FDA denies approval for MDMA therapy for PTSD

The US FDA has rejected a PTSD treatment based on the psychedelic drug MDMA, developed by Lykos Therapeutics. With the FDA calling for another phase 3 trial, which could take years, Lykos is likely to request a reconsideration. The rejection came despite lobbying for approval and support from bipartisan lawmakers. There have been no new PTSD treatments approved in the US for over 20 years. MDMA, known as ecstasy, has shown potential benefits for conditions like PTSD.