Medical company Lykos Therapeutics faced a setback as the US FDA rejected its application to use MDMA as a treatment for PTSD. The FDA cited data limitations and requested an additional Phase 3 trial to study the substance’s safety and efficacy. Lykos expressed disappointment, especially for those suffering from PTSD who may have to wait longer for new treatment options.
Despite the decision, Lykos plans to appeal and has raised concerns about the evaluation process. Observers expected the FDA to refuse the application after a panel of advisors voted against it in June. If approved, MDMA would have been the first illegal psychedelic medicine in the US, following Australia’s lead.
MDMA, also known as the active ingredient in ecstasy, has a history dating back to the early 20th century, with therapeutic and recreational uses. Advocates believe it could complement psychotherapy for various conditions. Lykos, founded in 2014 to bring psychedelic therapies to market, remains committed to its mission amid the setback.
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