30 years. This treatment has not yet been approved by the FDA, does not work for everyone, and carries risks even in therapeutic settings.

Lead author Elliot Marseille, Dr.P.H., M.P.P., said, “MDMA-assisted psychotherapy is conducted by a licensed psychologist and trained clinician over the course of twelve sessions with three sessions lasting six or more hours. The cost of that time is not inconsiderable, but in just over three years, healthcare providers will break even on the costs of mental health and general medical care. These estimates are promising yet likely too conservative: the study did not measure the value of increased productivity or lower disability payments as patients recover from PTSD and is constrained by the limited availability of data on the long-term trajectory of PTSD. Further research will be needed to determine the full financial, personal, and societal benefits of MDMA-assisted psychotherapy for PTSD.”

Berra Yazar-Klosinski, Ph.D., Deputy Director and Head of Research Development and Regulatory Affairs for MAPS Public Benefit Corporation and co-author, developed the treatment manuals governing MDMA-assisted psychotherapy. She notes, “A growing body of evidence suggests that MDMA-assisted psychotherapy is often more effective than currently available treatments for PTSD, a notoriously difficult-to-treat condition. Previous research has focused on safety and efficacy and indicates statistically significant improvements over currently available treatments with a reduction in symptoms for 82% of participants. This study should compel healthcare providers to include MDMA-assisted psychotherapy as a covered treatment for PTSD following FDA approval.”

Rick Doblin, Ph.D., Executive Director of MAPS and a study co-author, states,  “The profound personal toll of PTSD can include a deterioration in physical health, relationships, and ability to participate in social activities along with the anxiety, insomnia, and suicidal ideation that mark the condition. By demonstrating a return of an average of 5.5 quality-adjusted life-years over 30 years, we have shown that MDMA-assisted psychotherapy has the potential to reduce more than the personal burden of PTSD, contributing to improved health outcomes and reduced healthcare burdens for payers and providers.”

The cost-effectiveness of MDMA-assisted psychotherapy from the U.S. healthcare payers’ perspective was constructed with a decision-analytic Markov model to portray the costs and health benefits of treating patients with chronic, severe, or extreme, treatment-resistant PTSD. Efficacy was based on the pooled results of six randomized controlled trials with the 105 subjects who participated in Phase 2 trials and a four-year follow-up of 19 of those subjects. Other inputs were based on published literature and on assumptions when data were unavailable. Results are modeled over a 30-year analytic horizon and conducted extensive sensitivity analyses. The model calculates expected medical costs, mortality, quality-adjusted life-years, and incremental cost-effectiveness ratio.

 


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