Teva and Medincell declared positive data for TEV-‘749 in schizophrenia trial

Teva and Medincell have disclosed positive outcomes from the Phase III Subcutaneous OLAnzapine Extended-Release Injection Study (SOLARIS), assessing TEV-‘749 (olanzapine) as a monthly subcutaneous long-acting injectable for adults with schizophrenia. SOLARIS, a multinational, randomized, double-blind, placebo-controlled trial, evaluates olanzapine's efficacy, safety, and tolerability in 18-65-year-old schizophrenia patients. The Phase III SOLARIS trial shows promising outcomes for TEV-‘749, a monthly subcutaneous olanzapine injection developed by Teva. It met its primary goal, demonstrating significant symptom severity reduction based on the Positive and Negative Syndrome Scale (PANSS) total score. TEV-‘749, utilizing Medincell’s SteadyTeq technology, was well tolerated across all dosage groups, with no observed incidence of post-injection delirium/sedation syndrome (PDSS) to date. Moreover, TEV-‘749 showed statistically significant performance in key secondary endpoints, including the Clinical Global Impressions – Schizophrenia (CGI-S) and Personal and Social Performance Scale (PSP).