US regulator expresses caution towards MDMA-based mental health treatment

The first mental health treatment using the schedule-1 drug MDMA is facing a significant regulatory hurdle as the US Food and Drug Administration (FDA) prepares to seek outside experts’ opinions on its use for post-traumatic stress disorder (PTSD). Lykos Therapeutics’ MDMA-assisted therapy for PTSD is set to be reviewed by an FDA advisory committee next month, with the committee voting on whether the controversial treatment should be approved.

This move has major implications for the emerging field of psychedelic-based treatments for mental health issues, as several other biotech companies are conducting late-stage trials on similar treatments. An interim review of the clinical studies associated with Lykos’ PTSD treatment raised concerns about the design and conduct of the trials, with the Institute for Clinical and Economic Review highlighting uncertainties about the treatment’s benefits and harms.

Despite these concerns, the results of Lykos’ second late-stage study showed promising outcomes, with 71% of patients in the MDMA group no longer meeting the criteria for a PTSD diagnosis, compared to 48% in the placebo group. However, challenges with “double-blinding” patients in a study involving a psychedelic drug were noted, as it was difficult to ensure that neither patients nor investigators knew who was receiving the treatment due to the drug’s hallucinatory effects.

The FDA’s decision to convene an advisory panel reflects the agency’s cautious approach to reviewing new treatments that combine psychotherapy with drugs. If approved, the Drug Enforcement Administration will have 90 days to reclassify MDMA as a less harmful drug, potentially opening the door for more research and treatments in the psychedelic drug sector.