NEW YORK – The FDA declined to approve the MDMA-based therapy for PTSD on August 9. The agency cited insufficient data as the reason for rejection. Developer Lykos Therapeutics announced the decision, expressing disappointment. MDMA PTSD treatment has shown promise in clinical trials, demonstrating notable benefits for patients with severe trauma. #MDMAPTSDTreatment
MDMA, also known as ecstasy or molly, is viewed by advocates as a potential treatment for mental health disorders. They believe it has therapeutic uses beyond its illicit applications.
The FDA decided not to approve the therapy, following a vote by its expert panel. The panel raised concerns about the clinical trial’s conduct during its June meeting. Advisers noted several issues with how Lykos’ application was handled.
The concerns included a “striking lack” of documentation around whether or not the trial participants had abused the drug, problems with how the trial was designed and the need for more evidence.
Lykos said the FDA has asked it to conduct an additional late-stage trial to further study the drug’s safety and efficacy.
The company plans to request a meeting with the FDA to ask for reconsideration of the decision and to discuss the agency’s recommendations for a resubmission seeking approval for the MDMA capsules. #MDMAPTSDTreatment
However, the FDA’s decision reflects concerns about safety and long-term effects. Consequently, this decision delays the potential benefits of MDMA PTSD treatment for many. Advocates argue that continued research is crucial to validate the therapy’s efficacy and safety. Thus, while progress has been made, the journey towards approval continues.
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