The Department of Veterans Affairs (VA) is signaling a potential shift in the landscape of psychedelic therapy for PTSD. Following the FDA's rejection of Lykos Therapeutics' MDMA-PTSD treatment, the VA expressed openness to funding a new Phase III clinical trial. This move highlights the growing recognition of psychedelic therapies as promising treatments, particularly for veterans. The VA's willingness to explore funding partnerships aligns with its recent commitment to alternative therapies. By investing in this emerging field, the VA aims to provide innovative treatment options to veterans struggling with PTSD.
The FDA's decision dealt a significant blow to Lykos, necessitating layoffs and leadership changes. A new Phase III trial poses substantial financial and logistical challenges. However, the VA's potential support offers a glimmer of hope for Lykos. Recent discussions with the FDA have outlined a path forward, including an additional Phase III trial and a potential independent review of existing data. Lykos remains committed to working closely with the FDA to finalize a plan and provide updates.
As Politico reported, Dr. Shereef Elnahal, the undersecretary for health at the VA, revealed during a roundtable with reporters on Tuesday, addressing the agency's willingness to assist Lykos with the financial burden of a new trial. "That is definitely a possibility," he said. If successful, this collaboration could accelerate the development of effective psychedelic therapies and improve the lives of countless veterans.
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