FDA Poised To Make Historic Decision On MDMA Therapy To Treat PTSD: Here’s How Things Stand
The U.S. Food and Drug Administration (FDA) is on the verge of making a historic decision regarding the approval of Lykos Therapeutics MDMA-assisted therapy as a mainstream medical treatment for post-traumatic stress disorder (PTSD). The decision, expected by August 11, could mark a turning point in the treatment of this condition for those who have not responded to conventional therapies. As the decision looms, the debate continues. Here is a brief review of how we got to August 11.
Ongoing Debate: Optimism And Controversy Surround MDMA’s FDA Approval
MDMA’s journey to potential FDA approval has been fraught with both optimism and controversy. The substance, the active ingredient found in ecstasy, has long been associated with recreational use, but its potential therapeutic benefits have garnered significant attention in recent years. The substance classification as a Schedule I narcotic poses a barrier to research and treatment. In this context, the FDA granted MDMA breakthrough therapy status in 2017. Several studies were carried out with positive results. Lykos Therapeutics, the company behind the majority of the studies, reported that 71% of participants had their PTSD diagnosis eliminated after undergoing the second stage of the trials.
Concerns And Criticisms: The Integrity Of Clinical Trials In Question
Concerns about the integrity of …