Industry Bulletins | September 30, 2022
B.More Receives FDA Investigational New Drug Approval For Psilocybin Alcohol Addiction Program Phase 2b Clinical Trial
The U.S. Food and Drug Administration (FDA) has approved B.More, Inc.'s investigational new drug (IND) application to begin a Phase 2b clinical trial to determine the efficacy and safety of synthetic psilocybin (SYNP-101) in treating those with alcohol addiction. B.More, Inc. is a non-profit, clinical-stage biopharmaceutical company focused on the development of psychedelic medicines for addiction. Led by principal investigator, Michael Bogenschutz, Director of the New York University (NYU) Langone Center for Psychedelic Medicine, the trial will be initiated in early 2023.
B.More's, randomized, double blind, active placebo-controlled, multicenter, Phase . . .