The Food and Drug Administration (FDA) panel voted 10-1 against endorsing the safety of MDMA in treating PTSD, and 9-2 against its efficacy. The group cited flawed studies, unclear data and ...

RELATED STORY | FDA panel rejects the use of psychedelic drug MDMA to treat patients with PTSD Lykos said the issues FDA raised in what's called a complete response letter echoed the concerns ...

The FDA has denied Lykos Therapeutics' marketing application for its post-traumatic stress disorder (PTSD) therapy based on MDMA, also known as ecstasy, in a setback for the emerging psychedelic ...

“I absolutely agree that we need new and better treatments for PTSD,” Paul Holtzheimer ... An approval by the FDA would mark a major milestone for advocates of MDMA, who contend that ...

A first-of-a-kind proposal to begin using the mind-altering drug MDMA as a treatment for PTSD was roundly criticized Tuesday — a potentially major setback to psychedelic advocates who hope to ...

Multidisciplinary Association for Psychedelic Studies (MAPS), the FDA has agreed study designs for two phase 3 studies assessing MDMA-assisted psychotherapy for patients with severe PTSD.

(MENAFN- Investor Brand Network) Last week, the U.S. Food and Drug Administration (FDA) made the decision not to approve MDMA-assisted therapy for post-traumatic stress disorder. This decision ...

Psychedelic and MDMA-assisted ... treatment with the FDA’s proposed risk evaluation and mitigation strategy (REMS) outweigh its risks for the treatment of patients with PTSD.

An FDA advisory panel voted against recommending the use of MDMA in PTSD therapy. The rejection of Lykos Therapeutics' treatment hurt stocks of firms with similar therapies in development.