Zinger Key Points The VA’s undersecretary for health announced that the agency is open to funding a new MDMA-PTSD trial with Lykos Therapeutics.
While Lykos’ future is uncertain, VA support for another clinical trial could provide a path forward for both the company and veterans.
The Department of Veterans Affairs (VA) is signaling potential support for another pivotal Phase III clinical trial of psychedelic therapy to treat post-traumatic stress disorder (PTSD). As Politico reported , Dr. Shereef Elnahal , the undersecretary for health at the VA, revealed that the agency is open to aiding Lykos Therapeutics with funding for a new study after the FDA rejected the company’s initial application.
"That is definitely a possibility," Elnahal said during a roundtable with reporters on Tuesday, addressing the agency’s willingness to assist Lykos with the financial burden of a new trial. FDA Rejection And Lykos’ Struggles
This development comes on the heels of a significant setback for Lykos Therapeutics. In August, the FDA rejected the company’s application to use MDMA , commonly known as ecstasy, in combination with talk therapy for PTSD treatment. Despite the initial promise of this approach, FDA advisers concluded that the studies conducted by Lykos failed to demonstrate sufficient evidence of the therapy’s effectiveness or its ability to outweigh potential risks.
The FDA’s decision hit the company hard. Lykos laid off 75% of its staff , and its top leadership departed shortly after . The FDA stated that a new Phase III trial would be required for the application to be reconsidered, a costly and time-consuming hurdle for the struggling company. A Lifeline From The VA?
The VA’s willingness to explore funding partnerships for psychedelic research offers new hope. In January, the VA made headlines by announcing it would fund psychedelic research for the first time since the 1960s, marking a significant shift toward alternative therapies for veterans with high PTSD rates.
While Lykos’ future remains uncertain, the possibility of the VA stepping in to support another clinical trial could offer a critical path forward for both the company and veterans in need of effective PTSD treatments. The […]
Veterans Affairs Eyes Funding For New MDMA-PTSD Trial After FDA Setback
