Key clinical points: Olanzapine (OLZ)/samidorphan (SAM) combination therapy demonstrates sustained improvement in schizophrenia symptoms and is generally well-tolerated over 52 weeks.

Major finding: In all, 66.1% of patients completed the 52-week treatment period. Positive and Negative Syndrome Scale (PANSS) total and Clinical Global Impression-Severity (CGI-S) scores improved from baseline to 52 weeks (mean changes: PANSS, −16.2 [95% confidence interval (CI), −18.5 to −14.0] and CGI-S, −0.9 [95% CI, −1.0 to −0.8]) with the majority of patients achieving stabilization (88.7%) and not relapsing (89.5%). Overall, 136 (49.1%) patients reported adverse events (AEs); increased weight and somnolence were most common. A total of 8 patients (2.9%) reported serious AEs with no deaths.

Study details: The data come from a 1-year open-label extension study of 281 patients with schizophrenia who completed the 4-week treatment period of ENLIGHTEN-1.

Disclosures: This study was sponsored by Alkermes, Inc. Sergey Yagoda, Christine Graham, Adam Simmons, Christina Arevalo, and Ying Jiang are employees of Alkermes, Inc. David McDonnell is an employee of Alkermes Pharma Ltd.