Israel-based Teva Pharmaceutical Industries Ltd (NYSE: TEVA) has released new positive data on social functioning and quality of life from the Phase III Subcutaneous Olanzapine Extended-Release Injection Study (SOLARIS) trial. The study assesses the efficacy of TEV-‘749 in adult patients diagnosed with schizophrenia.
SOLARIS Study Design and TEV-‘749’s Efficacy
The SOLARIS study’s Period 1 is an 8-week, randomized, double-blind, placebo-controlled trial involving patients aged 18-64 years with schizophrenia, followed by an open-label safety period of up to 48 weeks (Period 2). TEV-‘749 demonstrated significant improvements in social functioning and quality of life by week 8 across all three doses compared to placebo in a hospitalized population. The Personal and Social Performance Scale, a standard measure of social functioning, showed a mean difference in change from baseline to week 8 that was superior with TEV-‘749 at doses of 318mg, 425mg, and 531mg versus placebo (all P<0.05). Schizophrenia Quality of Life Scores also saw significant improvements with TEV-‘749, with greater mean differences in change from baseline to week 8 observed at the same doses versus placebo (all P<0.05). The EuroQoL-5 Dimensions-3 Levels, an exploratory endpoint, showed numerically higher changes at week 8 with TEV-‘749 at the 425mg dose versus placebo. TEV-‘749’s systemic safety profile was consistent with other approved oral formulations of olanzapine, with no new safety signals identified and no PDSS events reported to date.
TEV-‘749’s SteadyTeq Technology and Market Potential
TEV-‘749, an extended-release injectable suspension for subcutaneous use, is Teva’s second product utilizing SteadyTeq, a proprietary copolymer technology from MedinCell that enables sustained release of olanzapine at a therapeutic dose over a full one-month dosing interval. This technology is also used in Uzedy (risperidone) extended-release injectable suspension, which received FDA approval for the treatment of schizophrenia in adults in April 2023.- Flcube.com
