The U.S. Food and Drug Administration has granted breakthrough designation to an LSD-based treatment for generalized anxiety disorder based on promising topline data from a phase 2b clinical trial.
Mind Medicine (MindMed) Inc. is developing the treatment — MM120 (lysergide d-tartrate).
The company reports that a single oral dose of MM120 met its key secondary endpoint, maintaining "clinically and statistically significant" reductions in Hamilton Anxiety Scale (HAM-A) score, compared with placebo, at 12 weeks with a 65 percent clinical response rate and 48 percent clinical remission rate.
The company previously announced statistically significant improvements on the HAM-A compared with placebo at 4 weeks, which was the trial's primary endpoint.
"I've conducted clinical research studies in psychiatry for over two decades and have seen studies of many drugs under development for the treatment of anxiety. That MM120 exhibited rapid and robust efficacy, solidly sustained for 12 weeks after a single dose, is truly remarkable," study investigator David Feifel, MD, PhD, professor emeritus of psychiatry at the University of California, San Diego, and director of the Kadima Neuropsychiatry Institute in La Jolla, California, said in the news release.
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