SEP 16, 2022 11:00 AM PDT

A magic cure for alcohol use disorder: FDA approves synthetic psilocybin as an investigational new drug for alcohol use disorder.

WRITTEN BY: J. Bryce Ortiz

Are mushrooms the magic therapeutic to help overcome alcohol use disorder? New data published last month suggest that the answer is yes. Furthermore, the biopharmaceutical company B.More, Inc recently received FDA approval to test their synthetic psilocybin on individuals suffering from alcohol use disorder. 

Alcohol use disorder is a prominent substance abuse problem and affects nearly 15 million Americans, and the problem substantially increased during the COVID-19 pandemic. According to the National Institute of Alcohol Abuse and Alcoholism (NIAAA), less than ten percent of people suffering from alcohol use disorder receive treatment. Now B.More is hoping to change this statistics by providing psychedelic medicines to treat the disorder.

Last month, B.More announced that the United States Food and Drug Administration (FDA) had approved their Investigational New Drug application. This approval will allow B.More to test the effectiveness and safety of their synthetic psilocybin drug, SYNP-101, on patients suffering from alcohol use disorder in a new clinical trial. 

The approval by the FDA came soon after preliminary results from a B.More principal investigator were published in the Journal of the American Medical Association (JAMA) – Psychiatry. In the study, 95 individuals who were diagnosed with alcohol dependence participated in the research. Of the total, 45 participants received the control drug, diphenhydramine, and 48 participants received psilocybin, which were both administered twice, at week 4 and week 8 of the study. All participants also underwent a weekly psychotherapy session during the 12-week study. The participants were then followed for an additional 32 weeks to determine how psilocybin in conjunction with psychotherapy affected alcohol intake. Remarkably, participants in the psilocybin group showed a robust and significant decrease in alcohol consumption compared to the control drug group. Carey Turnbull, CEO of B.More, stated, “With a reported 83% average reduction in alcohol consumption among heavy drinkers, the results of [the study] point to the clear potential of psilocybin as a breakthrough in the way we treat [alcohol use disorder].”

B.More will now add on to these findings in their clinical trial where they plan to enroll a total of 226 participants to test their drug. The company’s main goals for the drug are to reduce heavy drinking days, improve alcohol abstinence, provide long-lasting effects, and offer benefits over existing treatments. Psilocybin is thought to promote neuroplasticity; which refers to the ability of the brain to modify, change, or form new connections between brain structures. As such, psilocybin treatment in conjunction with psychotherapy is thought to help individuals rewire brain connections – shedding off old connections and thought patterns, and giving them a chance to reform connections in healthy ways. Although the exact mechanisms behind how psilocybin improves alcohol use disorder are unclear, B.More believes their drug will improve the lives of those living with addiction. 


Sources: NIAAAMass GeneralB.MoreJAMA - Psychiatry

About the Author
Doctorate (PhD)
Science and medical writer | Researcher | Interested in the intersection between translational science, drug development, and policy
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