Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (TEVA), announced encouraging new outcomes in the Phase 3 Subcutaneous Olanzapine Extended-Release Injection Study (SOLARIS) trial, which evaluates TEV-'749 in adult patients diagnosed with schizophrenia.
The trial successfully met its primary endpoint, showcasing substantial improvements in the Positive and Negative Syndrome Scale (PANSS) total score from baseline to week 8. Additionally, significant advancements were observed in key secondary endpoints, including the Clinical Global Impression-Severity (CGI-S) scale and the Personal and Social Performance (PSP) scale score, compared to the placebo at the 8-week mark.
Furthermore, results from the initial SOLARIS phase and Phase 1 safety assessments revealed no instances of post-injection delirium/sedation syndrome (PDSS) among participants administered TEV-'749. The safety profile remained consistent with other oral olanzapine treatments.
Schizophrenia is a multifaceted medical condition necessitating transitions from oral medications to different long-acting injectable (LAI) options throughout patient care. These findings underscore the potential of TEV-'749 as a viable LAI treatment alternative for patients currently on daily oral olanzapine or other antipsychotic medications.
Presently, the only available long-acting olanzapine treatment for schizophrenia is associated with the risk of post-injection delirium/sedation syndrome, characterized by the abrupt onset of delirium or sedation due to rapid medication release into the bloodstream following an intramuscular injection.
