Overview

• An integrated analysis through Week 56 covering 3,470 injections reported no suspected or confirmed post-injection delirium/sedation syndrome with TEV-'749.
• Long-term systemic safety aligned with known olanzapine effects, with common events including weight gain (36%), injection-site reactions, and somnolence, and 8% discontinuing due to adverse events.
• Effectiveness was maintained in open-label treatment, with mean changes from baseline of −7.2 on PANSS total, −0.5 on CGI-S, and a +4.6 increase on PSP.
• Teva said the once-monthly subcutaneous formulation remains investigational and it intends to file a U.S. NDA in the second half of 2025 after showcasing results at Psych Congress 2025.
• Separate Teva-presented real-world analyses of UZEDY associated initiation with a 2.89-day shorter hospital stay versus Invega Sustenna and higher clinician preference for ease of use, with no head-to-head efficacy or safety comparisons.