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 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 Broader Impact

Dr. Elnahal is slated to further discuss the VA's role in research and funding during a panel on Thursday alongside Rep. Jack Bergman (R-Mich.) and former Rep. Tim Ryan (D-Ohio). The panel will explore the future of psychedelic treatments and the role federal institutions could play in advancing this field.

As interest in psychedelics for mental health grows, the VA’s involvement could lead to groundbreaking PTSD therapies. Success hinges on securing funding and clinical evidence to meet regulatory standards.

The Road Ahead

For Lykos Therapeutics, the prospect of VA support is a glimmer of hope. However, significant challenges remain. A new Phase III trial will require substantial funding and without clear answers on how this will be secured, the company’s path forward is uncertain.

In view of this, Lykos met with the FDA earlier this month to discuss what it would take to market its psychedelic treatment for post-traumatic stress disorder. "The meeting resulted in a path forward, including an additional Phase 3 trial, and a potential independent third-party review of prior Phase 3 clinical data," they stated, adding "Lykos will continue to work with the FDA on finalizing a plan and we will continue to provide updates as appropriate." 

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