The US Food and Drug Administration has been asked to review MDMA, or midomafetamine, the active ingredient in street drugs like ecstasy and molly, along with therapy as a treatment for post-traumatic stress disorder.
MDMA is a psychedelic drug known as an entactogen, a class of psychoactive drugs that produce experiences of emotional communion, relatedness and emotional openness.
The new application was filed Tuesday by a company called the MAPS Public Benefit Corporation, which has been studying the drug in combination with therapy to treat PTSD. The FDA has 60 days to determine whether the new drug application, or NDA, will be accepted for review and whether it will be fast-tracked through the approval process.
In 2017, the agency granted MDMA-assisted therapy a breakthrough therapy designation, a status that expedites the development and review of drugs that are intended to treat a serious condition and that preliminary clinical evidence indicates may be a substantial improvement over available therapies.
In two studies, with 90 and 104 participants respectively, MDMA significantly reduced symptoms and impairment associated with PTSD compared with a placebo. MAPS says it has completed six late-stage clinical trials testing MDMA for PTSD.
“The filing of our NDA is the culmination of more than 30 years of clinical research, advocacy, collaboration and dedication to bring a potential new option to adults living with PTSD, a patient group that has experienced little innovation in decades,” 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, for some, they are only modestly effective. There’s been little to help people who don’t respond to these options.
If the FDA approves MDMA for this purpose, it would need to be rescheduled, MAPS says. It’s currently a schedule I drug under the Controlled Substances Act, which the US Drug Enforcement Administration defines as having no currently accepted medical use.
