Developers in the psychedelic field remain hopeful despite the FDA’s Complete Response Letter (CRL) issued on August 9 for Lykos Therapeutics’ MDMA-assisted treatment for PTSD. Experts anticipate that Lykos will ultimately receive approval.
The FDA’s decision to not approve Lykos’ New Treatment Application (NTA) is viewed by many as a temporary setback rather than a permanent obstacle. Doug Drysdale, CEO of Cybin, commented, “I think this program is fixable and will likely lead to an approval at some point.”
The broader field sees the rejection as a signal of caution rather than opposition to psychedelic therapies. The FDA’s decision, while disappointing, does not negatively impact other similar programs, according to Drysdale. He emphasized that the rejection stemmed from issues with the NTA submission rather than concerns about safety or effectiveness.
Rob Barrow, CEO of MindMed, shared a similar perspective, emphasizing the need for high-quality studies and rigorous ethics to support future approvals. He noted that the CRL reinforces the importance of thorough and ethical research practices.
The FDA’s CRL cited incomplete data in Lykos’ NTA, including missing safety information and post-baseline assessments. The FDA has requested an additional Phase III study to address these gaps. Fran Brown from Certara agreed with the FDA’s decision, highlighting that the safety risks were not fully described.
Lykos plans to request reconsideration of the decision and seek guidance for resubmission. Fluence, a continuing education organization in the field, views the CRL as progress, providing a roadmap for future approvals.
The feedback from the FDA will benefit other organizations in the field. Drysdale noted that Cybin has incorporated lessons from the CRL into its own program design, including strategies to address unblinding issues. MindMed also focuses on managing patient expectations in its trials.
Barrow and Drysdale believe that while the CRL is a setback, it ultimately benefits the sector by encouraging more robust studies and treatments. The FDA has acknowledged the need for innovative mental health solutions and continues to support research in this area.