- More than 92% of schizophrenia patients taking TEV-'749 in the SOLARIS survey were satisfied or very satisfied with the initiation regimen, dosing schedule and trial medication1
- New data from UZEDY® (risperidone) evaluated predictors of response in schizophrenia with efficacy observed across patient demographic and clinical characteristics in the Phase 3 RISE trial
- Teva continues its commitment to generating clinical insights that help advance and support optimal treatment for individuals living with schizophrenia
PARSIPPANY, N.J. and TEL AVIV, Israel, March 31, 2025 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced the presentation of a patient and healthcare professional (HCP) attitudes and experiences survey study, complementing the successful Phase 3 Subcutaneous Olanzapine Extended-Release Injection Study (SOLARIS) evaluating TEV-'749. More than 92% of patients, 87% of nurses and 72% of physicians were either satisfied or very satisfied when asked about TEV-'749, overall, including initiation regimen, monthly dosing schedule and dosing options.1 The data were presented at the 2025 Congress of the Schizophrenia International Research Society (SIRS) taking place from March 29 to April 2, 2025, in Chicago, IL.
“Schizophrenia is an incredibly complex condition with profound impacts on mental health and daily life. That’s why understanding the treatment perspectives of patients and healthcare providers is integral to Teva’s research, and these survey results underscore the personal approach we’ve taken with the development of TEV-'749,” said Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva. “This early clinical feedback on TEV-'749 is encouraging across some of the most important schizophrenia treatment factors – dosing schedule, initiation regimen, subcutaneous administration, post-injection monitoring requirements and general satisfaction.”
With nearly 30 years of clinical and real-world use, olanzapine is one of the most commonly prescribed second-generation oral antipsychotics for the treatment of schizophrenia globally, with a well-established efficacy and safety profile. Teva’s Phase 3 SOLARIS trial program is evaluating the potential of TEV-'749 and its innovative drug delivery technology as a long-acting injectable (LAI) subcutaneous formulation of olanzapine that may also help address the risk of Post-Injection Delirium/Sedation Syndrome (PDSS).
“Olanzapine is foundational to the treatment of schizophrenia; however, I have seen first-hand the adherence challenges faced by patients and caregivers with daily oral options,” said Andrew J. Cutler, MD, Clinical Associate Professor of Psychiatry, SUNY Upstate Medical University and Chief Medical Officer, Neuroscience Education Institute. “The potential of TEV-'749 as a long-acting formulation of olanzapine that also may not carry a risk for PDSS and the accompanying risk evaluation & mitigation strategy (REMs) and post-injection observation period could be instrumental in helping to treat more people with schizophrenia.”
The prospective, cross-sectional, observational and online survey study recruited patient (n=70) and HCP participants (nurses: n=24; physicians: n=11) taking part in the SOLARIS trial who had two or more experiences with TEV-'749. The survey collected information on participants’ demographics and clinical characteristics as well as their attitudes on and experiences with LAI treatment attributes, delivery of care, and treatment satisfaction.
Additional survey findings include:
- Injection-type preference: Patient preference for subcutaneous (SC) versus intramuscular (IM) injection (78.6% vs. 21.4%, respectively), with 67.3% of patients indicating the needle size as the main reason for their preference.1 For HCPs, SC versus IM preference was balanced for physicians (54.6% vs. 45.5%, respectively) and nurses (both 50.0%).1
- Post-injection monitoring requirements: Despite reporting low levels of social, emotional, financial or time impact, nearly all patients noted it would be helpful to have an LAI without a post-injection monitoring period (90.0%) or caregiver accompaniment requirement (92.9%).1 The majority of physicians (>90%) and nurses (>66%) responded that the post-injection monitoring period may present potential treatment barriers and clinical challenges that could impact patients’ use of LAIs.1 Currently available olanzapine LAI has a three-hour post-injection monitoring requirement.2
- Initiation regimen: When starting an LAI, most participants preferred an initiation regimen requiring only one injection versus more complex regimens requiring concomitant oral medications or multiple injections (patients: 72.9% vs. 27.1%; physicians: 90.9% vs. 9.1%; nurses: 79.2% vs. 20.8%).1
- Dosing schedule: A majority of participants valued a monthly dosing schedule “a lot” (patients: 61.4%; physicians: 72.7%; nurses: 66.7%).1
- TEV-'749 satisfaction: Almost all participants had favorable responses (satisfied or very satisfied) regarding the initiation regimen, dosing schedule and trial medication overall (patients: >92%; physicians: >72%; nurses: >87%), and responded favorably regarding continuing TV-44749 (patients: 82.9%; physicians: 63.6%; nurses: 70.8%).1 Patients who had prior experience with LAIs were more likely to indicate they were “very satisfied” with trial medication overall (61.9% vs 53.1%). HCPs with more (≥10) TV-44749 experiences were more likely to rate it favorably (88.9% vs 76.5%) and be willing to continue treatment with TV-44749 (83.3% vs 52.9%).1
Below is the full set of schizophrenia data presented by Teva at SIRS 2025:
TEV-'749 (olanzapine):
- (De novo) Patient and healthcare professional attitudes and trial experiences with a subcutaneous long-acting injectable olanzapine (TV-44749) for the treatment of schizophrenia
UZEDY (risperidone):
- (De novo) Predictors of response and non-response to treatment for schizophrenia: machine learning analysis of patients treated with TV-46000 or placebo in the RISE study
Schizophrenia Treatment Landscape:
- (De novo) Healthcare professionals’ attitudes toward use of long-acting injectable antipsychotics for schizophrenia treatment differ among settings of care: ADVANCE survey results
- (De novo) The evolving schizophrenia treatment landscape in the United States: A real-world claims analysis of treatment patterns and use of long-acting injectable antipsychotics
- (De novo) Real-world antipsychotic prescription patterns among patients with schizophrenia in Australia: Results from the ARIEL study
- (De novo) Country-specific factors influencing patients’ willingness to use a long-acting injectable antipsychotic to treat schizophrenia: patient and caregiver ADVANCE survey results
- (De novo) Patient and caregiver engagement to support the development of clinical trials in adolescents living with schizophrenia
TEV-'749 is an investigational once-monthly subcutaneous LAI of the second-generation antipsychotic olanzapine and is not approved by any regulatory authority for any use, and its safety and efficacy are not established. The long-term safety of TEV-'749 and incidence of PDSS are being evaluated in the SOLARIS open-label study (Period 2).
TEV-'749 and UZEDY utilize SteadyTeq™, a copolymer technology proprietary to MedinCell that provides a controlled steady release of olanzapine and risperidone, respectively.
UZEDY was approved in the U.S. for the treatment of schizophrenia in adults in 2023.1
About Subcutaneous OLAnzapine Extended-Release Injection Study (SOLARIS)
SOLARIS is a multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy, safety and tolerability of olanzapine extended-release injectable suspension for subcutaneous use as a treatment in patients (ages 18-65 years) with schizophrenia. For period one of the study (first 8 weeks), 675 patients were randomized to receive a subcutaneous injection of once-monthly TEV-'749 (low, medium or high dose) or placebo in a 1:1:1:1 ratio. For period two, which will last for up to 48 weeks, patients who completed period one are randomized and equally allocated to one of the three TEV-'749 treatment groups. The end-of-treatment and follow-up visits will be at 4 and 8 weeks after administration of the last treatment dose, respectively. The primary objective of the Phase 3 SOLARIS study was to evaluate the efficacy of TEV-'749 in adult patients with schizophrenia. A key secondary objective was to further evaluate the efficacy of TEV-'749 based on additional parameters in adult patients with schizophrenia. A secondary objective that is still ongoing through period two of the study is to evaluate the safety and tolerability of TEV-'749 in adult patients with schizophrenia.
About UZEDY
UZEDY (risperidone) extended-release injectable suspension for subcutaneous use is indicated for the treatment of schizophrenia in adults. In clinical trials, UZEDY significantly reduced the risk of schizophrenia relapse.1,3 UZEDY administers risperidone through copolymer technology under license from MedinCell that allows for rapid absorption and sustained release after subcutaneous injection. UZEDY is the only long-acting, subcutaneous formulation of risperidone available in both one- and two-month dosing intervals.
