The agency has requested an additional Phase 3 trial further assessing for safety and efficacy.
The U.S. Food and Drug Administration (FDA) recently issued a complete response letter (CRL) for Lykos Therapeutics’ midomafetamine (MDMA)-assisted psychotherapy for post-traumatic stress disorder (PTSD), indicating that the therapy cannot be approved based on the current data. The decision comes after a 9 to 2 vote by the Psychopharmacologic Drugs Advisory Committee against recommending the treatment. The agency has requested an additional Phase 3 trial to further assess the therapy’s safety and efficacy, after which it may revisit the matter.
MDMA-assisted psychotherapy involves the controlled administration of midomafetamine, a psychoactive drug, in conjunction with structured therapy sessions. Proponents of this approach cite the effects of the compound on patients, including its ability to promote empathy, reduce fear, and enhance emotional openness, allow patients to more effectively engage with and process traumatic memories in a safe environment. The combination of psychotherapy and MDMA administration can be especially affected for individuals who have experienced severe trauma and have been subsequently diagnosed with PTSD, offering a promising avenue for those who have not responded to traditional treatments.
Lykos’s Chief Executive Officer, Amy Emerson, expressed profound disappointment with the FDA’s decision, particularly in light of the millions of Americans with PTSD who have had limited treatment options for decades. In response to the CRL, Lykos announced plans to request a meeting with the agency to explore alternative pathways for regulatory approval.
Emerson stated, “The FDA request for another study is deeply disappointing, not just for all those who dedicated their lives to this pioneering effort, but principally for the millions of Americans with PTSD, along with their loved ones…By not approving MDMA-assisted therapy, the FDA is risking the lives of the 13 million Americans suffering from PTSD.”
She noted further that many of the regulator’s concerns can very likely be addressed through existing data, post-approval requirements, or references to scientific literature.
Dr. John J. Miller, editor-in-chief of Psychiatric Times, added to Emerson’s sentiments, stating, “The FDA appears to have postponed approval based on a poor understanding of the necessity of the integrated protocol of limited use of MDMA to facilitate well-established psychotherapeutic modalities.” He warned that this decision could set back the approval of similar treatments, including the clinical use of psilocybin, for years, if not decades.
Cristina Pearse, a participant in the Phase 3 trial, also expressed her frustration. Sharing her personal experience with MDMA-assisted therapy, Pearse highlight its transformative impact on her life. “I am living proof that MDMA-assisted therapy is safe, effective, life-changing, and even lifesaving,” she said.
The letter reflects the ongoing debate between safety concerns raised by some activist groups and the urgent calls from veterans and their organizations for new PTSD treatments. In response, Fluence, a psychedelic therapy training organization, acknowledged the importance of safety and scientific rigor, expressing its viewpoint that the CRL is not a setback, but as a natural part of the process.
“The questions raised by the FDA will undoubtedly lead to a more robust understanding of MDMA-assisted therapy, its effects, and its optimal application,” the organization stated.
Veterans Exploring Treatment Solutions (VETS), a non-profit organization dedicated to addressing the veteran suicide crisis, expressed deep concern over the FDA’s decision. However, the organization echoed Fluence’s perspective, stating, “This is not a setback. This is a rally cry,” and urged continued support for veteran healing and the approval of MDMA-assisted therapy.
While disappointment with the FDA’s response is evident, the CRL offers an opportunity for Lyko’s to go back to the drawing board and further enhance its strategy to further prove to the agency that MDMA-assistant treatment is not only safe but remains desperately needed option for treatment-resistant patients. As stakeholders regroup, the focus remains on ensuring this innovative treatment can one day save lives.
Sources:
FDA Issues CRL to Lykos for MDMA-Assisted Therapy
Lykos Therapeutics Announces Complete Response Letter for Midomafetamine Capsules for PTSD
FDA Declines to Approve MDMA Therapy, and Seeks Further Study
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