The FDA has been officially asked by a psychedelic drug company to review a request to approve MDMA for prescription treatment of posttraumatic stress disorder (PTSD).
MAPS Public Benefit Corporation announced Tuesday that they had submitted a new drug application to FDA. They requested an expedited review, as the FDA previously classified the psychedelics as a breakthrough treatment.
The Drug Enforcement Administration (DEA), if the NDA were to be approved, would have to reschedule MDMA. It would be the first time in history that a psychedelic was approved as a drug, administered along with psychotherapy or other supportive services.
MAPS PBC is a fully owned subsidiary of Multidisciplinary Association for Psychedelic Studies, a nonprofit organization. MAPS PBC said that it had provided FDA with a large amount of scientific data derived through multiple clinical trials which supported MDMA’s efficacy as a treatment for moderate to severe PTSD.
In a press statement, Amy Emerson, CEO at MAPS PBC , said that the filing of their NDA was the culmination more than 30 years’ worth of clinical research, advocacy and collaboration to bring a potentially new option to adult patients living with PTSD.
She said that if approved, MDMA assisted therapy would be a first in psychedelic-assisted therapies, and we hope this will lead to additional investments into new mental health research.
MAPS reported the results of a Phase 3 trial published in Nature by MAPS , in September. The study found that MDMA significantly reduced PTSD symptoms compared to placebo therapy.
In 2017, FDA designated MDMA as ” breakthrough treatment” on the basis of previous MAPS sponsored trials. The organization claims that findings from 18 of their Phase 2 and Phase 3 clinical trials were the basis for the NDA they submitted to FDA.
MAPS PBC requested a priority review because the agency had already acknowledged the therapeutic potential of psychedelics. FDA has 60 calendar days to decide whether or not it will accept an NDA, and if it will give priority status for either a 6-month review or a 10-month standard review.
Researchers at the Langone Center for Psychedelic Medicine at New York University and the Centre for Psychedelic Research of Imperial College London found in a separate study that pairing MDMA or psilocybin with LSD or psilocybin helped people overcome “challenging” experiences when using psilocybin alone.
The Biden administration stated last year that it was “actively examining” the possibility to create a federal taskforce to investigate the therapeutic potency of psilocybin and MDMA, among others, ahead of anticipated approval of these substances for prescription use.
In California, meanwhile Gov. Gavin Newsom, a Democrat from California, signed a law in October allowing doctors to immediately begin prescribing certain drugs that are currently illegal like MDMA and psilocybin once they were federally rescheduled.
Australia has legalized MDMA, psilocybin and their use on prescription.
New Hampshire lawmakers have already pre-filed a dozen marijuana bills for the 2024 session
Photo by Pretty Drugthings via Unsplash.
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