TEVA(US:TEVA) Globenewswire·2025-12-09 13:00Core Viewpoint - Teva Pharmaceuticals has submitted a New Drug Application (NDA) to the FDA for olanzapine extended-release injectable suspension (TEV-'749) aimed at treating schizophrenia in adults, based on positive results from the Phase 3 SOLARIS trial [1][2]. Company Overview - Teva Pharmaceutical Industries Ltd. is transitioning into a leading innovative biopharmaceutical company, focusing on neuroscience and immunology, while maintaining a strong generics business [6][7]. - The company is dedicated to addressing patients' needs through innovative treatments and has a commitment to advancing its long-acting injectable (LAI) franchise [6][7]. Product Details - Olanzapine LAI is a once-monthly subcutaneous formulation of the second-generation antipsychotic olanzapine, designed to improve adherence and stability for patients with schizophrenia [2][6]. - The product utilizes SteadyTeq™, a proprietary copolymer technology from Medincell, which allows for a controlled and sustained release of olanzapine [3]. Clinical Study Information - The SOLARIS trial is a multinational, multicenter, randomized, double-blind, placebo-controlled study involving 675 patients aged 18-64, evaluating the efficacy, safety, and tolerability of olanzapine LAI [4]. - The primary objective of the SOLARIS study was to assess the efficacy of olanzapine LAI, with secondary objectives focusing on additional efficacy parameters and safety evaluations [4]. Industry Context - Schizophrenia is a chronic and debilitating mental disorder affecting approximately 1% of the global population, with around 3.5 million diagnosed individuals in the U.S. [5]. - The disorder often leads to high rates of relapse, with about 80% of patients experiencing multiple relapses within the first five years of treatment, contributing to significant healthcare costs [5].