The US Food and Drug Administration has declined to approve an application for the use of MDMA, commonly known as ecstasy, as a treatment for post-traumatic stress disorder (PTSD). The decision came after drug sponsor Lykos Therapeutics received a request from the agency for an additional Phase 3 trial to further study the safety and efficacy of the treatment.
MDMA, an entactogen that produces experiences of emotional communion and openness, was used in combination with talk therapy in two late-stage clinical trials conducted by Lykos. The trials involved about 200 participants who underwent three eight-hour sessions spaced a month apart, where they took MDMA in the presence of two therapists.
This marks the first time the FDA has considered a psychedelic drug for medical use. However, concerns were raised by an independent FDA advisory committee regarding the integrity of the trials, safety data, and potential bias in efficacy data.
While participants in the trials showed rapid improvement in PTSD symptoms, there were uncertainties about the efficacy and safety of the treatment. Reports indicated significant increases in blood pressure and pulse among participants, with incomplete assessments on related health issues.
Lykos plans to address the FDA's concerns by conducting an additional trial, which could take years. The company remains confident that the issues raised can be resolved and intends to seek a meeting with the agency to discuss recommendations.
Public Citizen, a consumer advocacy group, supported the FDA's decision, emphasizing the importance of rigorous evidence for drug approval. On the other hand, some veterans groups expressed disappointment, stating that the decision may lead to more suffering and lives lost.
PTSD affects about 5% of adults in the US annually, with limited treatment options available. The debate over the use of MDMA for PTSD treatment highlights the need for further research and careful consideration of safety and effectiveness in drug approval processes.
