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MDMA Therapy for PTSD Receives “No” Vote From FDA Advisory Committee

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The Psychopharmacologic Drugs Advisory Committee (PDAC), a key advisory panel to the US Food and Drug Administration (FDA), has reached a decision regarding the effectiveness of midomafetamine (MDMA) capsules – used in combination with psychological intervention – for the treatment of post-traumatic stress disorder (PTSD).

According to a press release from Lykos Therapetics, which submitted a new drug application (NDA) for midomafetamine to the FDA in February of this year and received priority review, PDAC provided two “yes” votes and nine “no” votes when questioned whether available data proves that the therapy is effective in patients with PTSD. The committee also provided one “yes” vote and 10 “no” votes when questioned whether the benefits of the therapy outweigh its risk for treating the same group of patients.

PDAC cited numerous factors that contributed to its overarching decision, including a lack of safety data, concerns relating to the placebo effect and Lykos’s protocol which provides therapists with discretion in how they choose to treat their clients.

While the FDA is not obligated to follow PDAC guidance, the news certainly comes as a blow for Lykos Therapeutics.

"We are disappointed in today's vote given the urgent unmet need in PTSD and appreciate that the committee faced a challenging and atypical assignment, which was to evaluate a therapeutic approach that combines drug therapy (MDMA) and psychological intervention," Amy Emerson, chief executive officer of Lykos Therapeutics, said.

Trial data on the effectiveness of MDMA-assisted therapy for PTSD

The data submitted by Lykos to the FDA comes from two randomized, double-blind and placebo-controlled phase 3 trials, MAPP1 and MAPP2, published in 2021 and 2023 respectively. These studies made Lykos Therapeutics the first company to pioneer clinical trials using MDMA – which is currently classified as a Schedule 1 compound in the US – for PTSD treatment. MAPP1 and MAPP2 assessed midomafetamine’s safety and efficacy when used in combination with talking therapy and other means of support provided by a qualified health practitioner, compared to a placebo drug. Both studies met their primary endpoints.

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"Research has suggested the unique properties of MDMA may act as a catalyst to enhance psychotherapy, the current standard of care, by helping diminish the brain's fear and avoidance responses and extend the window of tolerance of painful emotions and memories, thereby allowing people to access and process painful memories without being overwhelmed," said Jerry Rosenbaum, MD, director of the Center for the Neuroscience of Psychedelics at Massachusetts General Hospital Research Institute and Stanley Cobb Professor of Psychiatry at Harvard Medical School.

Identifying new and effective treatments for PTSD

"We remain committed to working with the FDA to address outstanding questions so that we may find a path forward to ensure the responsible and careful introduction of MDMA-assisted therapy into the healthcare system, if approved,” Emerson said.

Should the FDA approve midomafetamine, it would require the Drug Enforcement Administration to reschedule MDMA such that it can be prescribed for medicinal use in the US. Australia’s Therapeutic Goods Administration (TGA) made a similar move in 2023, reclassifying MDMA and psilocybin – the active component of “magic mushrooms” – to a Schedule 8 listing, which allows both drugs to be prescribed with controls.

“We are grateful to the advocates, clinical trial participants and people living with PTSD who shared their testimony in the open public hearing and through written comments, and will continue to do everything we can to bring this potential new therapeutic option to people living with PTSD," Emerson added.

According to the World Health Organization, an estimated 3.9% of the global population has experienced PTSD at some point in their lifetime, and 60% of patients fail to recover within one year.

"PTSD can result in debilitating symptoms that can significantly impact nearly all areas of a person's life and while we have available treatments, unfortunately many people don't respond or stop treatment early, making today's decision an important step forward to identifying new and effective evidenced-based treatment options," Rosenbaum said.

This article is a rework of a press release issued by Lykos Therapeutics. Material has been edited for length and content.