Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries, has announced additional positive results from the Phase 3 SOLARIS trial of TEV-‘749 (olanzapine) in the treatment of schizophrenia.
TEV-‘749 is an investigational once-monthly subcutaneous long-acting injectable (LAI) formulation of the second-generation antipsychotic olanzapine.
The Phase 3 SOLARIS trial showed significant improvements in social functioning and quality of life after eight weeks in adult patients diagnosed with schizophrenia.
TEV-‘749’s safety profile aligns with existing olanzapine formulations, with no new safety signals or Post-Injection Delirium/Sedation Syndrome (PDSS) events reported.
During the acute treatment phase of the study, TEV-‘749 demonstrated significant improvement in social functioning and quality of life across multiple validated measures from baseline to week eight.
Olanzapine has a safety profile similar to approved oral olanzapine formulations.
Additionally, in vitro data and interim Phase 1 study results confirm that olanzapine’s drug delivery technology and route of administration effectively reduce the risk of PDSS development.
Israel-based Teva Pharmaceutical said that these new results highlight the potential benefits of TEV-‘749 for patients.
In September, the company announced positive efficacy, safety and tolerability results and in May, it reported promising results from the efficacy portion of the SOLARIS trial.
In addition to the SOLARIS study, Teva presented in vitro results comparing the antipsychotic olanzapine to the currently marketed intramuscular olanzapine long-acting injectable regarding the risk of PDSS.
Phase 1 data on the pharmacokinetics of TEV-‘749 were also shared. The studies showed that the investigational asset maintained controlled-release properties without any spikes in olanzapine concentrations, even upon contact with plasma.
Teva chief medical officer and global R&D executive vice president Eric Hughes said: “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.”
Additionally, Teva presented real-world data on Uzedy (risperidone), an extended-release injectable for treating schizophrenia in adults. Uzedy received approval from the US Food and Drug Administration (FDA) in April 2023.
Results showed high adherence rates and utilisation among adults with schizophrenia facing unmet social needs.
In a separate development, the Israeli firm announced interim results from the Phase 4 IMPACT-TD Registry using once-daily Austedo XR (deutetrabenazine) extended-release tablets and twice-daily Austedo (deutetrabenazine) tablets.
The findings highlighted differences in treatment patterns for TD patients with psychotic disorders compared to those with mood disorders.
