The FDA has initiated a priority review of MDMA-assisted therapy as a potential treatment for PTSD, as announced by Lykos Therapeutics. This significant step could lead to MDMA becoming the first psychedelic approved for pharmaceutical use, pending DEA rescheduling.
The Food and Drug Administration (FDA) has taken a pivotal step by agreeing to review MDMA-assisted therapy for post-traumatic stress disorder (PTSD), granting it priority status. This decision comes approximately two months after Lykos Therapeutics, previously known as MAPS Public Benefit Corporation, submitted a new drug application (NDA) for the combination of MDMA and psychotherapy. The FDA’s priority review, with a determination target date set for August 11, highlights the urgency and potential of this innovative treatment approach.
Lykos Therapeutics, a subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS), has provided extensive clinical trial data demonstrating MDMA’s efficacy in treating moderate to severe PTSD. The results of a recent Phase 3 trial, published in Nature, showed significant attenuation of PTSD symptoms with MDMA therapy compared to placebo. The FDA had previously recognized MDMA’s potential by designating it as a “breakthrough therapy” in 2017, based on earlier MAPS-sponsored trials.
The ongoing review process is expedited, expected to conclude within six months, underscoring the FDA’s recognition of the need for new PTSD treatments. If approved, the Drug Enforcement Administration (DEA) would need to reschedule MDMA to allow its prescription use in conjunction with psychotherapy and other supportive services.
Why It Matters: The FDA’s decision to prioritize the review of MDMA-assisted therapy for PTSD represents a critical advancement in the field of mental health treatment. Approval could pave the way for the first psychedelic drug to be prescribed, offering new hope for individuals with PTSD. This development also reflects the growing acceptance and interest in the therapeutic potential of psychedelics.
Potential Implications: Approval of MDMA-assisted therapy could revolutionize PTSD treatment, providing an effective alternative for those who have not benefited from existing therapies. It also sets a precedent for the potential rescheduling and approval of other psychedelic substances, expanding research and treatment options in psychiatric care.
Source: Marijuana Moment
