Teva’s Novel Schizophrenia Drug Candidate Demonstrates High Patient, Provider Satisfaction in Phase III Trial Survey

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Results from the Phase III SOLARIS trial survey highlighted strong patient and healthcare provider satisfaction with TEV-'749 (olanzapine), a once-monthly subcutaneous long-acting injectable (LAI) formulation of olanzapine for schizophrenia. According to the company, full data were presented at the 2025 Congress of the Schizophrenia International Research Society.¹

“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, EVP, global R&D, chief medical officer, Teva, in a press release. “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.”

The multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled SOLARIS study evaluated the efficacy, safety, and tolerability of TEV-'749 in 675 adult patients. During the first eight weeks of the study, patients were randomized to receive either a low, medium, or high dose of once-monthly subcutaneous TEV-'749 or placebo in a 1:1:1:1 ratio. Patients who completed the first part of the study were then randomized to one of the three TEV-'749 treatment groups for an additional 48 weeks. The primary endpoint of the study was to evaluate the efficacy of TEV-'749, while a key secondary endpoint further assessed efficacy based on additional clinical parameters in adult patients with schizophrenia.

Survey results showed that over 92% of patients, 87% of nurses, and 72% of physicians were satisfied with TEV-'749’s initiation regimen, dosing schedule, and overall treatment experience. Notably, 78.6% of patients preferred the subcutaneous injection over the intramuscular option, citing needle size as a primary factor. Additionally, most participants expressed a preference for an LAI without post-injection monitoring (90% of patients, over 90% of physicians, and 66% of nurses). The convenience of a monthly dosing schedule was also highly valued (patients: 61.4%; physicians: 72.7%; nurses: 66.7%).¹

According to the World Health Organization, schizophrenia affects approximately 24 million people worldwide, with a prevalence of one in every 222 adults. Onset is most common in late adolescence and early adulthood, with men experiencing onset earlier than women. Patients with schizophrenia face a two- to three-fold higher risk of premature death, primarily due to cardiovascular diseases. While a significant number of individuals with schizophrenia lack access to proper treatment, nearly 50% of all mental hospital patients are diagnosed with the disorder.²

In the United States, it is estimated that the prevalence range of schizophrenia is between 0.25% and 0.64%. According to the National Institute of Mental Health, 4.9% of people with schizophrenia die by suicide, considerably higher than the rest of the global population.³

“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, chief medical officer, Neuroscience Education Institute, in the press release. “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.”

References

1. New Data Strengthens Teva’s Schizophrenia Portfolio, Including Phase 3 SOLARIS Trial Survey Results Demonstrating Patient and Healthcare Professional Satisfaction with TEV-'749 (olanzapine) as a Once-Monthly Subcutaneous Long-Acting Injectable. Teva. March 31, 2025. Accessed April 2, 2025. https://www.tevapharm.com/news-and-media/latest-news/new-data-strengthens-tevas-schizophrenia-portfolio-including-phase-3-solaris-trial-survey-results-demon/
2. Schizophrenia. WHO. January 10, 2022. Accessed April 2, 2025. https://www.who.int/news-room/fact-sheets/detail/schizophrenia#:~:text=Schizophrenia%20affects%20approximately%2024%20million%20people%20or,as%20common%20as%20many%20other%20mental%20disorders.
3. Schizophrenia. NIH. Accessed April 2, 2025. https://www.nimh.nih.gov/health/statistics/schizophrenia