The FDA on Friday granted quick review of three experimental psychedelic drugs meant to treat major depression and post-traumatic stress disorder. The move signals a shift in policy toward treatments that produce psychoactive effects, coming as the Justice Department eases restrictions on state-licensed medical marijuana.
Priority Voucher Awards
Two unnamed companies are expected to submit applications for psilocybin to treat either major depression or depression resistant to standard treatments, while another company investigates methylone, similar to MDMA, for PTSD. FDA Commissioner Marty Makary stated the medications “have the potential to address the nation’s mental health crisis, including conditions like treatment resistant depression, alcoholism and other serious mental health and substance abuse conditions.”
Timeline and Ibogaine Research
The accelerated application process could allow the FDA to potentially approve the first psychedelic drug by the end of summer, according to Makary. The FDA also permitted researchers to study noribogaine, a derivative of ibogaine derived from the African Tabernanthe iboga shrub, as a potential treatment for alcohol use disorder. Miami-based drug company DemeRx NB will research noribogaine hydrochloride. Nearly 28 million Americans have alcohol use disorder, affecting roughly 1 in 10, according to the National Institute on Alcohol Abuse and Alcoholism. Noribogaine reportedly does not produce the intense, hours-long, and sometimes emotionally upsetting high associated with ibogaine itself.
This article is an AI-assisted summary. All facts and figures are drawn from the original report: https://us.headtopics.com/news/fda-grants-quick-review-for-3-psychedelic-drug-trials-82631351