FDA considers MDMA treatment

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The U.S. Food and Drug Administration (FDA) is currently reviewing a New Drug Application (NDA) for MDMA-assisted therapy for the treatment of post-traumatic stress disorder (PTSD). This review follows the submission of the NDA by MAPS Public Benefit Corporation, now known as Lykos Therapeutics. The application includes data from two pivotal Phase 3 trials, MAPP1 and MAPP2, which demonstrated the efficacy and safety of MDMA-assisted therapy in reducing symptoms of PTSD compared to placebo.

FDA Review Process and Timeline

The FDA has granted the application a priority review status, which is reserved for drugs that could significantly improve the treatment, diagnosis, or prevention of serious conditions. This status accelerates the review process, setting a Prescription Drug User Fee Act (PDUFA) target action date of August 11, 2024. Priority review can shorten the FDA's decision-making process from the standard 10 months to 6 months.

Clinical Trial Findings

The clinical trials, MAPP1 and MAPP2, involved multiple sessions of MDMA-assisted therapy and were randomized, double-blind, and placebo-controlled. The primary endpoint was the change from baseline in the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) scores. Results showed a significant reduction in PTSD symptoms among participants who received MDMA-assisted therapy compared to those who received a placebo. Notably, a substantial percentage of participants in the MDMA group no longer met the diagnostic criteria for PTSD at the end of the study.

Safety and Efficacy

The trials reported that MDMA-assisted therapy was well-tolerated, with no serious adverse events. The most common side effects were mild to moderate in severity, such as muscle tightness, nausea, decreased appetite, and sweating. These findings suggest that MDMA-assisted therapy could be a safe and effective treatment option for PTSD, addressing a significant unmet need in mental health care.

Regulatory and Future Considerations

If the FDA approves the NDA, this would mark the first instance of a psychedelic-assisted therapy being authorized for medical use in the United States. Approval would also necessitate a reclassification of MDMA by the Drug Enforcement Administration (DEA), as it is currently classified as a Schedule I drug, indicating a high potential for abuse and no accepted medical use. The potential approval of MDMA-assisted therapy is seen as a significant advancement in the treatment of PTSD, offering hope to millions affected by this condition annually. It also represents a broader shift in the perception and regulatory approach to psychedelic substances in medical treatment.
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