MDMA-assisted therapy for post-traumatic stress disorder (PTSD) has encountered a significant obstacle. Lykos Therapeutics, the company pursuing FDA approval for this treatment, recently announced the FDA’s rejection of their application. The agency cited concerns regarding the treatment’s long-term safety and efficacy and requested further research.
This decision follows a June vote by FDA advisors who also rejected the therapy, raising questions about its effectiveness, safety, the quality of Lykos’s data, and the conduct of therapists involved in earlier studies. While the FDA wasn’t obligated to follow the panel’s recommendation, their conclusion appears to align with the advisors’ concerns.
Lykos CEO Amy Emerson expressed disappointment with the FDA’s decision, arguing that the agency’s requests could be addressed with existing data, post-approval requirements, or existing scientific literature. A third phase 3 trial, as suggested by the FDA, could delay the treatment’s availability for several years.
The FDA has not publicly released the rejection letter, and did not immediately respond to requests for further details. However, an FDA spokesperson told NPR that the application data was insufficient to determine the drug’s safety and efficacy for the proposed PTSD treatment. Despite the setback, the spokesperson affirmed the FDA’s commitment to encouraging research and development of innovative psychedelic and other therapies.
This rejection poses a considerable challenge for Lykos and raises questions about the future of MDMA-assisted therapy for PTSD. While the FDA acknowledges the potential for psychedelic treatments, rigorous research and robust data are crucial for demonstrating both safety and efficacy. The agency’s decision underscores the importance of thorough clinical trials and transparent data analysis in the development of novel treatments for complex mental health conditions. Lykos has indicated their intention to request a meeting with the FDA to discuss the recommendations and explore pathways for resubmission.
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FDA advisers reject MDMA-assisted therapy
