The Food and Drug Administration (FDA) has agreed to review MDMA-assisted therapy as a potential treatment option for post-traumatic stress disorder (PTSD), and the application has been granted priority status, according to the psychedelics-focused drug development company that’s leading the effort.
About two months after Lykos Therapeutics (formerly MAPS Public Benefit Corporation) submitted the new drug application (NDA) for MDMA in combination with psychotherapy, FDA granted it priority review last week and has set a target date for determination by August 11, the company announced on Friday.
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 talk therapy and other supportive services.
“Securing priority review for our investigational MDMA-assisted therapy is a significant accomplishment and underscores the urgent unmet need for new innovation in the treatment of PTSD,” Lykos CEO Amy Emerson said in a press release. “We remain focused on working with the FDA through the review process and preparing for a controlled launch with an emphasis on quality should this potential treatment be approved.”
#BREAKING: We are proud to announce the @FDA acceptance and priority review of our new drug application (NDA) filing for our investigational therapy for post-traumatic stress disorder #PTSD in adults. Learn more: https://t.co/WbvgbygG1S pic.twitter.com/v1eHp7XXuQ
— Lykos Therapeutics (formerly MAPS PBC) (@Lykos_PBC) February 9, 2024
Lykos, which was founded as a wholly owned subsidiary of the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS) but last month accepted new investors in conjunction with its name change, 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.
MAPS published the results of a recent Phase 3 trial in the journal Nature last 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.
MAPS President Rick Doblin said in a press release that the organization is “celebrating the therapists and subjects who participated in the Phase 2 and Phase 3 studies and the team at Lykos Therapeutics on the historic accomplishment they have achieved.”
“We hope that potential FDA approval of MDMA-assisted therapy for PTSD is only the first of many psychedelic-assisted therapies that become available by prescription,” he said.
The review that’s now underway is expected to be completed within six months given the expedited application status. That’s four months earlier than a standard NDA review.
An FDA representative told Marijuana Moment on Monday that the agency is “generally unable to discuss existing or potential applications,” citing “confidential commercial information.”
Last year, FDA released first-of-its-kind draft guidance on the “unique” considerations that researchers should take into account when studying psychedelics, which the agency says show “initial promise” as potential therapies.
Shortly after the MDMA capsule NDA was submitted to FDA, new standards from the American Medical Association (AMA) took effect in January that assign psychedelics-specific codes to collect data on the novel therapies.
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.
In 2022, 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 last October that would allow doctors to immediately start prescribing certain currently illicit drugs like psilocybin and MDMA if they’re federally rescheduled.
Last February, Australia legalized MDMA and psilocybin for use by prescription.
Photo courtesy of Pretty Drugthings on Unsplash.