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The MAPS Public Benefit Corporation (MAPS PBC), a psychedelics-focused, drug-development company, has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA). MAPS PBC is asking the FDA to approve the use of MDMA (ecstasy, molly) as a prescription medication for treating post-traumatic stress disorder (PTSD). The company is requesting that the federal agency provide an expedited review of the psychedelic as the FDA had already designated it as a breakthrough therapy.
The FDA granted breakthrough therapy designation for MDMA in PTSD treatment in 2017 and reached an agreement with MAPS to design two MDMA phase 3 trials (MAPP1 and MAPP2) under the Special Protocol Assessment Process (SPA). MAPS Public Benefit Corporation has spent the past several years studying MDMA-assisted psychotherapy to treat severe PTSD and has generated encouraging results in its pair of phase 2 trials.
If the FDA approves the new drug application for MDMA, the Drug Enforcement Administration (DEA) would have to reschedule the psychedelic in tandem, making it the first hallucinogen in history to receive approval for use as a pharmaceutical.
Multidisciplinary Association for Psychedelic Studies (MAPS), the nonprofit that wholly owns MAPS PBC, has reportedly completed six late-stage clinical trials. MAPS CEO Amy Emerson said the recently filed NDA was the culmination of more than three decades of clinical research, collaboration, dedication and advocacy focused on developing a potentially new treatment option for American adults living with post-traumatic stress disorder.
Studies from MAPS and other institutions have found that MDMA-assisted therapy can be incredibly effective at offering long-term relief against PTSD with barely any negative side effects.
According to MAPS PBC, it provided the FDA with substantial scientific data collected from several clinical tests that show MDMA can be effective at treating moderate to severe PTSD. Results from a MAPS phase 3 trial published in the journal “Nature” in September state that the psychedelic “significantly attenuated PTSD symptomology.”
Adults with PTSD currently use treatments such as antidepressants and cognitive behavioral therapy, but these treatments are only modestly effective. In addition, they often come with a variety of side effects. Additionally, PTSD patients who don’t respond to conventional therapies often do not have alternative options for treatment.
Psychedelics such as MDMA present an opportunity for these individuals to finally gain long-term relief from the debilitating condition that is PTSD with little to no side effects to their health and well-being.
The FDA now has 60 days to decide whether it will approve the NDA. The success of this NDA is likely to be celebrated by the entire psychedelics industry, including major companies such as atai Life Sciences N.V. (NASDAQ: ATAI) since it will be a major milestone that finally brings psychedelics into the mainstream medical field.
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