Veterans Affairs Eyes Funding For New MDMA-PTSD Trial After FDA Setback
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 …