FDA rejects MDMA

The FDA has rejected Lykos Therapeutics' application to use MDMA as a treatment for PTSD, requesting an additional Phase 3 trial to further evaluate the drug's safety and efficacy. Lykos expressed disappointment, emphasizing the need for new treatment options for the millions suffering from PTSD, especially veterans. The FDA cited 'significant limitations' in the submitted data and concerns raised by an advisory panel, which concluded that the evidence did not support the drug's effectiveness. MDMA remains classified as a Schedule I substance, and the rejection underscores the agency's cautious approach toward psychedelic therapies. Lykos plans to appeal the decision and seek further discussions with the FDA regarding their recommendations. Advocates for MDMA-assisted therapy, including veterans and bipartisan lawmakers, have voiced their support for the treatment, highlighting the urgent need for alternatives in PTSD care.