FDA grants quick review for 3 psychedelic drug trials for major depression and PTSD, including psilocybin and a methylone-like drug

FDA granted a quick review for three experimental psychedelic drug trials targeting major depression and post-traumatic stress disorder. The priority review is tied to the FDA accelerated priority voucher program, which can shorten review time from months to a few months. FDA did not name the companies receiving priority vouchers, but it signaled that psilocybin applications are expected for major depression or treatment-resistant depression, while a company is investigating methylone, a compound similar to MDMA, for PTSD. FDA commissioner Marty Makary said the treatments could help address the mental health crisis, including treatment-resistant depression. Experts welcomed scientific scrutiny and emphasized the need to determine who benefits and who does not, along with safety risks. The FDA action also allows U.S. research on a derivative of ibogaine, noribogaine hydrochloride, as a potential alcohol use disorder treatment, with noribogaine reported to avoid the intense long ibogaine high.