Ontology highlight
ABSTRACT: Background
Optimal pharmacological efficacy is crucial in first-episode and early-episode schizophrenia and bipolar I disorder. Olanzapine (OLZ) is a highly efficacious antipsychotic indicated for the treatment of schizophrenia and bipolar I disorder. However, the clinical utility of OLZ may be limited by a propensity to cause significant weight gain and increased metabolic side effects, especially for patients early in the course of their illness. ALKS 3831 is composed of a flexible dose of olanzapine (OLZ) and a fixed dose of 10 mg of samidorphan (SAM), formulated as a bilayer tablet. ALKS 3831 has been shown in Phase 1 and Phase 2 studies to result in significantly less weight gain than OLZ while delivering equivalent antipsychotic efficacy. This Phase 3, 12-week study
SUBMITTER: Simmons A
PROVIDER: S-EPMC5888899 | biostudies-literature | 2018 Apr
REPOSITORIES: biostudies-literature