Reviewing the FDA Advisory Committee Decision on MDMA

John J. Miller, MD, Editor-in-Chief of Psychiatric Times, puts in perspective the US Food and Drug Administration Psychopharmacologic Drugs Advisory Committee's decision on MDMA for the treatment of posttraumatic stress disorder (PTSD). While they voted against recommending FDA approval for MDMA, the picture is more complicated, shared Miller. The committee, though valid in its concerns, does not have final say over this decision. The FDA will issue its verdict on Lykos’ application on August 11, 2024. This give both Lykos and the FDA 2 months to further analyze data and highlighted concerns.

As of today, we have only 2 drug approved for the treatment of PTSD, sertraline and paroxetine, which have modest effect. There is a huge unmet need in this population, stressed Miller.

The committee voted 10 to 1 against MDMA, citing 3 issues: functional unblinding, the adverse event of increased blood pressure/heart rate, and abuse potential of MDMA. Miller addresses each of these concerns.

He uses esketamine (Spravato), approved in 2019, as a comparison in terms of Risk Evaluation and Mitigation Strategy protocol. This treatment carries 2 of the same risks as MDMA: increased blood pressure and abuse potential. Spravato must be used in conjunction with the REMS protocol, which seems to mitigate the associated risks.

While he is unsurprised by the committee's findings, he urges clinicians to stay tuned. "This is uncharted territory for us in psychiatry and for the FDA. It's an exciting time, and there is a lot of promise moving forward in medication-assisted psychotherapy."

Dr Miller is Medical Director, Brain Health, Exeter, New Hampshire; Editor in Chief, Psychiatric Times; Staff Psychiatrist, Seacoast Mental Health Center, Exeter; Consulting Psychiatrist, Insight Meditation Society, Barre, Massachusetts.