An organization that’s been conducting clinical trials on MDMA therapy has filed a new drug application with the Food and Drug Administration that would make the drug legal for treating post-traumatic stress disorder if approved.
The Multidisciplinary Association for Psychedelic Studies Public Benefit Corporation (MAPS PBC), a company that promotes the regulation of psychedelics, said Tuesday it filed the application for MDMA capsules which would be used in conjunction with psychotherapy or talk therapy and other supportive services.
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If approved by the FDA, MDMA would be rescheduled by the Drug Enforcement Agency so that it could be prescribed. MDMA is currently a Schedule I drug under the Controlled Substances Act, meaning the government believes “it has a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision.”
“The filing of our (new drug application) 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,” said Amy Emerson, chief executive officer of MAPS PBC, in the announcement.
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The FDA has 60 days to decide if it will review the application and whether it will be a priority or a standard review, which take six and 10 months, respectively.
MAPS PBC completed two Phase-3 clinical trials on MDMA therapy. Results from the first Phase 3 study, published in Nature, showed 88 percent of participants with severe PTSD experienced “a clinically significant reduction in PTSD diagnostic scores” after three sessions compared to 60 percent of placebo participants. Of 1,700 participants who were given MDMA, only one had an adverse reaction, according to MAPS PBC.
While ketamine-assisted therapy clinics have ballooned around the country, ketamine is not approved by the FDA for therapeutic purposes. It is a legal anesthetic that’s prescribed for mental health conditions off label.
