Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that oh-so familiar routine of phone calls, online meetings, and deadlines has predictably returned. But you knew this would happen, yes? After all, we can only move forward. So what better way to cope than with a refreshing cup or two of stimulation? Our choice today is a summer favorite — blueberry cobbler. Please feel free to join us. Meanwhile, we have assembled a few items of interest below for your perusal. We hope you find them useful. On that note, time to get cracking. Have a smashing day, and please do keep in touch. …
The U.S. Food and Drug Administration rejected MDMA as a treatment for post-traumatic stress disorder on Friday, in a blow to drug activists and veterans who have long campaigned for the psychedelic treatment, STAT reports. Although two Phase 3 trials suggested the treatment was effective, strong opposition by an agency scientific advisory committee in June and allegations of missing adverse event data and research bias may have doomed the application from Lykos Therapeutics. The FDA requested Lykos conduct another Phase 3 trial to further study safety and efficacy, and Lykos said it will request a meeting with the FDA to ask for reconsideration of the decision.
Meanwhile, the journal Psychopharmacology has retracted three papers about MDMA-assisted psychotherapy — right on the heels of the FDA rejection of the closely watched treatment for PTSD, STAT tells us. Many authors on the three studies are affiliated with the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS) and its commercial spinout Lykos Therapeutics, including founder Rick Doblin, who spearheaded the decades-long efforts to win approval for the psychedelic treatment. Lykos CEO Amy Emerson is an author as well.
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