FDA Rejects Application to Treat PTSD with Ecstasy
2024-08-10 12:04:42
The United States Food and Drug Administration (FDA) rejected an application to treat post-traumatic stress disorder (PTSD) with MDMA (methylenedioxymetaamphetamine), also known as ecstasy, citing the need for further research.
The company that submitted the application, Lykos Therapeutics, stated that the FDA requested an additional Phase 3 clinical trial to assess the “safety and efficacy” of MDMA.
Last March, a panel of experts convened by the FDA to evaluate clinical data on MDMA voted overwhelmingly to conclude that there is insufficient evidence to demonstrate its effectiveness for PTSD treatment. This decision represents a setback for advocates of this proposed treatment.
“The FDA’s request for another study is deeply saddening, not only for all those who dedicated their lives to this pioneering effort, but especially for the millions of Americans with PTSD who have never been diagnosed,” said Amy Emerson, CEO of Lykos.
PTSD is a debilitating mental illness triggered by traumatic events such as death, war, or sexual assault. Current pharmacological treatment options for PTSD are limited and often require three months of dosing to take effect, with inconsistent results.
MDMA is classified as a Schedule 1 drug under the Controlled Substances Act, making its potential medical use highly significant. Lykos based its application on two clinical trials, which suggested that MDMA is safe and effective in treating PTSD. However, a majority of the FDA panel experts concluded that the available data was insufficient to support these claims.
The FDA raised concerns about the methodology of Lykos’ clinical trials and criticized the company for inadequate data collection on side effects. Lykos responded by pledging to address these concerns and work towards a resolution.