FDA Advisory Committee to Review Lykos Therapeutics’ MDMA-Assisted Therapy in Early June

Save the date: the FDA will hold an advisory committee meeting to review Lykos Therapeutics’ New Drug Application (NDA) for MDMA-assisted psychotherapy in the treatment of PTSD on June 4th, 2024.

The purpose of FDA advisory committees is to provide “independent, expert advice” to the agency [1]. In this case, it will be the agency’s Psychopharmacologic Drugs Advisory Committee (PDAC) that is tasked with reviewing Lykos’ data package and considering how the investigational treatment might be used in practice.

PDAC’s nine core voting members include UCLA Assistant Clinical Professor of Psychiatry Walter S. Dunn, the Ottawa Hospital’s Department of Mental Health Chief, Jess G. Fiedorowicz, and a psychiatry integrative holistic medicine practitioner, Sonia L. Krishna (whose practice name is Mind Medicine PLLC, not to be confused with Mind Medicine Inc., or MindMed!).

Growing Public and Practitioner Pressure for Novel PTSD Therapies

The last FDA advisory committee meeting to review a potential PTSD treatment took place before the turn of the century, in October 1999. That meeting was tasked with evaluating whether the antidepressant, Zoloft (sertraline), should be approved for use in PSTD. FDA approved the drug for PTSD later that year.

Given this lapse in new treatment options—seen across the mental health field—there’s certainly growing interest among the public, patients and practitioners for additions to the armamentarium.