With only a few weeks left in the year, concern was rising over why MAPS PBC hadn’t yet submitted its NDA. All that, however, was put to rest yesterday when the Public Benefit Corporation announced that its submission to the FDA was officially complete.
On December 12, 2023, the Multidisciplinary Association for Psychedelic Studies Public Benefit Corporation, or MAPS PBC, announced that it had submitted its New Drug Application for MDMA-assisted therapy to the Federal Drug Administration (FDA). When you put it like that, it sounds like a bunch of pharmaceutical business jargon. However, there is one key aspect of this particular NDA that makes it stand out from the approximately 2000 that the FDA receives every year.
This is the first psychedelic in history to be submitted to a federal agency for approval as a medical treatment. After more than fifty years of psychedelics existing in society entirely underground, people in the US struggling with PTSD may finally have access to legal, insurance-covered MDMA-assisted therapy. Furthermore, people wishing to use it in a clinical setting for other reasons will be able to do so through off-label prescription— though it will be costly.
Though the NDA has been submitted, the question remains— when will this therapy become available to the public?
Previous predictions placed an FDA approval of MDMA-assisted therapy at the beginning of 2024. It is clear now that this timeline is unlikely. From the time of submission, the FDA generally takes about 10 months to review and either approve or reject a New Drug Application. However, priority applications, are given a six-month timeline. Since this treatment does have “breakthrough” status, we could see an approval as soon as June.
Once again, the psychedelic industry is playing a waiting game. Most of 2023 was spent waiting to see if the MAPP II study results (one of the two clinical trial results being used to submit this treatment for FDA approval) would be strong enough to gain approval. The positive results were released in mid-September and thus began the waiting period for MAPS to submit its NDA.
Now that the NDA is in, the fate of legal psychedelic therapy is in the hands of the Federal Government— which is more daunting than its fate being in the hands of a company started by a man who spent the better part of his life dedicated to the psychedelic movement.
Many in the industry have said that the FDA approval of MDMA-assisted therapy is all but a done deal. In fact, they’ve been saying that since before the clinical trials results were available to provide any support to this hypothesis. Though the excitement and passion of psychedelic enthusiasts are admirable, it can sometimes act as encouragement to make overly risky decisions. Those working in the industry should exercise caution not to get ahead of themselves just yet.
The truth is, this isn’t a done deal until it is a done deal. However, the FDA did grant this therapy “breakthrough status,” meaning that the agency acknowledged its potential for treating PTSD before the phase III clinical trial data was available to confirm its efficacy. Since then, MAPS has produced two phase III clinical trials that met primary and secondary endpoints. In other words, things are looking promising. However, FDA approval is only half the battle for MDMA-assisted therapy
After the (potential) legalization, comes the hard work of bringing this treatment to market. Unlike the process so far, however, this task must be shouldered by the entire industry— not just MAPS.
In order for this treatment to become available to people across the US, the industry needs therapists, educators, clinics, insurance providers and many more services available to support this rollout. The preparation for this has already begun.
The infrastructure for psychedelic-assisted therapy is already well underway, which means that the fate of this FDA decision can make or break the industry. If it were to be denied, some companies would not be able to stay afloat due to the bets they have placed on this going through. The Psychedelic Index would take a big hit (bigger than it already has this year), as confidence over wether or not it is possible to get a psychedelic drug through government approval wanes. Some companies would be able to wether through, however, their business plans would certainly have to be reworked.
If this approval does go through— which the data suggests that it will— there is a long road ahead. While the submission of the NDA signifies a crucial step forward, the journey towards making MDMA-assisted therapy accessible to the public remains fraught with uncertainties.
Nevertheless, the uncertainty of what comes next certainly doesn’t take away from the incredible nature of this monumental moment. The submission of the NDA for MDMA-assisted therapy marks a historic milestone for psychedelics.
The journey to this point has taken decades, so despite the uncertainty about what happens next, there is (and certainly should be) joy and celebration in this major accomplishment. At the end of the day, the most important thing is helping people who are suffering access treatments that could change their lives and the lives of their loved ones for the better. All the chaos of trials, FDA approval, and infrastructure development seem insignificant next to the potential of what MDMA-assisted therapy could offer those in need.