Today, the Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Lykos Therapeutics in response to their application for approval of MDMA-assisted therapy. While this is not the victory for psychedelic-assisted therapy we hoped for, we know that no battle is won without facing adversity. This development is merely another hurdle in our ongoing mission to end the veteran suicide epidemic.
Roughly 20 veterans die by suicide every day. A recent study estimates the number could be as high as 44. This is unacceptable. The potential of MDMA-assisted therapy to help veterans heal from post-traumatic stress disorder (PTSD) remains paramount. We will not allow bureaucratic processes to deter us from advocating for approval of this transformative treatment.
While we understand and respect the FDA’s commitment to safety, we urge careful consideration of the cost of inaction. As we await the next steps from regulatory bodies, VETS remains committed to:
- Providing access to psychedelic-assisted therapies abroad.
- Conducting groundbreaking research to build an irrefutable case for these treatments.
- Fighting tirelessly to make these innovative therapies clinically available on U.S. soil.
The fight for safe, legal access to MDMA-assisted therapy may have hit a roadblock, but VETS stands resolute. We wholeheartedly believe that every veteran deserves access to the most effective forms of healthcare available.
We are never out of the fight. Join us in our mission to END veteran suicide.