Recently, a U.S. Food and Drug Administration (FDA) panel made a decision on MDMA-based treatments for post-traumatic stress disorder (PTSD), a treatment often used in veteran care. The advisory committee voted 10-1 against the overall benefits of using MDMA to treat PTSD. During the nine-hour hearing held in Maryland, the panel raised concerns about study flaws, unclear data, and potentially harmful side effects, leading to a 9-2 vote against the drug’s efficacy.
The application for psychedelic-assisted therapies was submitted by Lykos Therapeutics in California. The company expressed disappointment in the FDA’s decision and emphasized the urgent unmet need for effective PTSD treatments. Despite the setback, they remain committed to working with the FDA to address outstanding questions and ensure the responsible introduction of MDMA-assisted therapy if approved.
Juliana Mercer, a Marine Corps veteran and advocate for psychedelic-assisted therapies, expressed her disappointment with the decision. She highlighted the testimonies of veterans who have benefited from the therapy and stressed the importance of finding effective solutions for PTSD. Mercer mentioned that the advisory committee’s focus shifted from data and facts to concerns about drug abuse, integrity, and motivation, leading to the rejection of the treatment.
While the decision is disheartening, there is hope that it may be overruled, considering the significant need for innovative PTSD treatments. The Department of Veteran Affairs (VA) is currently conducting 13 MDMA-based trials, indicating ongoing research and interest in exploring alternative therapies for veterans. The FDA plans to continue working with Lykos Therapeutics to address concerns before the final decision deadline on August 9.
In addition to MDMA, the VA will also study psilocybin-assisted therapies. While the FDA’s decision is crucial, the VA remains committed to promoting research that benefits veterans’ health. VA Press Secretary Terrence Hayes emphasized the agency’s dedication to conducting high-quality research and exploring new therapies to address mental health conditions like PTSD.
Experts in the field, such as Dr. Rachel Yehuda and Dr. Charles Marmar, recognize the therapeutic potential of psychedelics when carefully studied under strict medical guidance. While there are concerns about recreational use, both doctors see value in exploring these treatments under controlled conditions.
Overall, the rejection of MDMA-based treatments for PTSD is a setback in the quest to find effective solutions for veterans and individuals struggling with mental health challenges. However, ongoing research, advocacy efforts, and collaboration between organizations like Lykos Therapeutics, the FDA, and the VA offer hope for future breakthroughs in treating PTSD and improving the lives of those affected by the condition.