John Schroyer
One of the leading psychedelics industry’s research organizations, the Multidisciplinary Association for Psychedelic Studies, has at long last filed its formal New Drug Application with the U.S. Food and Drug Administration, the final step before many of the 13 million post-traumatic stress disorder patients in the U.S. can start being treated with MDMA.
The application was filed by the MAPS Public Benefit Corp. and is the first-ever submission to the FDA for a psychedelic-assisted therapy regimen, according to a statement from MAPS.
It’s also a step MAPS has been working toward for years.
“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,” Amy Emerson, CEO of the MAPS PBC, said in the statement.
Emerson said she also hopes that the application, if approved, will drive more investment into further research on medical applications of various psychedelics.
The application itself was for MDMA to be utilized “in combination with psychological intervention, which includes psychotherapy, or talk therapy,” along with possibly other therapies from certified healthcare providers.
The FDA now has 60 days to determine whether the application will be accepted for review. If it is, the application could be granted in as little as six months, but could take up to 10 months, meaning it could easily be another year until MAPS is able to bring the MDMA treatment to market.
If the application is ultimately successful, it would also require the FDA to reschedule MDMA from a Schedule I narcotic to a lower level that allows physicians to prescribe the drug.
The two MDMA therapies that underwent clinical trials by MAPS PBC had “no adverse events” among test subjects and both “met the primary endpoint” in the medical studies. MAPS PBC finished six Phase 2 and two Phase 3 clinical studies, and findings were previously published in the journal Nature Medicine.
“Today is a historic day for health care in the United States,” Cody Shandraw, managing partner of Ambria Capital and the president of Healing Realty Trust, said in a press release. “MDMA-assisted therapy represents a new day in how mental and behavioral health is treated in our country and we applaud the entire MAPS organization.”
Shandraw noted that there’s still a lot of work to be done, however, to adapt the health care infrastructure so as to make psychedelic treatments accessible in coming years to patients, which will likely include:
- Training professionals in psychedelic therapies.
- Opening more treatment clinics.
- Getting even more psychedelic treatments approved by the U.S. federal government.
