A psychedelics-focused drug development company is officially asking the Food and Drug Administration (FDA) to review an application to approve MDMA as a prescription medication for the treatment of post-traumatic stress disorder (PTSD).
The MAPS Public Benefit Corporation (MAPS PBC) announced on Tuesday that it submitted the new drug application (NDA) to FDA, requesting an expedited review given that the agency previously designated the psychedelic as a breakthrough therapy.
If the NDA is ultimately approved, the Drug Enforcement Administration (DEA) would then need to reschedule MDMA accordingly. It would become the first psychedelic in history to be approved as a pharmaceutical, to be administered in tandem with psychotherapy and other supportive services.
MAPS PBC, which is a wholly owned subsidiary of the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS), said it provided FDA with copious scientific data derived from multiple clinical trials that supported the efficacy of MDMA as a therapeutic for moderate and severe PTSD.
We are thrilled to share a momentous achievement in our mission to transform mental health care: the submission of the first-ever New Drug Application (NDA) for psychedelic therapy to the FDA!https://t.co/zoMwUahtWv pic.twitter.com/4z7jmd4G9x
— MAPS (@MAPS) December 13, 2023
“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,” Amy Emerson, CEO of MAPS PBC, said in a press release.
“If approved, MDMA-assisted therapy would be the first psychedelic-assisted therapy, which we hope will drive additional investment into new research in mental health,” she said.
MAPS published the results of a recent Phase 3 trial in the journal Nature in September, finding that MDMA “significantly attenuated PTSD symptomology versus placebo with therapy.”
FDA in 2017 designated MDMA as a “breakthrough therapy” based on previous MAPS-sponsored trials. In total, the organization says findings from 18 of its Phase 2 and Phase 3 trials formed the basis of the NDA submitted to FDA.
Because the agency has already recognized the significant therapeutic potential of the psychedelic, MAPS PBC asked it to grant their application a priority review. FDA has 60 days to decided whether it will accept the NDA and whether it will grant priority status for a six-month review or the standards 10-month review.
Meanwhile, a separate study, by researchers at New York University’s Langone Center for Psychedelic Medicine and the Centre for Psychedelic Research at Imperial College London recently found that pairing MDMA with either psilocybin or LSD helped people overcome the “challenging experiences” associated with use of psilocybin or LSD alone.
Last year, the Biden administration said it was “actively exploring” the possibility of creating a federal task force to investigate the therapeutic potential of psilocybin, MDMA and others ahead of the anticipated approval of the substances for prescription use.
In California, meanwhile, Gov. Gavin Newsom (D) signed a bill in October that would allow doctors to immediately start prescribing certain currently illicit drugs like psilocybin and MDMA if they’re federally rescheduled.
In February of this year, Australia legalized MDMA and psilocybin for use by prescription.
Photo courtesy of Pretty Drugthings on Unsplash.