Behavioral Health Business August 12, 2024
After years of clinical trials and industry anticipation, the FDA has red-lighted Lykos Therapeutics’ midomafetamine (MDMA)-assisted therapy for treating PTSD.
The agency requested that Lykos conduct an additional Phase 3 trial to further study the therapy’s safety and efficacy. This comes after FDA advisors voted down MDMA therapy in June, saying the treatment lacked data about the risks of the therapy and the efficacy.
“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,” Amy Emerson, CEO of Lykos Therapeutics, said in...
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