If you are someone who suffers from post-traumatic stress disorder, then you might have been asking for a while now the question: When will MDMA-assisted therapy finally be available as an option for me? There was recently big news on this and we want to share it with you.
MDMA therapy has been in the works since 1986 when MAPS (the Multidisciplinary Association for Psychedelic Studies) was fund raising for preclinical animal studies to establish the basic effects and safety of MDMA. Ten years later, in 1996 Dr. Charles Grob published the first Phase I clinical study of MDMA in humans. The first study of MDMA-assisted therapy for the treatment of post-traumatic stress disorder was conducted in 2000. In 2017, the FDA granted MDMA-assisted therapy “breakthrough therapy” designation. As you can see, the road to making MDMA-assisted therapy available to the public has been paved across multiple decades of consistent hard work.
On February 9, 2024, MAPS (now Lykos Therapeutics) announced that the New Drug Application was accepted by the FDA with priority review. A target action date is set for August 11, 2024.
A couple of things could happen once we hear from the FDA in August. One possibility is that the FDA approves MDMA-assisted therapy for use in adults with PTSD in August. In this case, several more months (perhaps even up to a year) will be necessary for the ripple of other things that need to happen before MDMA is available in your therapist’s office, including possible re-scheduling by the DEA, approving the official drug label, distributing information to clinical providers, and ramping up the move toward getting MDMA into the healthcare and pharmacy systems.
Another possibility is that the FDA could ask MAPS to develop stronger risk evaluation and mitigation strategies to manage any particular serious adverse effects that the FDA is concerned about based on clinical trial data. For example, the FDA could request a variety of elements to assure safe use, such as pharmacy certification, patient registry participation, or other documentation of safe use, each of which could add minor or substantial time to the eventual rollout of MDMA-assisted therapy.
In sum, while things are moving quickly now, especially given the nearly four decades of research that had to happen to get here today, at best we could see MDMA-assisted therapy available in early 2025. Perhaps initial availability will begin with a limited number of sites that already have trained doctors and clinicians based on their work on prior MDMA research studies. More conservatively, we might be looking at later in 2025 or 2026 before we really see it start to rollout beyond a handful of limited sites. The good news is that only a small percentage of drugs ever make it all the way through from preclinical animal studies all the way through Phase I, II, and III clinical studies in humans for consideration for FDA approval. Having made it this far along in the approval process, we remain optimistic that the finish line is in close sight.
At An Enduring Love, we have multiple providers who are MAPS-trained for MDMA-assisted therapy. To stay up to date with the latest news on MDMA-assisted therapy availability, be sure to subscribe to our mailing list.