PTSD Hits Roadblock With FDA Rejection

They rejected the notion of using a drug as therapy.

On Friday, proponents of using MDMA (commonly known as Ecstasy or Molly) for treating mental health conditions faced a setback when the U.S. Food and Drug Administration (FDA) denied approval for its use in treating post-traumatic stress disorder (PTSD). The FDA concluded that there was insufficient evidence to support MDMA’s efficacy in alleviating PTSD, directing Lykos Therapeutics, the company advocating for the drug’s approval, to conduct additional clinical trials.

Lykos Therapeutics, which has been working to establish MDMA’s legitimate medical use, expressed disappointment with the FDA’s decision. CEO Amy Emerson criticized the request for another study as disheartening, particularly for those struggling with PTSD who have seen no new treatment options in over 20 years. She argued that many concerns raised by the FDA could potentially be addressed with existing data or through post-approval requirements.

The decision follows a prior advisory board meeting where an FDA committee recommended against MDMA’s approval. This recommendation was unexpected given that Lykos’ trials had been designed with FDA guidance. The trials, which involved 100 PTSD patients, showed promising results: over 60% of participants no longer met the criteria for PTSD after six months of treatment. However, concerns about the drug’s cardiac risks and the influence of concurrent psychotherapy contributed to the FDA’s decision.

Despite the setback, the FDA has not yet released its formal decision letter. An FDA spokesperson acknowledged the need for more treatment options for PTSD and emphasized the agency’s commitment to supporting research in psychedelic therapies. Meanwhile, other companies like Sunstone Therapies are continuing to explore psychedelic treatments, viewing the FDA’s decision as a learning opportunity for refining future trials. The broader conversation about psychedelics in mental health treatment continues, reflecting ongoing debate and interest in alternative therapies.