Psychedelic drug developers face setback as ecstasy-based drug rejected by FDA

2024-08-10 06:04

The U.S. FDA has rejected privately-held Lykos Therapeutics' drug related to the psychedelic MDMA, also known as ecstasy, for PTSD.
The issuing of a Complete Response Letter for midomafetamine is not that surprising considering an agency advisory committee in June did not endorse the idea that the benefits of the drug outweigh the risk or that the drug was effective.
Lykos said the FDA requested another phase 3 trial. The company noted it plans to ask the FDA for a meeting to reconsider their decision and address any recommendations for an application resubmission.
Although FDA briefing documents provided for the meeting said that studies indicated the MDMA treatment led to rapid and durable improvement in symptoms, scientists also expressed concerns about cardiac safety. In addition, they worried how given the effects MDMA has on mood and cognition, they questioned how studies could be truly blinded.
Publicly traded psychedelic-focused drug developers include Mind Medicine (NASDAQ:MNMD), Atai Life Sciences (NASDAQ:ATAI), COMPASS Pathways (NASDAQ:CMPS), Cybin (NYSE:CYBN), and GH Research (GHRS).
Nano-caps include 180 Life Sciences (ATNF), Enveric Biosciences (ENVB), Seelos Therapeutics (NASDAQ:NASDAQ:SEEL), SciSparc (SPRC), Bright Minds Biosciences (DRUG), and Clearmind Medicine (CMND).

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