On Wednesday we reported on the impressive results of a new study (Psilocybin Reduces Drinking in 83% of Patients). The work was done by the research team at NYC Langone and it seems the results were impressive enough for the FDA to immediately green light a Phase 2b trial.
“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. “With a reported 83% average reduction in alcohol consumption among heavy drinkers, the results of Dr. Bogenschutz’s recent trial point to the clear potential of psilocybin as a breakthrough in the way we treat AUD.”
Non-profit B.More is sponsoring the upcoming Phase 2b trial, which will build upon this week’s study results.
This quick approval by the FDA shows how the growing amount of study and trial data adds forward momentum to the approval process, and how the FDA seems to be increasingly supportive of psychedelic medicine.
See the full press release below and check out this look at the Clinical Trial Process.
B.More Receives FDA Investigational New Drug Approval for Psilocybin Alcohol Use Disorder Program Phase 2b Clinical Trial
GREENWICH, Conn., Aug. 25, 2022 /PRNewswire/ — B.More Inc., a 501(c)(3) non-profit, clinical-stage biopharmaceutical company focused on the development of psychedelic medicines for substance abuse disorders, today announced that the U.S. Food and Drug Administration has approved its IND application to begin a Phase 2b clinical trial to determine the efficacy and safety of synthetic psilocybin (SYNP-101) in treating patients with alcohol use disorder (AUD). 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. “With a reported 83% average reduction in alcohol consumption among heavy drinkers, the results of Dr. Bogenschutz’s recent trial point to the clear potential of psilocybin as a breakthrough in the way we treat AUD.”
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. The trial plans to enroll a total of 226 participants who will receive psychotherapy and one administration of 30mg of SYNP-101 or the active placebo, niacin. The primary objective of the trial is to determine the efficacy of SYNP-101, compared to niacin, in reducing alcohol consumption during 24-weeks following treatment. Efficacy of treatment will be assessed using changes in alcohol consumption as measured by World Health Organization Risk Drinking Levels Measure of Alcohol Consumption.
About B.More
Founded in 2017 by Carey and Claudia Turnbull, B.More is a 501(c)(3) non-profit, clinical-stage biopharmaceutical company with a mission to develop better treatment options for those struggling with alcohol use disorder and other substance use disorders. Named after Claudia Turnbull’s brother, Brett Moore, who died of a drug overdose 50 years ago, B.More is focused on the development and commercialization of psychedelic medicines that offer the potential to dramatically improve the lives of those for whom current treatment options have not proved effective. Based on a long history of partnership with researchers at the NYU School of Medicine, B.More is advancing clinical research to help these individuals and their loved ones live a better tomorrow.
For more information, please visit www.bmoreinc.org.
