Groundbreaking: FDA Reviews MDMA Therapy For PTSD, Accepts New Drug Application

Three Key Takeaways:

1. FDA Nods to MDMA Therapy Application: The FDA has accepted Lykos Therapeutics’ application for MDMA-assisted therapy for PTSD, marking a significant step in recognizing psychedelic therapies’ medical potential.
2. A Milestone in Psychedelic Research: This development, supported by MAPS’ extensive research, signifies a historical move toward potentially approving MDMA-assisted therapy, which could lead to more psychedelic treatments being accepted.
3. Safety and Efficacy Still Reviewed: Despite the FDA’s priority review, MDMA-assisted therapy’s safety and effectiveness for PTSD are still under scrutiny. The continued investigation reflects a careful approach toward incorporating psychedelic therapies into mental health care.

The U.S. Food and Drug Administration (FDA) has recently accepted a New Drug Application (NDA) from Lykos Therapeutics for the use of MDMA-assisted therapy in treating Post-Traumatic Stress Disorder (PTSD). This decision marks a significant milestone in the journey toward potentially integrating psychedelic-assisted therapies into mainstream medical practice. Lykos Therapeutics, which evolved from the Multidisciplinary Association for Psychedelic Studies (MAPS) Public Benefit Corporation, has been at the forefront of researching this innovative treatment approach. The FDA’s acceptance of the application, backed by over two decades of clinical trial data, underscores the growing interest and recognition of psychedelic substances’ therapeutic potential.

Rick Doblin, Ph.D., the founder and president of MAPS, highlighted the historical significance of this development. He pointed out that the primary motivation behind founding MAPS 38 years ago was to pave the way for psychedelic-assisted therapies to gain FDA approval. The possibility of MDMA-assisted therapy for PTSD becoming available by prescription as early as August 2024 is seen as a potential breakthrough that could open the door for other psychedelic-assisted therapies to become widely accessible to those in need.

The FDA’s decision to grant the application priority review, with a Prescription Drug User Fee Act (PDUFA) target action date set for August 11, 2024, indicates the urgency and importance attributed to this application. This move by the FDA represents a critical step forward in acknowledging the therapeutic benefits that MDMA, a substance historically associated with recreational use and stigmatization, may offer to individuals struggling with PTSD.

It’s important to note, however, that the safety and efficacy of MDMA-assisted therapy for PTSD, as well as other psychedelic-assisted therapies, are still under investigation. Despite the promising developments and the support from extensive research, these treatments have not yet been approved by any regulatory agency for the treatment of any mental health condition. The acknowledgment by both Lykos Therapeutics and MAPS of the ongoing need to establish the safety and efficacy of these treatments reflects a cautious approach to their potential integration into mental health care. This development is a reminder that while significant progress has been made, the journey towards fully understanding and legitimizing psychedelic-assisted therapies in the treatment of mental health conditions continues. Want to keep up to date with all of TDR’s research, subscribe to our daily Baked In newsletter.