Study: MDMA therapy for PTSD shows positive results 04:26. The Food and Drug Administration declined Friday to approve an application to treat post-traumatic stress disorder using the drug ...

The U.S. Food and Drug Administration (FDA) has decided not to approve a psychedelic treatment -- along with therapy -- to treat post-traumatic stress disorder (PTSD), according to Lykos ...

FDA rejects MDMA-assisted therapy for PTSD. The decision came after the agency's advisory committee said in June that there wasn't enough evidence the therapy was safe or effective.

HEALTH FDA rejects MDMA as psychedelic-based treatment for mental health, PTSD The agency has requested that Lykos Therapeutics conduct another Phase 3 trial to confirm safety and efficacy ...

In June, the FDA's Psychopharmacologic Drugs Advisory Committeevoted 9-2 against MDMA as an effective treatment for PTSD patients, and 10-1 that the drug's benefits do not outweigh the risks.

If approved, MDMA-AT would be the first psychedelic-based therapeutic cleared by the FDA for any condition in the US and the first PTSD medication to receive approval in 24 years.

Despite the FDA's rejection of MDMA-assisted therapy, Lykos Therapeutics plans to push ahead for approval, despite internal turmoil and layoffs of 75% of company staff.

The Lykos study, which the panel criticized, found the MDMA treatment had about 71 percent efficacy for PTSD. “Delaying FDA approval of MDMA-AT dashes the hopes of millions of Americans who ...

Drugmaker Lykos Therapeutics had asked the FDA to approve its MDMA capsules as part of a therapy regimen they argued could be a breakthrough for treating challenging cases of PTSD.. Lykos said the ...

The U.S. Food and Drug Administration (FDA) has decided not to approve a psychedelic treatment -- along with therapy -- to treat post-traumatic stress disorder (PTSD), according to Lykos ...

Panel recommends FDA reject MDMA as treatment for PTSD. The advisory committee’s recommendation is nonbinding, and the agency’s final action sometimes differs. Updated June 4, 2024.

In June 2024, an FDA advisory committee voted overwhelmingly against the idea that the relevant clinical trials had proved the efficacy of MDMA for the treatment of PTSD.