According to the psychedelics drug development company leading the effort, the FDA has granted MDMA-assisted treatment priority status and agreed to evaluate it as a possible treatment for post-traumatic disorder (PTSD).
Lykos Therapeutics, formerly MAPS Public Benefit Corporation, submitted its new drug application for MDMA combined with psychotherapy about two months ago. FDA gave it priority last week and set an August 11 deadline for a final determination.
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 talk therapy and supportive services.
In a press statement, Amy Emerson , CEO of Lykos, said that “securing priority review for the investigational MDMA assisted therapy is a significant achievement and highlights the urgent need for new innovations in the treatment for PTSD.” We remain committed to working with FDA throughout the review process, and we are preparing for a managed launch that places an emphasis on the quality of the treatment if it is approved.
#BREAKING We are pleased to announce that the FDA has accepted and given priority review for our investigational treatment for post-traumatic anxiety disorder #PTSD for adults. Learn more: https://t.co/WbvgbygG1S pic.twitter.com/v1eHp7XXuQ
Lykos Therapeutics, formerly MAPS PBC (@Lykos_PBC), February 9, 2020
Lykos, a wholly-owned subsidiary of the nonprofit Multidisciplinary Association for Psychedelic Studies, but which last month welcomed new investors to coincide with its name change provided FDA with a wealth of scientific data derived by multiple clinical trials, supporting the efficacy and effectiveness of MDMA in treating moderate or severe PTSD.
MAPS reported the results of a Phase 3 trial published in Nature by MAPS , last September. The study found that MDMA significantly reduced PTSD symptoms compared to placebo therapy.
In 2017, FDA designated MDMA as “breakthrough therapy”, based on trials sponsored by MAPS. The organization claims that findings from 18 of their Phase 2 and Phase 3 studies formed the basis for the NDA it submitted to FDA.
MAPS President Rick Doblin stated in a release that MAPS “celebrates the therapists, subjects and team at Lykos therapeutics for the historic achievement they have achieved.”
“We hope the potential FDA approval for MDMA-assisted treatment for PTSD will be only the first of many psychedelic assisted therapies that are available on prescription,” he stated.
A review of the application that is currently underway should be completed in six months, given its expedited status. This is four months sooner than the standard NDA review.
A representative of the FDA told Marijuana Moment Monday that, citing “confidential information” about commercial applications, they are “generally not able to discuss current or potential applications.”
The FDA published a draft guidance document on last year. It was the first of its kind. It outlined the “unique considerations” that researchers must take into account in studying psychedelics. According to the FDA, these drugs show “initial potential” as possible 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.
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 recent study that combining MDMA with psilocybin, or LSD, helped people overcome “challenging” experiences related to the use of psilocybin alone.
In 2022 the Biden administration stated 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, Gov. Gavin Newsom, a Democrat from California, signed a law in October last year that allows doctors to prescribe certain drugs currently illegal like MDMA and psilocybin as soon as they are federally rescheduled.
In February of this year, Australia made MDMA and Psilocybin available by prescription.
Pennsylvania Governor says lawmakers ‘don’t even have a choice’ but to legalize marijuana as other states move ahead
Photo by Pretty Drugthings via Unsplash.
The post FDA Gives Priority To MDMA-Assisted Treatment For PTSD, Psychedelics Drug Development Company Said appeared initially on Marijuana Moment.
