Teva Unveils Phase 3 Data on Monthly Injectable Olanzapine for Schizophrenia

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., recently announced promising results from its Phase 3 SOLARIS trial, focused on TEV-‘749, an investigational long-acting injectable for schizophrenia. This trial, conducted on adult patients, revealed significant efficacy and safety outcomes. TEV-‘749 demonstrated notable improvements in the Positive and Negative Syndrome Scale (PANSS) total score from baseline to week 8. Additionally, it showed positive changes in secondary endpoints, including the Clinical Global Impression-Severity (CGI-S) scale and the Personal and Social Performance (PSP) scale.

A key highlight from the SOLARIS study is the lack of incidence of Post-Injection Delirium/Sedation Syndrome (PDSS) in participants. This is significant because current long-acting olanzapine treatments for schizophrenia carry a risk of PDSS, a severe condition that can occur when the medication is rapidly released into the bloodstream after injection. The safety profile of TEV-‘749 aligns with existing oral olanzapine treatments, suggesting it could be a safer long-acting option.

Eric Hughes, MD, PhD, Executive Vice President of Global R&D and Chief Medical Officer at Teva, emphasized the company's dedication to addressing unmet needs in schizophrenia treatment. He pointed out that the absence of PDSS in the SOLARIS trial could help overcome barriers associated with current intramuscular olanzapine LAIs, thereby supporting the ongoing development of TEV-‘749.

Christoph Correll, MD, Professor of Psychiatry at the Zucker School of Medicine, underscored the importance of developing a long-acting olanzapine formulation without the risk of PDSS. He noted that the SOLARIS trial data suggest TEV-‘749 may fulfill this need, offering a critical option for patients and healthcare providers requiring long-acting treatments.

The SOLARIS trial is structured in two periods. Period 1 is an 8-week, randomized, double-blind, placebo-controlled trial involving patients aged 18-64 years. It is followed by Period 2, an open-label safety period lasting up to 48 weeks. The initial results from Period 1 are promising, with TEV-‘749 meeting its primary endpoint across all three dosing groups. The mean differences in PANSS total scores from baseline to week 8 were statistically significant for high, medium, and low dose groups compared to placebo.

Moreover, TEV-‘749 showed significant improvements in CGI-S and PSP scale scores across all dosing groups. The systemic safety profile was consistent with other approved olanzapine formulations, with no new safety issues identified. Notably, no PDSS cases were reported, and common adverse events included weight increase, injection site reactions, and minor injection site pain.

Results from a related Phase 1 study further support the safety and tolerability of TEV-'749, showing no PDSS events. A pre-clinical study suggests that the subcutaneous administration and specific formulation of TEV-'749 significantly lower the risk of PDSS.

Long-term safety and incidence of PDSS are being evaluated in the ongoing SOLARIS open-label study (Period 2). Preliminary safety data are expected to be available in the first half of 2025.

TEV-‘749 employs Medincell’s proprietary SteadyTeq™ technology, facilitating a controlled release of olanzapine. While TEV-‘749 is still investigational and not yet approved by regulatory authorities, its development marks a significant step in providing new treatment options for schizophrenia, potentially improving patient outcomes and adherence.

Schizophrenia is a chronic mental disorder affecting about 1% of the global population and 3.5 million people in the U.S. It often requires long-term treatment and management, with frequent relapses and significant healthcare costs. Teva's dedication to innovative schizophrenia treatments like TEV-‘749 underscores its commitment to enhancing patient care and addressing the challenges associated with this debilitating condition.