A Major Setback for the Psychedelics Industry: 

FDA Denies Lykos Therapeutics’ MDMA Therapy Approval



The psychedelics industry has recently faced a significant setback as the U.S. Food and Drug Administration (FDA) denied Lykos Therapeutics’ approval request for MDMA-assisted therapy for PTSD. This decision has cast a shadow on the burgeoning field of psychedelic-assisted therapies, which has been gaining momentum over the past few years.

FDA Denial and Its Implications

Lykos Therapeutics, previously known as MAPS Public Benefit Corporation (MAPS PBC), has been at the forefront of developing MDMA-assisted therapy for PTSD. The company’s New Drug Application (NDA) for midomafetamine capsules was backed by promising results from multiple clinical trials, including the pivotal Phase 3 MAPP1 and MAPP2 studies. These studies demonstrated significant improvements in PTSD symptoms among participants who received the MDMA-assisted therapy compared to those who received a placebo.

However, during the recent meeting of the FDA’s Psychopharmacologic Drugs Advisory Committee, critics expressed serious concerns about the trial data’s reliability and the therapy’s safety profile. Despite the promising trial results, these concerns ultimately led to the FDA’s decision to deny the approval request, marking a major blow to the psychedelics industry’s efforts to gain regulatory acceptance and mainstream credibility.

A Long Road for Psychedelic Research

This denial is particularly disheartening given the decades of research and advocacy by the Multidisciplinary Association for Psychedelic Studies (MAPS). Founded over 40 years ago, MAPS has been a pioneer in psychedelic research, working tirelessly to develop medical, legal, and cultural contexts for the beneficial use of psychedelics. MAPS incubated Lykos Therapeutics with the goal of bringing MDMA-assisted therapy to market as a viable treatment for PTSD.

The recent FDA decision underscores the challenges that the psychedelics industry faces in gaining regulatory approval. Despite extensive research and significant financial investment, the path to acceptance for psychedelic therapies remains fraught with obstacles. This setback highlights the need for continued rigorous research and transparent dialogue with regulatory bodies to address safety and efficacy concerns.

Moving Forward

While the FDA’s decision is a significant setback, it is not the end of the road for Lykos Therapeutics or the broader psychedelics industry. Both MAPS and Lykos remain committed to their mission of advancing psychedelic research and improving mental health treatment options. They will likely need to address the concerns raised by the FDA and continue their research efforts to demonstrate the safety and efficacy of MDMA-assisted therapy.

For more detailed information on the FDA’s decision and its implications, you can read the full article on the Green Market Report here. Additionally, to learn more about the ongoing work of MAPS and Lykos Therapeutics, visit their websites at MAPS and Lykos Therapeutics.

The road ahead may be challenging, but the commitment and dedication of these organizations provide hope for the future of psychedelic-assisted therapies.


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