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Discover the groundbreaking results of Lykos’ application, based on a pair of Phase III clinical trials. One trial showed that 71 percent of PTSD patients who underwent MDMA-assisted psychotherapy were no longer diagnosed with the condition four months after treatment. The FDA briefing document in June acknowledged these findings, stating that participants experienced rapid and lasting improvement in their PTSD symptoms.
However, the document raised concerns about the reliability of the data due to “functional unblinding” issues in the study. Despite these challenges, Lykos remains determined to address the FDA’s queries and move forward with their research.
The FDA’s decision not to approve the drug has sparked controversy, with ethical concerns surrounding the use of MDMA for PTSD treatment. Despite setbacks, Lykos is committed to presenting their robust data to the FDA for reconsideration.
