**Breaking News: FDA Rejects Lykos Therapeutics’ Application for MDMA Treatment of PTSD**
In a disappointing blow to medical innovation, the US FDA has rejected Lykos Therapeutics’ bid to approve the use of MDMA for treating post-traumatic stress disorder (PTSD). The company received a formal response letter indicating that approval could not be granted based on the data submitted.
CEO Amy Emerson expressed deep disappointment at the decision, highlighting the impact on millions suffering from PTSD who may now face prolonged wait times for new treatment options. The FDA cited significant limitations in the application, pushing for additional Phase 3 trials to study the safety and efficacy of the substance.
Lykos plans to appeal the decision and has raised concerns about the evaluation process. The rejection echoes the outcome of a recent Advisory Committee meeting where government advisors voted against the drug’s use.
MDMA, known as the active ingredient in ecstasy, has a controversial history but has shown promise in therapeutic settings. Despite setbacks, Lykos remains committed to bringing innovative psychedelic therapies to market.
Stay tuned for updates on this groundbreaking development in the push for expanded treatment options for mental health disorders.
Source link