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MDMA-Based Mental Health Treatment Faces Cautious US Regulator
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The first mental health treatment using Schedule 1 drug MDMA faces a significant regulatory hurdle as the US Food and Drug Administration is prepared to ask outside experts to examine it for post-traumatic stress disorder.
Lykos Therapeutics’ MDMA-assisted therapy for PTSD will be reviewed by an FDA advisory committee next month, which will vote on whether the controversial treatment should be approved, according to two people familiar with the matter.
The change has major implications for the nascent category of psychedelic-based treatments for mental health problems – as a number of other biotech companies conduct late-stage trials of psychedelic-based mental health treatments.
The decision to convene the panel shows the high degree of caution with which the FDA is approaching a new class of medications that have historically carried severe criminal penalties in combination with therapy to treat mental health disorders.
An interim review of the two clinical trials associated with Lykos’ PTSD treatment by the Institute for Clinical and Economic Review raised concerns about the design and conduct of the trials. The influential non-profit group said it raised “many uncertainties about the balance between benefits and harms” of the treatment.
At the conclusion of the second final phase of Lykos to study In PTSD treatment, during which patients take MDMA while receiving psychotherapy, 71% of people in the MDMA group improved enough to no longer meet criteria for a PTSD diagnosis, compared with 48% in the placebo group.
But ICER expressed concern about the challenges inherent in “double-blinding” patients in a study of a psychedelic drug, saying it was almost impossible to ensure that neither patients nor researchers knew who was undergoing the treatment due to the obvious hallucinatory effects of the drug. medicine.
After being approached by the Financial Times for comment, Lykos chief executive Amy Emerson said in a statement that the company “[looked] looking forward to the opportunity to discuss” his treatment application on the FDA panel.
People close to Lykos said they expected an advisory committee to be convened and were still hopeful that the decision to convene the panel would not delay the treatment’s scheduled Aug. 11 approval date. The results of the panel’s votes are not binding, but are normally monitored by the agency.
The advisory panel is likely to weigh in on which specific patients should have access to treatment. The FDA is also handling the decision cautiously, as it rarely reviews treatments that involve psychotherapy as well as medications, the people said.
“Certainly, there is a labeling issue that the FDA will be interested in: who has PTSD that matches what the therapy is approved for,” said David Rind, chief medical officer at ICER. “They really need to understand what therapy is. . . moving forward with this because there were so many therapy options in these trials, and I really think that causes problems in how you communicate this.”
The psychedelic drug sector has accumulated billions of dollars in investment in recent years. Lykos was spun off from the Multidisciplinary Association for Psychedelic Studies, a nonprofit group that has been an outspoken advocate of psychedelic drugs since it was founded by Rick Doblin in 1986.
Earlier this year, Lykos raised $100 million in a funding round from 10 investors, including the charitable foundation run by hedge fund billionaire Steven Cohen and his wife Alexandra.
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If the drug is approved by the FDA, the Drug Enforcement Administration will have 90 days to reclassify MDMA as a less harmful drug, since the schedule 1 category restricts the drug’s use for medical purposes.
London-based Compass Pathways is expected to publish data later this year from a phase three trial of 800 humans who took synthetic psilocybin for treatment-resistant depression, while Nasdaq-listed Cybin will also begin its trial stage looking at a psilocybin analogue as a treatment for major depressive disorder.
The FDA said the agency “cannot comment on potential or pending product applications or approvals.”