FDA Has Denied the Lykos Therapeutics Application for MDMA-Assisted Therapy

Lucid News The FDA has rejected Lykos Therapeutics’ New Drug Application (NDA) for MDMA-assisted therapy for PTSD. The agency issued a Complete Response Letter to Lykos, stating that the data submitted were insufficient for approval and requested an additional Phase 3 study which could require years of research and significant funding. The FDA’s decision was […]