Drugmaker Lykos Therapeutics had asked the FDA to approve its MDMA capsules as part of a therapy regimen for treating PTSD. It says another study will take "several years." ...

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 ...

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 ...

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.

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.

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.

Federal health regulators on Friday declined to approve the psychedelic drug MDMA as a therapy for PTSD, a major setback for groups seeking a breakthrough decision in favor of using mind-altering s… ...

Drugmaker Lykos Therapeutics had asked the FDA to approve its MDMA capsules as part of a therapy regimen for treating PTSD. It says another study will take "several years." ...

The U.S. Food and Drug Administration (FDA) has decided not to approve a psychedelic treatment -- along with therapy -- to ...

FDA rejects MDMA therapy for treatment of PTSD. ... The FDA was considering an application for a treatment manufactured by the California-based biotech Lykos Therapeutics that involves intense ...

Supporters of psychedelic therapy hoped that MDMA would make history as the first illegal psychedelic to win FDA approval, paving the way for similar drugs to enter the medical mainstream.

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.