Our expert panelists provide commentary on the June 4th FDA Committee meeting surrounding MDMA for PTSD, their interpretation of the meeting’s contents, and what it all means for MDMA therapy moving forward.
“Analyzing the Lykos Therapeutics FDA Committee Meeting” was a live webinar event that streamed live across the Nucleus ecosystem on Wednesday, June 5th at 3:00pm ET.
Moderator Dustin Robinson was joined by the CEO of Inbodied Life, Lauren Taus, and Edgar J. Asebey, Esq. of Keller Asebey Life Science Law PLLC. The trio summarized the outcomes from the committee meeting taking place the day prior (June 4th).
A transcript of the conversation can be found below.
Participants
Dustin Robinson
Dustin is a leader within the psychedelic ecosystem and has been ranked by Psychedelic Invest as the Top 100 Most Influential People in Psychedelics. As a licensed attorney and CPA with a law firm that exclusively works in the cannabis and psychedelic space and as the founder of a leading non-profit that is paving the way for psychedelic legalization, Dustin is an expert in understanding and capitalizing on opportunities within highly regulated industries. Dustin has been featured in top publications (i.e. Forbes) for his deep knowledge, experience, and advocacy in the psychedelic space; and his law firm has been listed by Psychedelic Invest as one of the Five Psychedelic Law Firms You Should Have on Your Radar.
Lauren Taus
Lauren is a licensed clinical therapist in both New York and California with a specialty in addiction and trauma treatment. As a clinician, Lauren integrates alternative modalities of treatment into her work. She trained with David Emerson under the supervision of Bessel van der Kolk at The Trauma Institute in Boston in trauma sensitive yoga, and she’s trained by the Multidisciplinary Association of Psychedelic Studies (MAPS) for MDMA assisted psychotherapy for complex PTSD.
Lauren is actively working under the supervision of Dr. Phil Wolfson, author of The Ketamine Papers, to offer ketamine assisted psychotherapy to accelorate healing for individuals who suffer from depression, anxiety and trauma. Alongside her father Stephen D. Taus MD, Lauren supports psychedelic assisted therapy research with the intention to bring these types of interventions back into the Western maintream model. Lauren graduated summa cum laude from Barnard College at Columbia University in 2004 with a BA in Religion before continuing on to NYU for her Masters in Social Work.
Lauren teaches yoga and meditation classes in the Los Angeles area. She has facilitated teacher trainings and she offers immersive wellness experiences globally. In her work as a wellness provider, Lauren has been featured in Yoga Journal, Women’s Health, Men’s Health, Health Magazine, USA Today, Self Magazine and more.
Lauren believes that individual and collective healing are intimately intertwined. As an activist and advocate for a safer world, she is dedicated to building bridges in the Middle East. She co-curated a delegation of Israeli and Palestinian peace activists to travel to Dharamsala and meet with the Dalai Lama to learn how to integrate non-violent approaches to conflict in the Holy Land. Lauren is a founding member of the Kosmic Kamels, a camp at Burning Man, comprised of individuals from countries in the Middle East whose passports preclude them from visiting one another’s homes. Camp members explore ways in which the 10 principles of Burning Man can be applied to conflict zones.
Edgar J. Asebey, Esq.
Edgar J. Asebey is a founding partner of Keller Asebey Life Science Law PLLC and has been practicing regulatory and transactional law for over 20 years. Mr. Asebey advises clients in the pharmaceutical, biotechnology, biologics, medical device, food and dietary supplement industries and represents clients
before the FDA, USDA, CBP, FTC, CPSC and EPA.
Mr. Asebey counsels clients and preforms regulatory due diligence in support of financings, public offerings and M&A transactions. He also advises emerging life science companies on patent portfolio development, pharmacoeconomics and clinical trial development. Since 2016, he has been advising cannabis companies and today provides regulatory compliance, due diligence and transactional services to hemp/CBD, cannabis/marijuana and psychedelic biotechnology companies. In addition to his law practice, Mr. Asebey is a venture partner in Iter Investments, a venture capital firm focused on supporting emerging psychedelic biotechnology companies, where he is in charge of regulatory due diligence matters. Most recently, Mr. Asebey co-authored the authoritative treatise, Legal Guide to the Business of Marijuana (PLI Press, 2023) and published the article FDA Law and the Psychedelic Renaissance (Food & Drug Law Institute Magazine, Spring 2024) and is considered an expert in the regulation of Cannabis, hemp-derived cannabinoids and psychedelics medicines.
Early in his career Mr. Asebey served as Patent and Licensing Advisor to the Natural Products Branch of the National Cancer Institute at the National Institutes of Health (NIH). He founded and served as president and CEO of Andes Pharmaceuticals, Inc., a natural products biotechnology company, from 1994 to 2000 and has served as in-house counsel to two life sciences companies. Most recently he was an equity partner in the Health Care & Life Sciences Practice Group at Jones Day and today serves as managing partner at Keller Asebey Life Science Law, PLLC.
Mr. Asebey studied molecular biology at the University of Chicago and spent 5 years working in molecular biology research laboratories at The University of Chicago and the University of Illinois School of Medicine. He holds a law degree from Catholic University of America (Washington, D.C.) and is licensed to practice law in Florida and Washington, D.C. He is a member of the American Bar Association, Food & Drug Law Institute (FDLI), Dade County Bar Association, and BioFlorida.
Transcription
Dustin: All right, and we are live. Thank you, everyone, for joining us. This is our discussion on the June 4th advisory committee meeting regarding Lycos’s MDMA trial. My name is Dustin Robinson, and I will be moderating this discussion.
By way of background, I’m the founder of Iter Investments, a venture capital fund that invests in mental and behavioral health therapies, including psychedelic medicines. I’m also the founder of Lumalex, a law firm that represents a lot of law firms, and Nucleus, which owns the platform psychedelicinvest.com, the platform we’re using for this meeting.
My goal today is to provide an overview of the advisory committee meeting and offer some insights into its implications. While we are all passionate about the psychedelic industry, it’s important to remain as objective as possible in our discussions today. We also want to answer your questions, so if you have any, please drop them in the comment box, and we will try to get to them at the end. There’s a lot to discuss, and I’ll try to keep it to an hour.
To kick it off, I’m going to ask each of the panelists to introduce themselves. Edgar, would you like to go first?
Edgar: Sure. Thank you, Dustin. I’m Edgar Asebey, managing partner of Keller Asebey Life Science Law, an FDA regulatory cannabis psychedelics law firm. I’ve been practicing for 26 years, primarily before federal agencies like FDA, USDA, CBP, and EPA. I started my career at the National Cancer Institute as a patent and licensing advisor and worked with the natural products branch. I also ran a natural products drug discovery company, Andy’s Pharmaceuticals, and I’m a venture partner at Iter Investments, where I’m responsible for regulatory due diligence of the psychedelic companies we invest in.
Dustin: Thank you. Lauren, you want to go next?
Lauren: Hi, I’m Lauren Taus, founder of InBodied Life, a group psychotherapy practice based in Los Angeles and an educational platform. I train other clinicians and physicians on working specifically with ketamine. I’m trained by MAPS and the Ketamine Training Center. I’ve been doing this work for about 15 years as a licensed clinical social worker in both New York and California. I’m hopeful about what’s available for us in the future.
Dustin: Thank you. And now, we have our special guest who joined us last minute. Dave, would you like to introduce yourself?
Dave: Sure. Thanks for having me and thanks to everyone for joining. I’m Dr. Dave Rabin, a board-certified psychiatrist and neuroscientist. I’ve been studying psychedelic medicines and chronic stress for about 20 years. I’m trained in ketamine-assisted therapy and MDMA-assisted therapy, and I’m the executive director of the Board of Medicine, a nonprofit medical board, and the chief medical officer and co-founder of Apollo Neuroscience.
Dustin: Thank you so much. There’s a lot to discuss. The meeting was all day yesterday, so we’re not going to cover everything, but we do want to get into the discussion points. I want to start with the vote because some of you may not have watched or know the outcome. The panel voted 10 to 1 that the benefits of MDMA therapy do not outweigh the risks, and 9 to 2 that the available data was insufficient to show MDMA therapy was effective in treating PTSD. It wasn’t a close call. We did not win the hearts of the panel whatsoever.
Before we discuss what led to that vote, Edgar, could you start us off with the meaning of this vote? How binding is it on the FDA, and what happens next?
Edgar: Sure. It’s important to put this in context. Whenever there’s a new drug application at the FDA, the FDA forms an advisory committee, in this case, the Psychopharmacology Drugs Advisory Committee, to review the application. The committee included outside professionals, university professors, an FDA official, an industry official, a consumer advocate, and a holistic medical doctor. Their recommendation is not binding on the FDA, but it carries a lot of weight. The FDA will gather information from these hearings and written reports to evaluate whether Lycos has met the burdens to show that MDMA is safe and efficacious. Given the compelling reasons against it, I believe the FDA would find it very hard to approve the current application.
Dustin: Thank you. Now, let’s talk about the reasons behind their votes. One main issue was functional unblinding. This is going to be an issue for all psychedelic trials. Although participants were randomized to either drug or placebo, the majority were able to accurately guess their treatment. Lauren and Dave, what are your thoughts on functional unblinding and its challenges in the psychedelic industry?
Lauren: These medicines have an obvious impact on our bodies. Functional unblinding means participants know whether they took the pill or not. When someone takes a medicine with psychoactive properties, they feel different, which can lead to more radical healing. But for study purposes, blinding gives us more robust data. It’s difficult to standardize, especially with these kinds of medicines.
Dave: Placebo refers to the belief effect that a medicine will or won’t work. In mental health trials, there’s always a component of functional unblinding where subjects can guess whether they received the active drug. MAPS did a good job placebo-controlling by administering sub-threshold doses of MDMA. This shows that the response rates to MDMA therapy are much higher than standard care, which can’t be fully explained by the placebo effect alone. The functional unblinding argument doesn’t hold much weight here.
Edgar: I agree. It’s common with psychedelics, but the committee was also concerned about unblinding of therapists and allegations of pressure to report or not report adverse effects. These aggravating factors made the committee more sensitive to the issue. However, it’s impossible to eliminate functional unblinding entirely.
Dustin: Let’s move on to the therapy aspect. The panel discussed the lack of an arm with MDMA without therapy. They questioned whether therapy is needed and raised concerns about standardizing therapy protocols. Lauren and Dave, how important is the therapy aspect in psychedelic medicine?
Lauren: Chronic loneliness is detrimental to our health. Good therapy involves a relationship and personalized care. The medicine amplifies the therapeutic experience. Standardizing therapy is challenging because it’s a human process. The relationship is essential, and therapy can’t be fully measured.
Dave: Psychotherapy is personalized, and MAPS did an incredible job training new providers for the phase three trial. The results were even better than the phase two trial. MDMA alone doesn’t achieve these benefits; it’s the combination with therapy that amplifies the experience. The therapy component is critical and should be considered a strength rather than a weakness.
Edgar: From a regulatory perspective, FDA can’t evaluate therapies. They can regulate safety but not efficacy. This is a structural problem that needs to be resolved. The therapy component must be regulated by the appropriate bodies, and there needs to be coordination with the FDA. It’s a novel challenge that requires a new regulatory framework.
Dustin: On the safety side, the panel seemed softer but raised concerns about cardiovascular risk and the lack of information on abuse potential. Dave, can you talk about the safety issues, especially the cardiac profile?
Dave: The side effects of MDMA therapy are well-known and similar to other amphetamines like Adderall, which is widely prescribed. The short-term increase in blood pressure and heart rate is less concerning than the black box warnings for increased suicidality with current PTSD medications like Paxil and Zoloft. The safety profile of MDMA is acceptable when compared to these alternatives.
Edgar: Post-marketing studies or REMS (Risk Evaluation and Mitigation Strategies) could address these safety concerns. The FDA may require additional data collection after approval. However, REMS are typically for observing adverse effects, not for integrating therapy, which complicates the issue further.
Dustin: With the upcoming FDA decision on August 11th, what are your thoughts on the potential outcomes? Can the FDA suggest further studies or improvements without outright rejecting the application?
Edgar: The FDA may suggest new studies or improvements, especially addressing the therapy component. They might not outright reject the application but will likely require additional evidence to fill data gaps.
Dave: The FDA has worked closely with MAPS for years, understanding the impact of PTSD and the potential benefits of MDMA therapy. Considering the dire need for effective PTSD treatments, the FDA might expedite approval with conditions for further data collection.
Lauren: This process highlights the gap between practice and regulatory approval. The FDA needs to recognize the unique nature of this therapy and the robust data supporting it. The urgency of addressing PTSD in our communities should influence their decision.
Dustin: For other psychedelic drug development companies, what lessons should they take from this meeting?
Edgar: Companies should engage with both the FDA and regulatory bodies for therapy. They need to ensure their clinical trial designs address the issues raised by the panel and follow established protocols to facilitate approval.
Dave: Follow the big pharma formula for drug approval while adapting to the unique aspects of psychedelic therapy. Learn from MAPS’s approach and navigate the regulatory landscape effectively.
Lauren: Understand the need for data-driven processes while maintaining the integrity of the therapeutic relationship. Balance the requirements for approval with the personalized nature of psychedelic therapy.
Dustin: Thank you all for your insights. If anyone wants to reach out, please contact info@iterinvestments.com. Edgar, Lauren, and Dave, could you share your contact information?
Dustin: Thank you all for attending, and let’s continue working