FDA Advisory Committee to Review Lykos Therapeutics’ MDMA Therapy for PTSD

Lykos Therapeutics is seeking FDA approval for its midomafetamine capsules as a treatment for post-traumatic stress disorder (PTSD). The FDA’s Psychopharmacologic Drugs Advisory Committee will review this proposal in a meeting set for June 4, 2024. This meeting is notable as it marks the first time in 25 years that the advisory committee will evaluate a potential new PTSD therapy. 

The investigational therapy is also significant because it includes MDMA, known scientifically as 3,4-methylenedioxymethamphetamine, which is often referred to as ecstasy. MDMA is a Schedule I drug, which means it has tight restrictions due to its psychoactive properties. However, Lykos aims to harness its therapeutic potential when combined with psychotherapy and other supportive mental health services for PTSD patients.

The New Drug Application (NDA) for this MDMA-assisted therapy was accepted by the FDA in February 2024. The application is supported by data from several studies, notably the Phase III MAPP1 and MAPP2 trials. Both trials assessed the efficacy of MDMA-assisted therapy using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), which is a key measurement tool for PTSD symptoms. Secondary endpoints included functional improvement metrics.

MAPP1 focused on patients with severe PTSD and found a significant reduction in CAPS-5 scores compared to a placebo. This study, published in Nature Medicine in 2021, also showed marked improvement in patient functionality as measured by the Sheehan Disability Scale. MAPP2, which enrolled patients with moderate-to-severe PTSD, yielded similar results with significant improvements in both CAPS-5 scores and functional performance.

The overall tolerability of the MDMA-assisted therapy was favorable in both studies, with no reported deaths or serious adverse events related to the treatment. 

The FDA is expected to make its decision by August 11, 2024. The advisory committee meeting and subsequent FDA decision are critical as psychedelics are gaining traction in the biopharma industry. For instance, Reunion Neuroscience recently raised $103 million to advance its psilocybin-derivate therapy for postpartum depression. Similarly, MindMed’s LSD-based treatment received the FDA’s breakthrough designation following positive Phase IIb data, and Incannex reported strong Phase II results for its psilocybin-based treatment for generalized anxiety disorder.

In January 2024, the MAPS Public Benefit Corporation rebranded as Lykos Therapeutics after securing $100 million in a Series A funding round. This rebranding and financial boost underscore the growing interest and investment in psychedelic-assisted therapies.

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