The New York Times (5/31, Jacobs , Jewett ) reported the FDA “on Friday raised concerns about the health effects of MDMA as a treatment for post-traumatic stress disorder, citing flaws in a company’s studies that could pose major obstacles to approval of a treatment anticipated to help people struggling with the condition.” FDA staff “said that bias had seeped into the studies because participants and therapists were readily able to figure out who got MDMA versus a placebo.” The agency “also flagged ‘significant increases’ in blood pressure and pulse rates that could ‘trigger cardiovascular events.’”
The AP (5/31, Perrone ) reported the FDA “posted its initial review of the drug Friday, ahead of a meeting of outside advisers who could help decide whether MDMA – currently illegal under federal law – becomes the first drug of its kind to win U.S. approval as a medication.” In the review, “FDA scientists said that patients who received MDMA and talk therapy showed ‘rapid, clinically meaningful, durable improvements in their PTSD symptoms.’” However, “they also called the research ‘challenging to interpret,’ and questioned how long the benefits might last.”
The Washington Post (5/31, Gilbert , Ovalle ) reported, “The agency’s review outlines the challenges for sponsor Lykos Therapeutics, which conducted two late-stage clinical trials showing that patients treated with MDMA – better known by its street name, ecstasy – experienced a significant improvement in their PTSD symptoms relative to those who got a placebo.”
Reuters (5/31, Jain, Roy) reported there “is a large unmet need for new treatments for PTSD, which affects those who have experienced traumatic events and is common among war veterans, as existing drugs do not work on all patients.”
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