Unlock Editor’s Digest for free
FT editor Roula Khalaf has chosen her favorite stories in this weekly newsletter.
First mental health treatment using Schedule 1 drug MDMA faces major regulatory hurdles as U.S. Food and Drug Administration poised to ask outside experts to scrutinize treatments for post-traumatic stress disorder are doing.
Lycos Therapeutics’ MDMA-assisted therapy for PTSD is scheduled to be reviewed next month by an FDA advisory panel that will decide whether to approve the controversial treatment, two people familiar with the matter said. You will be voting on which one.
This move has a major impact on the early stages of psychedelic-based treatments for mental health problems, as many other biotech companies are conducting late-stage trials of psychedelic-based mental health treatments.
The decision to convene the committee, which could be announced as early as this week, comes as the FDA is taking a very cautious approach to combining new drugs and mental health treatments, which have historically carried harsh criminal penalties. It is shown that. hindrance.
An interim review by the Institute for Clinical and Economic Review of two clinical studies related to Lykos’ PTSD treatment raised concerns about the design and conduct of the trials. The influential nonprofit said it had created “much uncertainty about the balance of benefits and harms” of the treatment.
By the conclusion of Lycos’ second late-stage study of PTSD treatment, in which patients took MDMA while receiving psychotherapy, 71% of the MDMA group had improved sufficiently to no longer meet diagnostic criteria for PTSD, whereas 71% of the MDMA group had improved sufficiently to no longer meet diagnostic criteria for PTSD. , 48% did not meet diagnostic criteria for PTSD. in the placebo group.
However, ICER expressed concern about the challenges inherent in “double-blind” patients in psychedelic drug research, saying that the drug’s apparent hallucinogenic effects make it difficult for both patients and researchers to be sure who is being treated. He said it was almost impossible to figure out.
After being contacted for comment by the Financial Times, Lycos chief executive Amy Emerson said in a statement:[looked] We look forward to the opportunity to discuss its therapeutic applications before the FDA committee.
Those close to Lycos said they expected the advisory committee to be convened and were still hopeful that the decision to convene the committee would not delay the drug’s planned approval date of Aug. 11. He said he is doing so. The results of the panel’s vote are not binding, but are typically followed by government agencies.
The advisory committee will likely provide an opinion on which particular patients should receive treatment. Officials said the FDA was approaching the decision with caution because it rarely reviews treatments that involve psychotherapy, not just drugs.
“Certainly there is a labeling issue that the FDA is concerned about, and that is who has the PTSD for which the treatment is approved,” said ICER Chief Medical Officer David. Lind said. “They really need to understand what the treatments are. . . . There were a lot of treatment options in these trials, so we needed to move this forward, but it’s important to get this out. I actually think it poses a problem with the method.”
The psychedelic drug field has attracted billions of dollars of investment in recent years. Lykos was spun out of the Interdisciplinary Association for Psychedelic Research, a nonprofit organization that has been an outspoken defender of psychedelic drugs since its founding in 1986 by Rick Doblin.
Earlier this year, Ricos raised $100 million in a funding round from 10 investors, including a philanthropic foundation run by hedge fund billionaire Stephen Cohen and his wife Alexandra.
If the drug is approved by the FDA, the Drug Enforcement Administration would have 90 days to reclassify MDMA as a less harmful drug, since the Schedule 1 category restricts the drug’s use for medical purposes. is given.
London-based Compass Pathways plans to release data later this year from a Phase 3 trial in 800 subjects who took synthetic psilocybin for treatment-resistant depression, while Nasdaq Cybin, a publicly traded company, also produces psilocybin analogs as a treatment for major depressive disorder.
The FDA said it “cannot comment on potential or pending product applications or approvals.”
