FDA denies approval for MDMA therapy for PTSD

(The Hill) — The Food and Drug Administration (FDA) on Friday denied approval of an MDMA-based treatment for post-traumatic stress disorder (PTSD), the manufacturer said, a major setback for the use of psychedelic drugs as medicine.

Drug company Lykos Therapeutics said the FDA told them the treatment "could not be approved based on data submitted to date."

Lykos said the FDA has requested an additional Phase 3 trial to further study the safety and efficacy of the treatment, but such studies often take years. The company said it plans to request a meeting with the FDA to ask for reconsideration.

"The FDA request for another study is deeply disappointing, not just for all those who dedicated their lives to this pioneering effort, but principally for the millions of Americans with PTSD, along with their loved ones, who have not seen any new treatment options in over two decades," Lykos CEO Amy Emerson said in a statement.

The decision was widely expected after an independent FDA advisory panel overwhelmingly recommended against approving the treatment, which paired MDMA, commonly known as ecstasy, with talk therapy t...