MDMA Therapy For PTSD Closer To Legality As Key FDA Approval Meeting Approaches, Sparking Hope And Controversy

MDMA, the drug commonly known as ecstasy and declared illegal by the DEA in 1985, is nearing a landmark moment in its journey toward becoming a legal and approved treatment for PTSD. Lykos Therapeutics Inc., a company that emerged from the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS), has spearheaded this effort, bringing the first new PTSD treatment in over two decades to the brink of FDA approval.

FDA Review And Potential Approval Timeline

On Tuesday, the FDA's Psychopharmacologic Drugs Advisory Committee will meet to discuss the drug application submitted by Lykos, providing the first clear indication of the FDA’s stance on this treatment and possibly paving the way for a final decision by August. According to Bloomberg, the treatment involves administering MDMA in conjunction with 42 hours of therapy, a method aimed at addressing the deep-seated trauma experienced by PTSD patients which has shown promising results in clinical trials.

As the FDA nears a decision on MDMA for PTSD treatment, it’s crucial to stay informed about the implications for the future of psychedelic medicine. Hear directly from top experts, researchers, and policymakers at the 19th Benzinga Cannabis Capital Conference, coming to Chicago this Oct. 8-9. Get your tickets now before prices surge by following this link.

Controversies And Concerns Raised By ICER

While Lykos, supported by high-profile donors and a recent $100 million investment, is confident in the therapy's potential, the journey has not been without controversy. The Institute for Clinical and Economic Review (ICER) recently issued a report raising concerns about the validity of Lykos’ trial results, questioning the reliability of non-blind trials and the potential for bias.

Additionally, the report cited instances of alleged misconduct and underreporting of adverse effects, leading to a near-unanimous vote from ICER advisers against the proven benefit of MDMA-assisted therapy compared to standard talk therapy.

Urgent Need For Effective PTSD Treatments

Despite these concerns, the urgency for new and effective PTSD treatments is undeniable. Current medications often fall short though MDMA’s phase three trials showed substantial symptom reduction in two-thirds of participants, noted Bloomberg. “We’re on the precipice of integrating psychedelic medicine into mainstream medicine,” Lykos chairman Jeff George said at a recent conference.

Highlighting the treatment’s potential impact, the Department of Veterans Affairs, managing a vast PTSD patient population, is already preparing to adopt the treatment if approved. Former Army Ranger Jesse Gould, who leads a nonprofit assisting veterans with PTSD called Heroic Hearts Project emphasized the critical need for effective treatments. “If not MDMA, there's nothing out there in the pipeline,” he stated. Yet, ICER's outside advisers caution against hastily embracing MDMA therapy without addressing the raised concerns fully.

Challenges Ahead For MDMA Legalization And Accessibility

Even if the FDA grants approval, MDMA's legalization faces further challenges, including DEA rescheduling and ensuring therapists receive specialized training. Furthermore, the therapy’s high cost, estimated by ICER at over $12,000 per patient, might deter insurance coverage and pose additional barriers to its widespread adoption.

Photo: Benzinga edit with photo by Yuriy Golub and Bacsica on Shutterstock.