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The FDA granted breakthrough therapy designation to MDMA-assisted therapy in 2017.
CNN
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The U.S. Food and Drug Administration is being asked to review MDMA (midomaphetamine), the active ingredient in street drugs such as Ecstasy and Molly, and the therapy as a treatment for post-traumatic stress disorder.
MDMA is a hallucinogen known as an entactogen, a type of psychoactive drug that produces feelings of emotional interaction, closeness, and emotional release.
The new application was filed Tuesday by a company called MAPS Public Interest Corporation, which has been researching the drug. in combination with treatment To treat PTSD. The FDA has 60 days to determine whether a new drug application (NDA) is accepted for review and whether the approval process can be expedited.
In 2017, the agency granted breakthrough therapy designation to MDMA-assisted therapy. This designation facilitates the development and review of drugs intended to treat serious conditions and for which preliminary clinical evidence shows the potential to significantly improve available treatments. be.
In two studies with 90 and 104 participants, respectively, MDMA significantly reduced symptoms and functional impairment associated with PTSD compared to a placebo. MAPS announced that it has completed six late-stage clinical trials testing MDMA for PTSD.
“Our NDA filing is the culmination of more than 30 years of clinical research, advocacy, collaboration, and dedication to bring a potential new option to a group of adult patients with PTSD that has seen little innovation in recent decades. ” said MAPS CEO Amy.emerson said in a news release.
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Current treatments for PTSD include antidepressants and some specialized forms of cognitive behavioral therapy. Although these treatments can be beneficial, they are less effective for some people. There is little to help those who do not respond to these options.
If the FDA approves MDMA for this purpose, the schedule would have to change, MAPS said. It is currently a Schedule I drug under the Controlled Substances Act, which the U.S. Drug Enforcement Administration defines as having no currently accepted medical use.
