Teva presents new Phase 3 efficacy, safety data from SOLARIS trial

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries, announced new efficacy, safety and tolerability results for Phase 3 Subcutaneous Olanzapine Extended-Release Injection Study, or SOLARIS, trial evaluating TEV-‘749 in adult patients diagnosed with schizophrenia. In the study, TEV-‘749 met the primary endpoint, demonstrating significant improvements in the Positive and Negative Syndrome Scale total score from baseline to week 8, as well as key secondary endpoints with improvements in both the Clinical Global Impression-Severity scale and the Personal and Social Performance scale score, compared to placebo at week 8. Additionally, SOLARIS and Phase 1 safety results demonstrated no incidence of post-injection delirium/sedation syndrome in participants taking TEV-‘749 to date. The overall safety profile was consistent with other oral acting olanzapine options. These data were presented during the 37th Annual European College of Neuropsychopharmacology Congress taking place between September 21-24, 2024, in Milan, Italy. These data demonstrate the potential role of TEV-‘749 as an LAI treatment option for schizophrenia patients taking daily oral olanzapine or other antipsychotic medications. Currently, the only long-acting olanzapine treatment option for schizophrenia carries a risk for PDSS, the sudden and unexpected onset of delirium or sedation when medication is released too quickly into the blood after receiving an intramuscular injection of long-acting olanzapine.