Teva’s New Schizophrenia Treatment Shows Success In Latest Phase 3 Study

Teva Pharmaceuticals, a U.S. branch of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), has shared encouraging results from its Phase 3 SOLARIS trial, which tested TEV-‘749, a monthly injectable form of olanzapine, in adults with schizophrenia. The study showed that TEV-‘749 achieved its primary goal by significantly reducing symptoms measured by the Positive and Negative Syndrome Scale (PANSS) from the start of the study to week 8. 

It also met secondary goals, showing improvements in the Clinical Global Impression-Severity (CGI-S) and Personal and Social Performance (PSP) scales compared to placebo after 8 weeks. Importantly, there were no reported cases of post-injection delirium/sedation syndrome (PDSS) during the SOLARIS (Period 1) and Phase 1 safety tests. The safety profile of TEV-‘749 was similar to other oral olanzapine treatments. These findings were presented at the 37th Annual European College of Neuropsychopharmacology (ECNP) Congress, held in Milan, Italy, from September 21-24, 2024.

Schizophrenia is a multifaceted condition that often necessitates adjustments in treatment, including switching from oral medications to long-acting injectables (LAIs) or between different LAI therapies. New findings highlight the potential of TEV-749 as an LAI option for patients currently managing their symptoms with daily oral olanzapine or other antipsychotics. Presently, the only long-acting olanzapine available poses a risk of PDSS, a condition where sudden episodes of delirium or sedation occur due to the rapid release of the drug into the bloodstream following intramuscular injection.

Eric Hughes, MD, PhD, Executive Vice President of Global R&D and Chief Medical Officer at Teva, said in a statement, “Teva is dedicated to building on its commitment to neuroscience by developing new long-acting injectable treatment options like TEV-‘749 that may help address unmet needs in schizophrenia for patients and healthcare providers. PDSS is a major barrier to the utilization of intramuscular olanzapine LAIs that exists today, and our SOLARIS findings fuel the continued development of TEV-‘749.”

Christoph Correll, MD, Professor of Psychiatry at the Zucker School of Medicine, Hempstead, NY, stated “Developing a long-acting olanzapine formulation that poses potentially no risk of PDSS is crucial in preventing these dangerous episodes that otherwise limit the use of olanzapine to daily oral options. With no PDSS observed in the SOLARIS trial to date, these data add to the growing body of evidence that TEV-‘749 may one day serve as an important treatment option for patients and healthcare providers who rely on olanzapine and also have needs or preferences that require a long-acting option.”

For almost three decades, olanzapine has been widely utilized as one of the most frequently prescribed second-generation oral antipsychotics for treating schizophrenia globally. Its effectiveness and safety have been consistently demonstrated in both clinical and real-world settings.