Teva Pharmaceuticals presented positive Phase 3 SOLARIS trial data for TEV-‘749, a subcutaneous olanzapine extended-release injection, at Psych Congress 2024 in Boston. The study evaluated TEV-‘749 in adult patients diagnosed with schizophrenia, demonstrating significant improvements in social functioning and quality of life.
SOLARIS Trial Results
In the acute treatment phase (Period 1) of the SOLARIS trial, TEV-‘749 showed statistically significant improvements from baseline to week 8 across multiple validated measures of social functioning and quality of life. These findings suggest a clinically meaningful benefit for patients suffering from schizophrenia.
Safety Profile
The systemic safety profile of TEV-‘749 was consistent with that of approved oral olanzapine formulations. Notably, the trial did not identify any new safety signals, and no Post-Injection Delirium/Sedation Syndrome (PDSS) events were reported to date. This is a critical factor, as PDSS is a known risk associated with injectable antipsychotics.
Addressing PDSS Risk
In vitro data and interim results from a Phase 1 study evaluating the pharmacokinetic characteristics of TEV-‘749 indicate that its route of administration and drug delivery technology may effectively address the risk of PDSS development. This is a significant advantage, potentially improving patient safety and adherence to treatment.
