B.More Receives FDA Investigational New Drug Approval for Psilocybin Alcohol Use Disorder Program Phase 2b Clinical Trial
Led by principal investigator, Michael Bogenschutz, Director of the NYU Langone Center for Psychedelic Medicine, the trial will be initiated in early 2023.
- Led by principal investigator, Michael Bogenschutz, Director of the NYU Langone Center for Psychedelic Medicine, the trial will be initiated in early 2023.
- "Given the amazing results of the psilocybin for AUD Phase 2a trial that our principal investigator, Dr. Bogenschutz, just published in JAMA Psychiatry , we are thrilled to have received FDA approval to begin our Phase 2b trial", said Carey Turnbull, co-founder and CEO of B.More.
- B.More's, randomized, double blind, active placebo-controlled, multicenter, Phase 2b trial will assess the efficacy and safety of synthetic psilocybin (SYNP-101) in treating moderate to severe AUD.
- Efficacy of treatment will be assessed using changes in alcohol consumption as measured by World Health Organization Risk Drinking Levels Measure of Alcohol Consumption.