Teva Announces Positive Post Hoc Data for Olanzapine LAI in Schizophrenia Treatment

Parsippany, N.J., Sept. 18, 2026 (GLOBE NEWSWIRE), Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., announced new post hoc data from the pivotal SOLARIS Phase 3 trial, highlighting the efficacy and safety of TEV-'749, a once-monthly subcutaneous long-acting injectable (LAI) formulation of olanzapine for the treatment of schizophrenia in adults. The findings were presented at Psych Congress, held September 15-19, 2026, in New Orleans, LA.

The post hoc analysis of the open-label safety stage of the SOLARIS trial showed that more than half of the participants receiving TEV-'749 achieved stabilization, with few experiencing relapse. Specifically, among 411 participants, 231 (56%) achieved stabilization, and among those who achieved stabilization, only 10 (4%) experienced relapse. The data also revealed that 39 (21%) of 183 participants treated with TEV-'749 for six or more months met criteria for remission, defined as maintaining a Positive and Negative Syndrome Scale (PANSS) item score of 3 or lower for at least six consecutive months across eight specific remission items.

The SOLARIS study, a multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled trial, involved 675 patients. For the first 8 weeks, patients were randomized to receive a subcutaneous injection of once-monthly olanzapine LAI (low, medium, or high dose) or placebo in a 1:1:1:1 ratio. For the next 48 weeks, patients who completed the initial period on placebo were re-randomized and equally allocated to one of the three olanzapine LAI treatment groups, while those who completed the initial period on active olanzapine LAI remained on their established dose strength.

Schizophrenia is a chronic, severely debilitating mental disorder that affects approximately 1% of the world's population, with 2.2 million people in the U.S. currently diagnosed with the condition. Symptoms include delusions, hallucinations, disorganized speech or behavior, and impaired cognitive ability. The average age of onset tends to be in the late teens to the early 20s for men, and the late 20s to early 30s for women. The long-term course of schizophrenia is marked by episodes of partial or full remission broken by relapses that often occur in the context of psychiatric emergency and require hospitalization. Approximately 80% of patients experience multiple relapses over the first five years of treatment, and each relapse carries a biological risk of loss of function, treatment refractoriness, and changes in brain morphology.

Teva's commitment to patient-centered innovation in neuroscience is underscored by the growing body of science around TEV-'749. The company's long-acting injectable franchise, including TEV-'749, aims to support long-term symptom control and reduce the risk of relapse for individuals living with schizophrenia. Ahead of the Q4 FDA anticipated approval decision, the findings from the SOLARIS trial and the treatment switch analyses provide valuable clinical insights into maintaining established therapeutic ranges of olanzapine when initiating TEV-'749 from existing regimens.