With these long-term safety results from SOLARIS, olanzapine LAI (TEV-'749) has the potential to address a critical treatment gap by introducing a new era of long-acting olanzapine treatment,” said Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva. For P1, participants were randomized 1:1:1:1 to once-monthly olanzapine LAI (TEV-'749) (318mg, n=169; 425mg, n=169; 531mg, n=169) or placebo (n=168).1 For P2, P1 olanzapine LAI (TEV-'749) participants retained their treatment; P1 placebo participants were re-randomized to olanzapine LAI (TEV-'749) dose-groups.1Through Week 56, an integrated long-term safety analysis from the double-blind and open-label periods demonstrated a systemic safety profile for olanzapine LAI (TEV-'749) that was consistent with second-generation antipsychotic class effects and other olanzapine formulations. Across olanzapine LAI (TEV-'749) groups, one or more treatment-emergent adverse events (TEAE) were reported in 449 (74%) participants with 50 (8%) experiencing TEAEs leading to trial discontinuation. Olanzapine LAI (TEV-'749) also improved patient functioning scores, with a 4.6-point mean increase in Personal and Social Performance Scale (PSP) score from P2 baseline.1A weight and metabolic analysis of the SOLARIS trial found that long-term metabolic safety data for olanzapine LAI (TEV-'749) were consistent with currently available olanzapine formulations.1 The overall mean weight increase from baseline in participants who received olanzapine LAI (TEV-'749) for ≥48 weeks (n=137) was 5.6kg, which was comparable to those reported for oral and intramuscular olanzapine formulations. Olanzapine LAI (TEV-'749) and UZEDY utilize SteadyTeq™, a copolymer technology proprietary to MedinCell that provides a controlled steady release of olanzapine and risperidone, respectively.