FDA panel rejects MDMA-assisted therapy for PTSD
An independent advisory panel of the Food and Drug Administration rejected the use of MDMA-assisted therapy for post-traumatic stress disorder on Tuesday [6/4/2024]. While the vote is not binding on the F.D.A., the agency often follows the recommendations of its advisory panels. Members of an independent scientific advisory committee voted 9 to 2 that human trials of MDMA did not prove its efficacy. They also voted 10 to 1 that the risks of MDMA, also known as ecstasy, outweight its benefits. A final decision by the agency is expected in mid-August [2024]. Dr. Walter Dunn, a psychiatrist at UCLA, was one of the few who voted in favor of the treatment’s efficacy. He acknowledged the misconduct allegations, but said ultimately the effect sizes of the treatment were large enough to indicate it can be effective for PTSD.
It’s a blow to the drug’s sponsor, Lykos Therapeutics, a private, California-based company registered as a public benefit corporation, but the setback has also hit investor confidence in an array of publicly traded companies working to bring psychedelics to clinics … many of the committee members said they were especially worried about the failure of Lykos to collect detailed data from participants on the potential for abuse of a drug that generates feelings of bliss and well-being… committee members also noted that Lykos was missing data on the drug’s effects on liver function and whether participants went on to abuse MDMA after the trial… Further raising concerns, a report from the Institute for Clinical and Economic Review, a non-profit group in Boston, Massachusetts, that analyses medical procedures, includes allegations that people who’d had bad experiences in the initial trials had been discouraged from participating in the follow-up study. Lykos denied this at the committee meeting, and the FDA will complete the investigation before its makes a decision on the drug. “I absolutely agree that we need new and better treatments for PTSD,” said Paul Holtzheimer, deputy director for research at the National Center for PTSD, a panelist who voted no on the question of whether the benefits of MDMA-therapy outweighed the risks … should it win F.D.A. approval, federal health authorities and Justice Department officials would have to follow certain steps to downgrade the drug’s listing, much like the process now underway with cannabis … The FDA is expected to decide by August 11 [2024] on the approval of MDMA plus psychotherapy for PTSD, and while the agency typically goes along with advisory committee recommendations, it doesn’t always. The US has yet to approve a psychedelic drug for medical use, so a green light from the agency would represent a major milestone for a class of drugs that has been banned since the 1970s… While MDMA is currently listed as a Schedule I drug, the agency’s [F.D.A.] review found it has the same abuse potential as a Schedule II stimulant, a category that includes cocaine. “We’re actually managing more and more severe cases of MDMA overdose, and so I’m less concerned about the safety in the acute setting, but more chronically if they go on to abuse MDMA,” said Maryann Amirshahi, a professor of emergency medicine at Georgetown University and a member of the committee.
Original Article (New York Times, Wired, Forbes, NPR, Nature):
F.D.A. panel rejects MDMA-aided therapy for PTSD & The case for MDMA’s approval is riddled with problems & Psychedelic stocks tank after FDA advisors shoot down MDMA therapy for PTSD & FDA advisors reject MDMA therapy for PTSD, amid concerns over research & FDA advisors reject MDMA therapy for PTSD, amid concerns over research & MDMA therapy for PTSD rejected by FDA panel
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