Opiant Pharmaceuticals, Inc. announced that the last patient has been enrolled in the Phase 2 clinical trial of OPNT002, nasal naltrexone, for patients with Alcohol Use Disorder (AUD). The total trial duration per patient is 20 weeks, with the last patient enrolled expected to complete the study in early 2023 and with top line data anticipated to follow mid-year. Opiant launched its Phase 2 clinical study of OPNT002 for the treatment of alcohol use disorder in January 2022.

The multi-center, double-blind, randomized, placebo-control Phase 2 study is being conducted in Europe, and is designed to evaluate OPNT002 efficacy, safety, and tolerability in 300 patients with AUD. The trial is being conducted using a Sequential Parallel Comparison Study Design, which is useful in psychiatric studies to reduce the impact of the placebo effect on the assessment of treatment response. The primary end point will be measured by the proportion of patients showing an improvement in World Health Organization (WHO) Risk Levels of Alcohol Consumption consisting of a 2-level reduction from baseline to end of treatment.