Unlock Editor’s Digest for free
Roula Khalaf, editor of the FT, picks her favorite stories in this weekly newsletter.
The first mental health treatment using the Schedule 1 drug MDMA faces a significant regulatory hurdle as the U.S. Food and Drug Administration prepares to hire outside experts to review the treatment for post-traumatic stress disorder.
Lykos Therapeutics’ MDMA-assisted therapy is expected to be reviewed in the coming months by an FDA advisory committee that will vote on whether the controversial treatment should be approved, according to two people familiar with the matter.
The decision to convene the panel, which could be announced as soon as this week, shows the great caution with which the FDA is approaching a new class of drugs that have historically been subject to harsh criminal penalties when combined with therapy to treat mental illness Disturbances.
An interim review of the two clinical trials related to Lykos’ PTSD treatment by the Institute for Clinical and Economic Review found concerns about the design and conduct of the trials. The influential nonprofit group said it had expressed “many uncertainties about the balance of benefits and harms” of the treatment.
After completing Lykos’ second late-stage trial for PTSD treatment, in which patients take MDMA while receiving psychotherapy, 71 percent of people in the MDMA group improved to the point where they met the criteria for PTSD -No longer fulfilled the diagnosis, compared to 48 percent in the placebo group.
However, ICER expressed concern about the challenges involved in “double blinding” patients in a study of a psychedelic drug, saying it was nearly impossible to ensure that neither patients nor researchers were aware of it due to the drug’s apparent hallucinatory effects who undergoes the treatment.
People close to Lykos said they had expected an advisory committee to be convened and were still confident that the decision to convene the committee would not delay the treatment’s expected Aug. 11 approval date. The results of the panel’s votes are not binding, but are generally followed by the agency.
The advisory panel is likely to issue an opinion on which specific patients should have access to the treatment. The FDA is also approaching the decision with caution because it rarely reviews psychotherapy and medication treatments, the people said.
“Certainly there is a labeling issue that the FDA will be interested in: Who has PTSD that is consistent with what the therapy is approved for,” said David Rind, ICER’s chief medical officer. “You really need to understand what therapy is.” . . I need to move forward with this because there were a lot of therapeutic options in these studies and I actually think this is causing problems in disseminating this information.”
The Lykos approval decision has major implications for the emerging category of psychedelic treatments for mental health problems – as a number of other biotech companies are conducting late-stage trials of psychedelic treatments for mental health problems.
The psychedelic drug sector has attracted billions of dollars in investment in recent years. Lykos grew out of the Multidisciplinary Association for Psychedelic Studies, a nonprofit group that has been a vocal advocate for psychedelic drugs since its founding by Rick Doblin in 1986.
Earlier this year, Lykos raised $100 million in a funding round from 10 investors, including the charitable foundation of hedge fund billionaire Steven Cohen and his wife Alexandra.
If the drug is approved by the FDA, the Drug Enforcement Administration will have 90 days to reclassify MDMA as a less harmful drug, as Category 1 restricts the use of drugs for medical purposes.
London-based Compass Pathways is expected to release data later this year from a Phase III trial of 800 subjects taking synthetic psilocybin for treatment-resistant depression, while Nasdaq-listed Cybin is also investigating its late-stage study Psilocybin analogue is used to treat severe depressive disorders.
Lykos did not immediately respond to multiple requests for comment. The FDA said the agency “cannot comment on potential or pending product applications or approvals.”