Psychedelic-like drug MDMA inches closer to FDA approval
MDMA, the popular psychedelic-like drug also called “ecstasy” or “molly,” has a storied reputation in underground rave culture but also has a long-established history of clinical use before it was banned in the 1980s. Officially known as 3,4-methylenedioxy methamphetamine, researchers have been exploring its possible effectiveness at treating alcoholism and social anxiety in autism. But for now, MDMA remains highly illegal to possess or sell. Now, the drug may be coming full circle as it inches ever closer to approval from the U.S. Food and Drug Administration.
The biotech company MAPS Public Benefit Corporation (MAPS PBC) is a step closer to official approval for its MDMA-based therapy that supposedly treats post-traumatic stress disorder (PTSD). In a press release, MAPS PBC wrote that the company filed a new drug application (NDA) on Tuesday with the Food and Drug Administration (FDA) to approve MDMA for the first legal treatment of its kind in the United States. The FDA has 60 days to decide on both whether to accept MAPS PBC’s NDA for review and, if so, whether to deem it a priority review (six months) or a standard review (ten months). If approved, MDMA would then have to be rescheduled so it can be available as a prescription medication. MDMA has been a Schedule 1 drug under the Controlled Substances Act since 1985, meaning it has not been available to public for medical use outside of clinical trials.
The proposed therapy uses “a combination of MDMA, psychotherapy (also known as talk therapy) and other supportive services to treat PTSD,” the release stated. A 2021 meta-analysis in the Journal of Clinical Pharmacology found that although “MDMA-assisted psychotherapy has been shown to be an effective therapy for patients with PTSD with a reasonable safety profile, use of unregulated MDMA or use in the absence of a strongly controlled psychotherapeutic environment has considerable risks.”