Breaking news: F.D.A. panel votes against MDMA-assisted therapy for PTSD

As the excellent psychedelic newsletter 'The Microdose' reported "On Tuesday, the Food and Drug Administration’s Psychopharmacologic Drugs Advisory Committee voted overwhelmingly to reject MDMA-assisted therapy in the treatment of post traumatic stress disorder, or PTSD. The FDA will issue its final decision on the matter in mid-August but in the majority of cases, the federal agency’s decisions align with the vote of the independent panelists on advisory committees … Tuesday’s meeting made it clear that the FDA has real trepidations with Lykos’s application. The committee’s vote is not binding, meaning the FDA could still choose to approve MDMA-assisted therapy for PTSD. But according to a 2023 JAMA article, if an FDA committee recommended approving a drug, the agency followed suit 97% of the time. If committees recommended against approval, the FDA’s final decision matched that recommendation 67% of the time.  The Microdose reached out to Lykos for comment. “While we are disappointed in the vote, we are committed to continuing to collaborate with the FDA with their ongoing review of our NDA over the coming weeks,” Lykos CEO Amy Emerson said in an emailed statement. “We will also work with the FDA to determine the most appropriate post-marketing plans to address the outstanding questions raised today, including how best to support the responsible integration of MDMA-assisted therapy into the healthcare system.”

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