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The FDA granted breakthrough therapy designation to MDMA-assisted therapy in 2017.
CNN –
The U.S. Food and Drug Administration has been asked to review MDMA, or midomafetamine, the active ingredient in street drugs like Ecstasy and Molly, along with the therapy used to treat post-traumatic stress disorder.
MDMA is a psychedelic drug known as an entactogen, a class of psychoactive drugs that produce experiences of emotional community, connection, and emotional openness.
The new application was filed Tuesday by a company called MAPS Public Benefit Corporation, which is studying the drug in combination with therapy to treat PTSD. The FDA has 60 days to decide whether to accept the new drug application (NDA) for review and whether to expedite the approval process.
In 2017, the agency granted MDMA-assisted therapy breakthrough therapy designation, a designation that expedites the development and testing of drugs to treat a serious condition and preliminary clinical evidence suggests they may represent a significant improvement over available therapies .
In two studies involving 90 and 104 participants, MDMA significantly reduced symptoms and impairments associated with PTSD compared to a placebo. MAPS says it has completed six late-stage clinical trials testing MDMA for PTSD.
“The submission of our NDA is the culmination of more than 30 years of clinical research, advocacy, collaboration and commitment to provide a potential new option to adults with PTSD, a patient population that has seen little innovation in decades,” said Amy, CEO of MAPS, Emerson said in a press release.
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Current treatments for PTSD include antidepressants and some specific forms of cognitive behavioral therapy. Although these treatments can be beneficial, they are only moderately effective for some. There was little help for the people who did not respond to these options.
If the FDA approves MDMA for this purpose, the date would have to be postponed, MAPS says. It is currently a Schedule I drug under the Controlled Substances Act and, as defined by the U.S. Drug Enforcement Administration, has no current recognized medical use.