FDA Staff Raises Concerns About Ecstasy Drug's Safety in Report.

The US Food and Drug Administration (FDA) has expressed concerns about the safety of an experimental MDMA drug developed by Lykos Therapeutics Inc. for the treatment of post-traumatic stress disorder (PTSD). The FDA staff report states that the drug may increase the risk of heart attacks and strokes and highlights the vulnerability of patients under the influence of the drug. The FDA will review the data at a meeting on June 4, with a final decision expected by August. If approved, the drug would be restricted to certified healthcare clinics and patients would be required to enroll in a safety registry. The efficacy of MDMA is also questioned, as patients in studies were able to guess whether they received the treatment or placebo based on psychedelic effects, leading to potential "expectation bias." PTSD affects about 6% of people in the US, with higher rates among women and veterans. The Multidisciplinary Association for Psychedelic Studies (MAPS), the nonprofit behind Lykos, has been investigating psychedelic therapies for over three decades and has faced allegations of minimizing negative reports about the drug. An independent scientific group also raised questions about the research behind MDMA in PTSD, stating that Lykos had not proven the treatment's benefits. [Extracted from the article]

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