Share to Facebook Share to Twitter Share to Linkedin A U.S. Food and Drug Administration advisory committee voted on Tuesday against approving the use of the psychedelic MDMA in conjunction with therapy as a treatment for post-traumatic stress disorder, saying the available evidence does not show that the drug is effective and that the benefits outweigh the risks.
The decision marks a potential setback for supporters of the promising therapy and Lykos Therapeutics, a company formed by the Multidisciplinary Association for Psychedelic Studies (MAPS) to develop the treatment. After listening to public comments and a discussion period, the FDA’s independent Psychopharmacologic Drugs Advisory Committee voted 9-2 against approving MDMA combined with talk therapy as a treatment for PTSD. Additionally, the panel voted 10-1 that the benefits of MDMA do not outweigh the risks of taking the drug.
An FDA advisory panel has recommended that the agency not approve the use of MDMA-assisted therapy ...
[+] as a treatment for PTSD. Lykos backed the clinical trials with the hope that the FDA would approve the therapy as an effective treatment for patients with PTSD. The agency does not have to follow the recommendations of the advisory committee, but the FDA generally gives significant weight to the panel’s findings when making drug approval decisions.
About 200 people participated in the clinical trials, which combined the use of MDMA, a psychedelic commonly known as ecstasy, with talk t.
