Post Hoc SOLARIS Data Support Stabilization and Remission With Subcutaneous Olanzapine

Eric Hughes, MD, PhD, described post hoc findings from the phase 3 SOLARIS trial of TEV-'749, an investigational once-monthly subcutaneous olanzapine formulation, in which more than half of participants achieved clinical stabilization and more than 20% of those treated for 6 months or longer met remission criteria.¹ Hughes noted that few patients who reached stabilization subsequently relapsed, with stabilization defined as at least 4 consecutive weeks of sustained criteria during the open-label period, including a Positive and Negative Syndrome Scale total score of 80 or lower and a Clinical Global Impression–Severity score of 4 or lower. In a simulated switching analysis, initiating TEV-'749 1 day after the last dose of oral or short-acting intramuscular olanzapine maintained drug levels within established therapeutic ranges. Across 3971 injections, no cases of post-injection delirium/sedation syndrome were observed or confirmed, with no indication for post-injection monitoring, in contrast to the 3 hours of monitoring in a certified health care setting required under the Risk Evaluation and Mitigation Strategy for existing intramuscular long-acting olanzapine.² Metabolic analyses showed a profile consistent with daily oral olanzapine, with no unexpected signals or dose-dependent patterns, suggesting that clinicians could follow standard olanzapine guidelines for monitoring weight, lipids, and glucose if TEV-'749 were to be approved.

Psychiatric Times: What are the clinical highlights from the latest phase 3 data on TEV-'749?

Eric Hughes, MD, PhD: What’s encouraging about this post-hoc analysis of the phase 3 SOLARIS findings is the consistency of the efficacy results observed during longer-term treatment. More than half of participants receiving TEV-'749 achieved clinical stabilization, and remarkably, over 20%, of patients receiving TEV-'749 for 6 months or longer, met the criteria for remission, marked by a Positive and Negative Syndrome Scale item score of 3 or lower across 8 specific remission categories.

Additionally, for those patients who reached stabilization, few relapsed. When you're managing a chronic and complex condition like schizophrenia, the potential to maintain symptom control and reduce or prevent relapse is extremely important.

PT: How was stabilization defined in the SOLARIS post hoc analysis, and how should clinicians interpret results from the open-label period?

Hughes: We set a rigorous bar for stabilization in this post-hoc analysis. Specifically, patients had to maintain stability for at least 4 consecutive weeks during Period 2. The criteria included a PANSS total score of 80 or lower; low scores across 4 core psychotic symptoms, including conceptual disorganization and hallucinations, a Clinical Global Impression–Severity score of 4 or lower, stable outpatient status, and no suicidal ideation or behavior. For clinicians, these results demonstrate the potential of TEV-'749 to help manage symptoms and support long-term clinical stability.

PT: Could clinicians switch directly from oral or short-acting IM olanzapine without an overlap period?

Hughes: That’s a critical question. In our simulated switching analysis, initiating TEV-'749 one day after a patient’s last dose of oral or short-acting intramuscular olanzapine-maintained drug levels within established therapeutic ranges.

PT: What did SOLARIS show about post-injection delirium/sedation syndrome, and would patients need post-injection monitoring?

Hughes: This is arguably one of the most important aspects of the SOLARIS program. Across 3971 injections of TEV-'749 during the trial, there were no observed or confirmed cases of post-injection delirium/sedation syndrome. Oral olanzapine has been a cornerstone treatment for a long time, but the existing IM long-acting injectables on the market carry a strict REMS requirement, including three hours of post-injection monitoring in a certified healthcare setting. In the phase 3 SOLARIS trial, TEV-'749 administered as a once-monthly subcutaneous injection demonstrated an efficacy and safety profile consistent with currently available olanzapine formulations and showed no evidence for the need for post-injection monitoring.

PT: Given the metabolic profile matches oral olanzapine, how should clinicians approach metabolic monitoring?

Hughes: These new metabolic analyses reinforced a metabolic profile of TEV-'749 that is consistent with daily oral olanzapine, with no unexpected signals or dose-dependent patterns. If approved, clinicians may be able to follow standard olanzapine guidelines for monitoring weight, lipids, and glucose.

PT: What practical advantages does subcutaneous administration offer over intramuscular LAIs?

Hughes: The currently available intramuscular formulation of olanzapine has specific safety requirements, including a mandated 3-hour post-injection monitoring in a certified healthcare facility. If approved, TEV-749 could become the first and only once-monthly long-acting injectable formulation of olanzapine that does not require loading doses or oral supplementation at treatment initiation.

Dr Hughes is executive vice president, global R&D and chief medical officer at Teva Pharmaceuticals.

References

1. Teva announces new olanzapine LAI (TEV-'749) post hoc data highlighting high rates of stabilization and long-term efficacy as once-monthly subcutaneous injectable for the treatment of schizophrenia in adults. Press release. Published September 18, 2026. Accessed October 1, 2026. https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2026/Teva-Announces-New-Olanzapine-LAI-TEV-749-Post-Hoc-Data-Highlighting-High-Rates-of-Stabilization-and-Long-Term-Efficacy-as-Once-Monthly-Subcutaneous-Injectable-for-the-Treatment-of-Schizophrenia-in-Adults/default.aspx

2. Cherniakov I, Merenlender Wagner A, Eshet R, et al. Safety, tolerability, and pharmacokinetics of subcutaneous extended-release injectable olanzapine in patients with schizophrenia and schizoaffective disorder. Clin Drug Investig. 2026;46(3):307-320.