Teva presents latest schizophrenia portfolio data including real-world outcomes with UZEDY® (risperidone) showing lower rates of and longer time to relapse
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. have announced the presentation of real-world clinical outcomes, treatment patterns and healthcare resource utilization (HCRU) data evaluating UZEDY® (risperidone), an extended-release injectable suspension of risperidone for subcutaneous use every one or two months for the treatment of schizophrenia in adults, versus second-generation daily oral options. In the studies, patients receiving UZEDY had lower rates of and longer time to relapse as well as better treatment adherence and persistence rates, fewer inpatient, outpatient and emergency department (ED) visits, shorter hospital length of stay and lower all-cause HCRU.
Additionally, Phase 3 SOLARIS data show no incidence of post-injection delirium/sedation syndrome (PDSS) to date in participants taking TEV-'749, a once-monthly, long-acting injectable (LAI) subcutaneous formulation of olanzapine. The systemic safety profile was consistent with approved olanzapine options. The data were presented at the 2025 Psych Congress Elevate Annual Meeting, taking place from May 28-31, 2025, in Las Vegas, Nevada.
People living with schizophrenia and their caregivers face a number of significant daily challenges, including barriers to optimal treatment. For those who struggle adhering to a daily oral regimen, UZEDY may be an appropriate option to help prevent relapse, reduce hospital visits and lower overall costs to the healthcare system. With TEV-'749, our latest data demonstrate its potential to fill a critical gap in the current schizophrenia treatment landscape as a long-acting formulation of olanzapine that may effectively address the risk of PDSS.
said Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva.
UZEDY Data
Two retrospective cohort studies evaluating UZEDY explored claims data comparing outcomes in adults living with schizophrenia who were continuously enrolled in Medicaid, Medicare or commercial health plans. Patients were followed for two years before and six months after starting UZEDY (n=720), second generation oral antipsychotics (SGOA) (n=720) or oral risperidone (n=720). Key findings are summarized below:
Real-World Clinical Outcomes
- UZEDY was associated with a lower relapse rate (9.0% vs. 15.4% for SGOAs and 16.8% for oral risperidone) and a longer mean time to relapse (94 days vs. 61 days for SGOAs and 69 days for oral risperidone).
Real-World Treatment Patterns and HCRU (UZEDY versus SGOAs)
- A higher percentage of individuals on UZEDY demonstrated good adherence (medication possession ratio ≥0.8; 71.3% vs. 52.8% for SGOAs) and treatment persistence by staying on treatment longer (120 days vs. 96 days for SGOAs).
- UZEDY was also associated with shorter hospital stays (8 days vs. 16 days for SGOAs) and lower proportions of patients requiring inpatient (15% vs. 29.6% for SGOAs) or ED visits (22.5% vs. 31.7% for SGOAs). Additionally, patients on UZEDY had fewer outpatient visits (6.3 vs. 8.6 per person/year for SGOAs).
- Mean all-cause HCRU costs were lower among adult patients on UZEDY ($18,796 vs. $26,376 for SGOAs).
TEV-'749 Data
In Period 1 of the SOLARIS trial, TEV-'749 met its primary efficacy endpoint across all three dosing groups (318mg, 425mg, 531mg), with statistically significant mean differences in the change in Positive and Negative Syndrome Scale (PANSS) total scores from baseline to week 8 (-9.75 points, -11.27 points, and -9.76 points, respectively) versus placebo. Additional safety results from Period 1 (3,487 active injections) show no suspected or confirmed PDSS events reported as of March 2025. The systemic safety profile of TEV-'749 was consistent with other approved formulations of olanzapine, with no new safety signals identified.
With nearly 30 years of clinical and real-world use, olanzapine is one of the most commonly prescribed SGOAs for schizophrenia around the world. Its efficacy and safety profiles are well established.
For more information including the full data, read the original release.
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