The FDA Might Reject MDMA Therapy—but Not for the Reasons You Think

for Slate

What was supposed to be a groundbreaking step in mental health treatment became a devastating rebuke of a biopharmaceutical company at the forefront of researching MDMA-assisted therapy as a treatment for post-traumatic stress disorder. Although many psychedelic-therapy advocates were disappointed by the decision, the move could actually prevent serious harm to those seeking treatment—and ultimately help secure a safe future for psychedelic-assisted therapy.

On June 4, a panel advising the Food and Drug Administration voted 9–2 that Lykos Therapeutics, a company developing psychedelic drug treatments for mental health issues, had not proved that its MDMA-assisted therapy protocol was an effective treatment for PTSD, and voted 10–1 that the risks of MDMA—also known as ecstasy—outweigh its benefits. The FDA will officially vote Aug. 11 on whether to approve the treatment. The agency isn’t required to follow the panel’s recommendation, but given the magnitude of the safety concerns raised by the committee, and the landslide votes, FDA approval would be a fairly stunning turn of events.

What was supposed to be a groundbreaking step in mental health treatment became a devastating rebuke of a biopharmaceutical company at the forefront of researching MDMA-assisted therapy as a treatment for post-traumatic stress disorder. Although many psychedelic-therapy advocates were disappointed by the decision, the move could actually prevent serious harm to those seeking treatment—and ultimately help secure a safe future for psychedelic-assisted therapy.

On June 4, a panel advising the Food and Drug Administration voted 9–2 that Lykos Therapeutics, a company developing psychedelic drug treatments for mental health issues, had not proved that its MDMA-assisted therapy protocol was an effective treatment for PTSD, and voted 10–1 that the risks of MDMA—also known as ecstasy—outweigh its benefits. The FDA will officially vote Aug. 11 on whether to approve the treatment. The agency isn’t required to follow the panel’s recommendation, but given the magnitude of the safety concerns raised by the committee, and the landslide votes, FDA approval would be a fairly stunning turn of events.

For nearly four decades, the nonprofit Multidisciplinary Association for Psychedelic Studies has been the leading advocate for the legalization and medicalization of psychedelic drugs like MDMA, psilocybin, and LSD. In 2014 MAPS created Lykos Therapeutics (formerly MAPS PBC) as a for-profit drug development company. MAPS and Lykos have invested heavily in clinical trials evaluating the therapeutic potential of MDMA. Taking into account the anemic treatment landscape and the panel’s support of veterans’ groups, many observers expected the body to offer a resounding approval.

However, June 4 was unequivocally a “very bad day for Lykos,” Mason Marks, a visiting professor of law at Harvard Law School and lead of the Project on Psychedelics Law and Regulation at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, tells me. “Lykos largely created this situation for themselves.”

Continued at Slate.com

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