Lykos Therapeutics Updates on FDA Meeting for MDMA Therapy for PTSD

SAN JOSE, Calif., June 4, 2024 — Lykos Therapeutics, a firm focused on revolutionizing mental health care, announced that the U.S. Food and Drug Administration's (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) has reviewed their new drug application (NDA) for midomafetamine (MDMA) capsules used alongside psychological interventions to treat post-traumatic stress disorder (PTSD) in adults. The PDAC concluded with a 2-9 vote against the effectiveness and a 1-10 vote against the benefits outweighing the risks of the proposed treatment.

While the FDA will consider PDAC's guidance, it is not obliged to follow it. The final decision on the approval of midomafetamine is expected by August 11, 2024, as per the Prescription Drug User Fee Act (PDUFA) target action date.

Amy Emerson, CEO of Lykos Therapeutics, expressed disappointment over the vote but acknowledged the complexity of evaluating a combined therapeutic approach involving both drug and psychological interventions. Emerson emphasized Lykos's commitment to collaborating with the FDA to resolve outstanding issues and responsibly introduce MDMA-assisted therapy if approved.

The PDAC's evaluation included data from two Phase 3 studies, MAPP1 and MAPP2, which were double-blind, placebo-controlled trials that assessed the efficacy and safety of MDMA combined with psychological intervention. Both studies, published in Nature Medicine, met their primary and secondary endpoints.

Dr. Jerry Rosenbaum, Director of the Center for the Neuroscience of Psychedelics at Massachusetts General Hospital Research Institute, highlighted the significant impact of PTSD on individuals' lives and the importance of identifying new treatment options. He noted that MDMA might enhance psychotherapy by reducing fear responses and enabling individuals to process painful memories more effectively.

In February 2024, the FDA accepted Lykos's NDA for midomafetamine and granted it Priority Review, indicating that the drug could represent a significant improvement over existing treatments for PTSD if approved. Currently, no regulatory agency has approved midomafetamine for PTSD treatment, though it is being investigated for other uses.

PTSD is a severe mental health condition arising from traumatic events, affecting around 13 million Americans annually. Military personnel and marginalized groups are particularly vulnerable. Symptoms include nightmares, intrusive thoughts, and avoidant behaviors, significantly impacting daily life. PTSD often co-occurs with anxiety, depression, substance use disorders, and suicidal ideation, and it can lead to physical health issues such as heart disease and asthma. The economic burden of PTSD in the U.S. is estimated to exceed $232 billion annually.

Current PTSD treatments primarily involve trauma-focused talk therapy and medications like SSRIs (sertraline and paroxetine). However, these treatments often result in high dropout rates and persistent symptoms, highlighting the need for new therapeutic approaches. MDMA, classified as an entactogen, has shown potential in enhancing psychotherapy by allowing patients to access and process traumatic memories without being overwhelmed.

Lykos Therapeutics has been at the forefront of researching MDMA-assisted therapy, conducting rigorous clinical trials to evaluate its efficacy and safety. The company aims to gain FDA approval for this treatment, which would necessitate the rescheduling of MDMA by the DEA, allowing its medical use.

Lykos Therapeutics, a public benefit corporation founded by MAPS, is dedicated to transforming mental healthcare by developing investigational psychedelics to address unmet needs, with a particular focus on PTSD. The company is committed to creating positive impacts on people, communities, and society.

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