FDA Grants Priority Review to New MDMA-Assisted Therapy for PTSD

The U.S. Food and Drug Administration (FDA) has recently taken a significant step towards approving a groundbreaking new treatment for post-traumatic stress disorder (PTSD). The agency has accepted a New Drug Application (NDA) for midomafetamine (MDMA) capsules to be used in conjunction with psychological interventions for individuals diagnosed with PTSD. The treatment is expected to have a significant impact on the mental health community, especially among veterans who are at a higher risk for suicide due to PTSD.

MDMA-Assisted Therapy: A Potential Gamechanger for PTSD Treatment

In a landmark decision, the FDA has granted Priority Review status to the NDA submitted by Lykos Therapeutics, formerly known as MAPS Public Benefit Corporation. Midomafetamine, a medicinal formulation of MDMA, better known as ecstasy, has shown promising results in alleviating the symptoms of PTSD when used in a controlled clinical setting. The decision to grant Priority Review status is a clear indication of the FDA's recognition of the potential benefits of MDMA-assisted therapy.

The NDA submission was supported by the results from two rigorous Phase 3 clinical trials, MAPP1 and MAPP2. These studies evaluated the efficacy and safety of MDMA-assisted therapy versus placebo with therapy among patients diagnosed with severe or moderate-to-severe PTSD. The results were promising, with both studies meeting their primary endpoint of changes in PTSD severity from baseline and their key secondary endpoint of improvement in functional impairment. Notably, no serious adverse events were reported in the MDMA group in either study.

Implications for the Future

If approved, this will be the first-ever MDMA-assisted therapy and psychedelic-assisted therapy for PTSD. This represents a significant breakthrough in the field of mental health, and may pave the way for a new era of treatment options for individuals suffering from PTSD and other mental health conditions. The FDA has set a Prescription Drug User Fee Act target action date for August 11, 2024.

This development has been lauded by numerous stakeholders in the healthcare and wellness community. Canadian wellness company Numinus Wellness Inc. congratulated Lykos Therapeutics on this milestone and pledged continued support for the administration of MDMA-assisted therapy, as they are currently doing under regulatory exceptions in their Canadian clinics. Furthermore, psychedelic research organizations such as the Multidisciplinary Association for Psychedelic Studies also celebrated the FDA's decision.

Psychedelic Therapies and Veterans

The potential approval of MDMA-assisted therapy carries significant implications for the veteran community. Veterans with PTSD are at a higher risk for suicide than those without the diagnosis, with PTSD diagnoses prevalent among 25% of veterans who died from suicide in 2020. Rep. Morgan Luttrell, R-Texas, a former Navy SEAL, has credited psychedelic-assisted therapy for helping address his PTSD and other mental health problems post-service. The VA recently announced plans to fund clinical trials of psychedelic-assisted therapies using magic mushrooms and ecstasy to treat PTSD.

With the FDA's decision to review the use of MDMA-assisted therapy for PTSD, we could be witnessing the dawn of a new era in mental health treatment. It's an exciting time, and we'll be watching closely as the FDA's target action date in August 2024 approaches.