MDMA Therapy has seen incredible results in the last few years. It has seen the best medical results with PTSD. A recent Phase 3 trial showed significant attenuation of PTSD symptoms compared to placebo. 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” drug approved for pharmaceutical use. This would still require pending DEA rescheduling, something that is not easy to achieve. It took forever to get cannabis even considered for rescheduling by the DEA.
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. FDA has set a date of August 11th for final review.
Lykos Therapeutics has provided extensive clinical trial data demonstrating MDMA’s efficacy in treating moderate to severe PTSD. In 2017, FDA recognized MDMA’s potential by designating it as a “breakthrough therapy.” This could set a precedent for the potential rescheduling and approval of other psychedelic substances, expanding research and treatment options in psychiatric care.