FDA Committee to Review Lykos Therapeutics' MDMA Therapy for PTSD

Lykos Therapeutics, a company focused on revolutionizing mental healthcare, has announced an upcoming milestone. On June 4, 2024, the U.S. Food and Drug Administration's (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) will review the New Drug Application (NDA) for midomafetamine (MDMA) capsules used alongside psychological interventions for treating adults with post-traumatic stress disorder (PTSD). This marks the first time in 25 years that an FDA advisory committee will consider a new treatment for PTSD.

Amy Emerson, CEO of Lykos Therapeutics, remarked on the significance of this event, highlighting it as the first review of MDMA-assisted and psychedelic-assisted therapy by the PDAC. She emphasized that this milestone is the result of many years of clinical research and advocacy. The company looks forward to discussing the comprehensive data supporting the investigational use of MDMA, and if approved, how it might be prescribed in combination with psychological interventions for adults suffering from PTSD.

PDAC will evaluate findings from several studies, including two major randomized, double-blind, placebo-controlled Phase 3 trials known as MAPP1 and MAPP2. These studies assessed the efficacy and safety of MDMA in combination with psychological interventions, including psychotherapy and other supportive services, versus placebo with psychological interventions. Participants in these trials were diagnosed with either severe or moderate to severe PTSD. Both studies successfully met their primary and secondary endpoints and were published in the journal Nature Medicine.

In February 2024, the FDA accepted Lykos Therapeutics' NDA for midomafetamine combined with psychological intervention for PTSD treatment. The application was granted Priority Review, a designation that accelerates the review process for drugs that could significantly improve treatment outcomes for serious conditions. The FDA set a target action date of August 11, 2024, under the Prescription Drug User Fee Act (PDUFA). If approved, this would be the first MDMA-assisted and psychedelic-assisted therapy available for clinical use.

It is important to note that midomafetamine (MDMA) capsules have not yet received approval from any regulatory agency, and their safety and efficacy for treating PTSD have not been fully established. Besides PTSD, investigational midomafetamine is being studied for other potential indications.

Lykos Therapeutics was founded by MAPS as a public benefit corporation (PBC). The company is committed to transforming mental healthcare by harnessing decades of evidence-based research to develop innovative psychedelic therapies for mental health conditions. Lykos is dedicated to addressing unmet needs in mental health, with an initial focus on PTSD. As a PBC, Lykos aims to deliver positive societal impact through its work.

This upcoming FDA advisory committee meeting represents a potentially groundbreaking development in the treatment of PTSD and could pave the way for new therapeutic options for those affected by this debilitating condition.