Teva Reports Positive Phase 3 Results For TEV-749 In Schizophrenia Treatment

(RTTNews) - Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (TEVA), announced new positive efficacy, safety and tolerability results for Phase 3 Subcutaneous Olanzapine Extended-Release Injection Study (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 (PANSS) total score from baseline to week 8, as well as key secondary endpoints with improvements in both the Clinical Global Impression-Severity (CGI-S) scale and the Personal and Social Performance (PSP) scale score, compared to placebo at week 8, the company said.

In addition, SOLARIS (Period 1) and Phase 1 safety results demonstrated no incidence of post-injection delirium/sedation syndrome (PDSS) in participants taking TEV-'749 to date. The overall safety profile was consistent with other oral acting olanzapine options.

Schizophrenia is a complex medical condition that may require switching from oral options or between different long-acting injectable (LAI) options during the patient treatment journey. The 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 post-injection delirium/sedation syndrome, 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.

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