Teva Pharmaceuticals announced positive data from the Phase 3 SOLARIS trial of TEV-'749, a subcutaneous olanzapine extended-release injection, demonstrating significant improvements in social functioning and quality of life for adults with schizophrenia. The findings, presented at Psych Congress 2024, highlight the potential of TEV-'749 as a long-acting injectable (LAI) treatment option. Additionally, real-world analyses of UZEDY (risperidone) revealed high adherence rates among patients with schizophrenia facing social barriers to treatment.
The SOLARIS trial, an 8-week, randomized, double-blind, placebo-controlled study, involved patients aged 18-64 years diagnosed with schizophrenia. Results indicated that TEV-'749 significantly improved social functioning and quality of life by week 8 compared to placebo. Specifically, the mean difference in change in the Personal and Social Performance Scale (PSP), a standard measure of social functioning, from baseline to week 8 was superior with TEV-'749 at doses of 318mg (4.63), 425mg (3.15), and 531mg (4.93) versus placebo (all P<0.05).
Improvements in Quality of Life
Treatment with TEV-'749 also led to significant improvements in Schizophrenia Quality of Life Scores (SQLS), with greater mean differences 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). Changes from baseline to week 8 in EuroQoL-5 Dimensions-3 Levels, another quality-of-life measure, were numerically higher at week 8 with TEV-'749 at the 425mg dose versus placebo.
Safety Profile and PDSS Risk
Notably, 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 suggest that the drug delivery technology of TEV-'749 may effectively address the risk of PDSS development.
Real-World Evidence with UZEDY
Teva also presented real-world analyses of UZEDY (risperidone), an extended-release injectable suspension for subcutaneous use in adults with schizophrenia. These analyses of U.S. claims data (n=715) revealed high adherence rates (69%) among patients with unmet social needs, such as low educational attainment, poverty, food insecurity, limited access to healthcare, and housing instability (44%).
Implications for Schizophrenia Treatment
"For people living with schizophrenia receiving treatment, outside of symptom control, potential improvements in social functioning and quality of life are of fundamental importance," said Eric Hughes, MD, PhD, Executive Vice President of Global R&D and Chief Medical Officer at Teva. He added that the real-world studies evaluating UZEDY will help healthcare professionals understand the impact of unmet social needs on people living with schizophrenia and their treatment.
Christoph Correll, MD, Professor of Psychiatry at the Zucker School of Medicine, commented on TEV-'749, stating, "we may soon be able to offer schizophrenia treatment for patients taking daily oral olanzapine with a long-acting injectable option that may reduce the risk of this potentially life-threatening side effect. This is an important advancement for those who may benefit from a long-acting treatment approach."
These findings underscore Teva's commitment to addressing the complex needs of individuals with schizophrenia through innovative treatment options and a focus on patient-centered outcomes. TEV-'749 is currently investigational and not approved by any regulatory authority.
