Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., announced new findings from its innovative schizophrenia medicines portfolio presented at the 2025 Psych Congress Annual Meeting in San Diego, California.

Among the highlights were long-term safety results from the completed Phase 3 SOLARIS trial of olanzapine LAI (TEV-’749), a once-monthly, long-acting injectable subcutaneous formulation of olanzapine.

The SOLARIS data demonstrated that, through 56 weeks, no suspected or confirmed post-injection delirium/sedation syndrome (PDSS) events were reported among participants receiving olanzapine LAI (TEV-’749).

The long-term systemic safety profile was consistent with that of currently available olanzapine formulations.

Across more than 3,400 injections, the treatment maintained a safety and tolerability profile in line with the established effects of second-generation antipsychotics. The most common treatment-emergent adverse events included weight increase, injection site reactions, and somnolence, with discontinuation rates remaining low.

Effectiveness data from the trial showed sustained symptom improvement, stable reductions in Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impression-Severity (CGI-S) scores, and meaningful improvements in patient functioning.

“The first oral formulation of olanzapine was approved nearly 30 years ago and has become one of the most widely prescribed medicines for schizophrenia. With these long-term safety results, olanzapine LAI (TEV-’749) has the potential to address a critical treatment gap by offering the first long-acting olanzapine option without the risk of PDSS,” said Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva. “This innovation reflects our commitment to advancing new treatment options that make a meaningful difference in the lives of people living with complex mental health conditions.”

Professor Christoph Correll, MD, coordinating investigator of the SOLARIS study and Professor of Psychiatry at the Zucker School of Medicine, added: “These encouraging results suggest that olanzapine LAI (TEV-’749) could become a valuable new treatment option for patients who may not prefer or struggle with adherence to daily oral medications. This long-acting formulation builds on the proven efficacy of olanzapine while addressing a long-standing clinical need.”