Expert: MDMA for the Treatment of PTSD May Be FDA-Approved by the End of 2023

Pharmacy Times interviewed Ismail Lourido Ali, the director and counsel of policy and advocacy at the Multidisciplinary Association for Psychedelic Studies (MAPS), on psychedelic medicine policy and current advancements in the field.

During the discussion, Ali addresses what MAPS is and how MAPS is engaged with the field of psychedelic medicine and its use in health care.

Alana Hippensteele: So, to start, could you tell me a bit about what MAPS is, and how MAPS is engaged with the field of psychedelic medicine and its use in health care?

Ismail Lourido Ali: Absolutely. Thank you so much for having me. I really appreciate the invitation—I'm really excited to talk about this, as I usually am; it's a really interesting topic.

So, MAPS was founded actually in 1986—we just celebrated our 35th anniversary, and it was founded shortly after MDMA, or 3,4-methylenedioxy-methamphetamine, was emergency scheduled by DEA in about 1985. Prior to 1985, the molecule had been used in an unregulated way in psychotherapy as an adjunct to therapeutic care, couples therapy, PTSD, and other things.

After it was rediscovered in the late 70s by [Alexander] "Sasha" Shulgin, who's a well-known chemist who passed away some years ago, MAPS was founded in 1986 with the explicit purpose and mission of creating legal cultural and medical access to the responsible use of psychedelics in society. For the last 35 years, it's been working toward that goal, primarily with its flagship project of taking MDMA through the FDA approval process, so it could be prescribable as a pharmaceutical medication.

As of today, we are in the process of recruiting for our second phase 3 study. We made it through phase 1 and 2 and made it through our first phase 3 study, and we have the hope currently of a potential line of sight on approval if all goes according to the current path by about the end of 2023.

So, we're focusing primarily on PTSD as the indication for MDMA, but there are a number of investigator-initiated trials and other research about MDMA that has looked at a number of other indications, including social anxiety for adults with autism, eating disorders, couples therapy, and a few other things.

Alana Hippensteele: That is fascinating. I had no idea about the treatment for autism or eating disorders—that's really fascinating. I understand the PTSD element is one that I believe has been FDA approved; is that correct?

Ismail Lourido Ali: We're in the process of seeking FDA approval; it would be the first indication if we are to get approval. That's the thing—we're like just a year, maybe a couple years away from. I’ll also add that that's been the primary work of the MAPS public benefit corporation which is a wholly owned subsidiary of MAPS, the 501(c)(3), and the non-profit, which is also where I work, not just fully owns this for-profit drug development arm, but it also does public education, harm reduction, and policy reform, which is primarily my area of work.