Lykos Therapeutics Unveils New Oversight Plans for Midomafetamine Therapy Pending FDA Approval

Lykos Therapeutics, a company committed to revolutionizing mental healthcare, has announced initiatives geared towards the potential commercial launch and thorough oversight of midomafetamine-assisted therapy for treating post-traumatic stress disorder (PTSD) in adults. This initiative comes in anticipation of approval from the U.S. Food and Drug Administration (FDA). The company's New Drug Application (NDA) incorporates results from comprehensive studies, particularly two Phase 3 trials, MAPP1 and MAPP2, which evaluated the efficacy and safety of midomafetamine-assisted therapy against a placebo. Published in the prestigious journal Nature Medicine, both studies met their primary and secondary endpoints.

Lykos Therapeutics’ NDA is groundbreaking in that it uniquely combines a medicinal drug with psychological intervention, a first of its kind. While psychotherapy remains a regulated field with mandatory reporting and oversight, healthcare professionals administering midomafetamine-assisted therapy will employ their clinical expertise, compliant with existing regulatory requirements and further controls outlined in the product labeling and the Risk Evaluation and Mitigation Strategy (REMS) program.

Amy Emerson, CEO of Lykos Therapeutics, emphasized the necessity of integrating this new treatment modality into the existing healthcare framework, especially for the millions of PTSD sufferers, including veterans and assault survivors. To this end, the company plans to collaborate with an independent advisory board, initially roll out the treatment at centers with robust oversight, and coordinate therapy training with other institutions.

Key measures for additional oversight include setting up an independent advisory board featuring experts in medical ethics, innovation, psychiatry, and military health. Notable members include Barbara O. Rothbaum, Ph.D., Professor of Psychiatry at Emory University, and Brigadier General (Ret) Loree Sutton, M.D., among others. Lykos aims to partner with leading behavioral health centers that meet FDA and Drug Enforcement Administration (DEA) requirements. These facilities, such as Emory University, Sheppard Pratt, and Hackensack Meridian Health, are expected to be among the first to offer midomafetamine-assisted therapy if it gains FDA approval.

Furthermore, Lykos is engaging with other institutions to leverage their clinical trial experience for developing MDMA-assisted therapy, aligning with external perspectives to support the training needs of institutions planning to provide this new treatment. This collaboration aims to ensure that therapist training is adequately supported and delivered effectively.

Dr. Rothbaum endorsed the initiative, underscoring the importance of providing PTSD patients with effective treatments and preparing centers to lead in offering this promising therapy. Currently, the safety and efficacy of midomafetamine for PTSD treatment have not been fully established, and the drug remains under investigation for other indications. Should the FDA approve it, a REMS program will be mandated to manage and mitigate potential risks associated with its use.

PTSD is a serious condition affecting millions annually, with higher prevalence among women, marginalized groups, and military personnel. The debilitating symptoms can significantly impact a person's life and lead to co-morbidities such as anxiety, depression, and substance use disorders. The economic burden of PTSD in the U.S. is substantial, with annual costs exceeding $232 billion.

The primary treatment for PTSD includes trauma-focused talk therapy, sometimes combined with medication. While some treatments exist, many patients do not respond sufficiently or drop out early, highlighting the urgent need for new, evidence-based therapies. Despite advancements in PTSD management, no new drug treatments have been approved by the FDA in over two decades. Midomafetamine (MDMA) has been studied for its potential to enhance psychotherapy by allowing patients to process painful memories more effectively. Recognized for its historical use in psychotherapy during the 1970s and early 1980s, MDMA's potential in modern therapy is supported by recent research advocating its benefits in treating PTSD.

Lykos Therapeutics, a public benefit corporation founded by the Multidisciplinary Association for Psychedelic Studies (MAPS), is dedicated to applying extensive research to develop innovative therapies for mental health conditions, with a primary focus on PTSD.