Behavioral Health Business June 6, 2024
Morgan Gonzales

The psychedelic industry learned important lessons when a Food and Drug Administration advisory committee voted to reject a landmark MDMA-based therapy designed to treat PTSD.

The rejection shook investors and demonstrates that FDA approval for novel psychedelic drugs is further away than previously thought, but industry insiders remain confident in the industry’s long-term success.

The Psychopharmacologic Drugs Advisory Committee voted two to nine on the question of whether Lykos Therapeutics’ MDMA therapy was effective as a post-traumatic stress disorder treatment and one to 10 on the question of whether the benefits of the therapy outweigh the risks.

“We are disappointed by the result of the FDA advisory committee’s vote,” Daniel Love, co-founder and partner of psychedelic-focused venture studio Beckley Waves,...

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Topics: Biotechnology, FDA, Govt Agencies, Mental Health, Patient / Consumer, Pharma, Pharma / Biotech, Provider
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