Teva Pharmaceuticals has announced positive data from the Phase 3 Subcutaneous Olanzapine Extended-Release Injection Study (SOLARIS) evaluating TEV-'749 in adult patients diagnosed with schizophrenia. The study demonstrated significant improvement in social functioning and quality of life across multiple validated measures from baseline to week 8.
SOLARIS Trial Results
The SOLARIS trial is an 8-week, randomized, double-blind, placebo-controlled trial in patients aged 18-64 years diagnosed with schizophrenia. The results showed:
- The mean difference in change in the Personal and Social Performance Scale (PSP), from baseline to week 8, was superior with TEV-'749 318mg (4.63), 425mg (3.15), and 531mg (4.93) versus placebo (all P<0.05).
- Treatment with TEV-'749 significantly improved Schizophrenia Quality of Life Scores (SQLS), with greater mean difference in change from baseline to week 8 observed at the 318mg (-3.99), 425mg (-5.39), and 531mg (-5.65) doses versus placebo (all P<0.05).
Eric Hughes, MD, PhD, Executive Vice President of Global R&D and Chief Medical Officer at Teva, stated, "For people living with schizophrenia receiving treatment, outside of symptom control, potential improvements in social functioning and quality of life are of fundamental importance, so we are delighted to share these encouraging TEV-'749 results."
Safety Profile
The systemic safety profile of TEV-'749 was consistent with other approved oral formulations of olanzapine, with no new safety signals identified and no Post-Injection Delirium/Sedation Syndrome (PDSS) events reported to date. In vitro data and interim results from a Phase 1 study validate that its route of administration and drug delivery technology may effectively address the risk of PDSS development.
UZEDY Real-World Data
Teva also presented results of real-world analyses with UZEDY (risperidone), the Company’s extended-release injectable suspension of risperidone for subcutaneous use every one or two months for the treatment of schizophrenia in adults.
Analyses of U.S. claims data from adults living with schizophrenia who received treatment with UZEDY (n=715) examined social determinants of health (SDOH) as well as patterns of adherence. Results reveal high adherence rates in adults living with schizophrenia who have unmet social needs.
- 69% were adherent (defined as proportion of days covered greater than or equal to 80%).
- A lines of therapy analysis found that use of UZEDY as a first-line treatment option was at 12%. However, patients prescribed UZEDY had most commonly received oral second-generation antipsychotics as their initial therapy.
Christoph Correll, MD, Professor of Psychiatry at the Zucker School of Medicine, Hempstead, NY, commented, "My patients with schizophrenia have a wide range of social backgrounds and experiences, so it’s important that healthcare professionals are able to consider real-world data that incorporate these aspects of life as we consider appropriate treatment options like UZEDY."
About Schizophrenia
Schizophrenia is a chronic, progressive, and severely debilitating mental disorder that affects approximately 1% of the world’s population. Patients experience symptoms including delusions, hallucinations, disorganized speech or behavior, and impaired cognitive ability. The long-term course of schizophrenia is marked by episodes of partial or full remission broken by relapses that often require hospitalization.
