Psychedelic Therapies Gain Momentum in Pharmaceutical Industry

Atai Reports Positive Results for DMT-Based Therapy in Alcohol Use Disorder

Atai Life Sciences has announced encouraging results from a Phase IIa study of BPL-003, an intranasal formulation of 5-MeO-DMT benzoate, for the treatment of alcohol use disorder (AUD). The study, which combined BPL-003 with relapse prevention cognitive behavioral therapy, demonstrated significantly reduced alcohol consumption among participants over a 12-week period.

The trial, involving 12 patients with moderate to severe AUD, showed a marked decrease in daily alcohol consumption, with the mean number of units consumed dropping from 9.3 to 2.2 by the study's conclusion. Notably, 50% of patients maintained complete abstinence for at least three months. The treatment was well-tolerated, with no serious adverse events reported, and patients were able to be discharged within two hours of administration.

Srinivas Rao, CEO and co-founder of Atai, expressed optimism about the results and anticipates Phase IIb data for BPL-003 in treatment-resistant depression (TRD) by mid-2025. H.C. Wainwright analysts described the data as "encouraging," suggesting that BPL-003 may have potential for durable effects in AUD and supporting its advancement in this indication.

FDA Approval of Esketamine Monotherapy Bolsters Psychedelic Space

The positive results from Atai's study come on the heels of a significant development in the psychedelic therapy landscape. The U.S. Food and Drug Administration (FDA) recently approved Johnson & Johnson's esketamine nasal spray, Spravato, as the first and only monotherapy for adults with TRD.

While not considered a classic psychedelic, Spravato's approval and commercial performance have been viewed as supportive of the broader psychedelic therapy field. Jefferies analysts noted that Spravato's consistent quarter-over-quarter trajectory "supports the notion psychedelics can become commercially viable for mental health." In the fourth quarter of the previous year, worldwide sales of Spravato grew by 5% to $297 million compared to the same period in 2023.

Industry Outlook and Future Developments

The recent successes in psychedelic therapies have reinvigorated a sector that faced setbacks in 2024, notably with the FDA's rejection of Lykos Therapeutics' MDMA-assisted therapy for post-traumatic stress disorder in August of that year. Industry observers are now closely watching for upcoming results from other psychedelic treatments, including Compass Pathways' COMP360, a psilocybin-based therapy for depression, with Phase III readouts expected in Q2 of this year and the second half of 2026.

As the pharmaceutical industry continues to explore the potential of psychedelic-based therapies, these recent developments suggest a growing acceptance and potential for these treatments in addressing various mental health conditions and substance use disorders. The field remains dynamic, with ongoing clinical trials and regulatory decisions shaping the future of psychedelic medicine.