
Advocates for the use of the psychedelic drug MDMA (midomafetamine) to treat mental health conditions were delivered a setback on Friday after the U.S. Food and Drug Administration declined to approve it as treatment for post-traumatic stress disorder (PTSD). There is insufficient evidence that MDMA — currently illegal and also known as Ecstasy or molly — can ease PTSD, the agency told Lykos Therapeutics, a company that’s been seeking to gain approval for the drug’s legitimate use. The FDA asked that Lykos conduct another clinical trial to determine whether MDMA is safe and effective against PTSD — a demand that could mean many years and millions of dollars before another chance at approval would arise. “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 Therapeutics CEO Amy Emerson said in a statement. “While conducting another Phase 3 study would take several years, we still maintain that many of the requests that had been previously discussed with the FDA and raised at the [agency’s] advisory committee meeting can be addressed with existing data, post-approval requirements or through reference to the scientific literature,” Emerson added. Many had… read on > read on >