FDA advisors just said no to the use of MDMA as a therapy

If the FDA denies approval of MDMA therapy, Lykos or another company could conduct additional studies and reapply. Many of the committee members said they believed MDMA does hold promise, but that the studies conducted thus far were inadequate to demonstrate the drug’s safety and efficacy.

Psilocybin is likely to be the next psychedelic therapy considered by the FDA, and in some ways, it might have an easier path to approval. The idea behind MDMA is that it alleviates PTSD by helping facilitate psychotherapy. The therapy is a crucial component of the treatment, which is problematic because the FDA regulates drugs, not psychotherapy. With psilocybin, a therapist is present, but the drug appears to do the heavy lifting. “We are not offering therapy; we are offering psychological support that’s designed for the patient’s safety and well-being,” says Kabir Nath, CEO of Compass Pathways, the company working to bring psilocybin to market. “What we actually find during a six- to eight-hour session is most of it is silent. There’s actually no interaction.”

That could make the approval process more straightforward. “The difficult thing … is that we don’t regulate psychotherapy, and also we don’t really have any say in the design or the implementation of the particular therapy that is going to be used,” said Tiffany Farchione, director of the FDA’s division of psychiatry, at the committee meeting. “This is something unprecedented, so we certainly want to get as many opinions and as much input as we can.”

Another thing

Earlier this week, I explored what might happen if MDMA gets FDA approval and how the decision could affect other psychedelic therapies.

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