Teva Pharmaceuticals has announced positive Phase 3 SOLARIS trial results for TEV-'749 (olanzapine), an investigational once-monthly subcutaneous long-acting injectable (LAI) formulation for treating schizophrenia. The trial demonstrated significant improvements in social functioning and quality of life in adult patients diagnosed with schizophrenia after eight weeks of treatment.
SOLARIS Trial Results
The Phase 3 SOLARIS trial evaluated the efficacy and safety of TEV-'749 in adult patients with schizophrenia. The results indicated significant improvements in social functioning and quality of life, as measured by validated assessment tools, from baseline to week eight. The safety profile of TEV-'749 was consistent with existing olanzapine formulations, with no new safety signals or Post-Injection Delirium/Sedation Syndrome (PDSS) events reported.
Eric Hughes, Teva's chief medical officer and global R&D executive vice president, 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."
Olanzapine and PDSS Risk
Olanzapine is a second-generation antipsychotic. In vitro data and interim Phase 1 study results suggest that TEV-'749's drug delivery technology and route of administration effectively reduce the risk of PDSS development. These studies showed that the investigational asset maintained controlled-release properties without any spikes in olanzapine concentrations, even upon contact with plasma.
Uzedy (risperidone) Data
Teva also presented real-world data on Uzedy (risperidone), an extended-release injectable for treating schizophrenia in adults, which received FDA approval in April 2023. The data showed high adherence rates and utilization among adults with schizophrenia facing unmet social needs, suggesting its potential to address critical gaps in patient care.
Austedo XR (deutetrabenazine) Findings
In a separate development, interim results from the Phase 4 IMPACT-TD Registry using once-daily Austedo XR (deutetrabenazine) extended-release tablets and twice-daily Austedo (deutetrabenazine) tablets were presented. The findings highlighted differences in treatment patterns for tardive dyskinesia (TD) patients with psychotic disorders compared to those with mood disorders.
