FDA denies approval of MDMA-assisted therapy for PTSD

The US Food and Drug Administration has denied approval of MDMA-assisted therapy for post-traumatic stress disorder despite overwhelming evidence of the safety and efficacy of this treatment. The FDA requested another Phase 3 trial of the treatment.

"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," said Amy Emerson, CEO of Lykos, the drug development public benefit company developing the therapy. — Read the rest

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