Changing the treatment paradigm

A new treatment paradigm
Today, there exists no effective and lasting treatment for those struggling with alcoholism. With a 70% relapse rate among those receiving available treatments, a pressing need exists for a safe and effective alternative.
We believe psilocybin-assisted psychotherapy is the answer to alcoholism and other substance use disorders, with current studies demonstrating its efficacy and long-lasting positive effects.
A promising treatment for substance use disorders
Scientific and clinical research has produced promising results in the treatment of alcoholism with psilocybin in combination with psychotherapy.
  • Generally well-tolerated
  • Produces rapid and sustained clinical effects
  • Increases alcohol abstinence and reduction in alcohol consumption and heavy drinking days

Academic study

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An initial pilot study on AUD conducted by Dr. Michael Bogenschutz at the University of New Mexico produced statistically significant results with promising effect sizes.

Phase 2a proof of concept trial

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Published in JAMA Psychiatry in August 2022, a Phase 2a clinical trial led by B. More principal investigator, Dr. Michael Bogenschutz, reported an 83% average reduction in heavy drinking among those receiving psilocybin combined with psychotherapy.   Additionally, the study showed that 8 months after their first dose, almost half (48 percent) of those who received psilocybin stopped drinking altogether compared with 24 percent of the placebo group.

Phase 2b clinical trial

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B.More’s FDA approved, 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 210 participants who will receive psychotherapy and one administration of 30mg of SYNP-101 or an active placebo. The primary objective of the trial is to determine the efficacy of psilocybin in reducing alcohol consumption during 24-weeks following treatment.

Having invested millions of dollars and undertaken over 10 years of research,  B.More is now positioned to commence a pivotal trial designed to secure FDA approval of prescription medicine status for the use of psilocybin to treat alcoholism. Obtaining adequate funding for this trial remains a critical priority for helping the millions of Americans who struggle with alcohol dependence. We welcome your support in making better treatment options a reality.

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