5-MeO-DMT Nasal Spray Shows Promise in Phase 2a Alcohol Use Disorder Trial

Key Insights

• A single dose of BPL-003, a synthetic intranasal 5-MeO-DMT formulation, combined with behavioral therapy, significantly reduced alcohol consumption from 9.3 to 2.2 units per day over 12 weeks.
• The Phase 2a trial demonstrated impressive outcomes with 50% of participants maintaining complete abstinence throughout the study period and mean abstinent days increasing from 33% to 81%.
• The treatment showed favorable safety profile with only mild to moderate adverse events and efficient clinical administration, allowing patient discharge within approximately two hours.

Atai Life Sciences has reported promising topline results from a Phase 2a study of BPL-003, showing significant potential in treating moderate to severe alcohol use disorder (AUD). The novel treatment, developed by Beckley Psytech, combines a patent-protected synthetic intranasal formulation of 5-MeO-DMT benzoate with relapse prevention cognitive behavioral therapy.

Significant Reduction in Alcohol Consumption

The open-label study, which enrolled 12 patients with moderate to severe AUD, demonstrated remarkable improvements in drinking patterns following a single dose of BPL-003. Participants showed a substantial decrease in daily alcohol consumption, with average intake dropping from 9.3 units to 2.2 units by the end of the 12-week study period.

Heavy drinking days (HDDs) - defined as consuming seven or more units for women and nine or more units for men - saw a dramatic reduction from 56% to 13% at Week 12. Perhaps most notably, the mean number of abstinent days increased significantly from 33% to 81%, with half of the study participants maintaining complete abstinence throughout the entire study duration.

Safety Profile and Treatment Administration

BPL-003 demonstrated a favorable safety profile during the trial. Adverse events were consistently reported as mild or moderate, with no serious or severe incidents recorded. The treatment's practical administration protocol proved efficient, with most patients ready for discharge within approximately two hours of treatment.

Treatment Design and Future Prospects

The innovative approach combines rapid-acting pharmacology with established therapeutic support, designed to deliver durable treatment effects from a single dose while maintaining a short in-clinic treatment time. This could represent a significant advancement in addressing the challenges of AUD treatment adherence and efficacy.

Beckley Psytech has indicated plans to explore further development options for BPL-003 in substance use disorders. The company anticipates sharing additional clinical data from this study through publications and conference presentations in 2025.

The results of this early-phase trial suggest potential for a paradigm shift in AUD treatment, offering a novel approach that could address the significant unmet needs in current alcohol use disorder management strategies.