Teva Pharmaceutical has announced positive results from its Phase III SOLARIS trial (NCT05693935) evaluating TEV-'749, a subcutaneous long-acting injectable formulation of olanzapine, in adult patients with schizophrenia. The study demonstrated statistically significant improvements in social functioning and quality of life compared to placebo. These findings were presented at the Psych Congress 2024 in Boston, MA.
The SOLARIS trial consisted of two parts: an 8-week, randomized, double-blind, placebo-controlled period (Period 1) and an open-label safety extension of up to 48 weeks (Period 2). The data released pertains to Period 1, where three different doses of TEV-'749 (318 mg, 425 mg, and 531 mg) were assessed.
Improvements in Social Functioning and Quality of Life
Across all evaluated doses, TEV-'749 led to significant improvements in social functioning and quality of life by week 8 when compared to the placebo group. Eric Hughes, MD, PhD, Executive Vice President of Global R&D and Chief Medical Officer at Teva, emphasized the importance of these findings, stating, "For people living with schizophrenia receiving treatment, outside of symptom control, potential improvements in social functioning and quality of life are of fundamental importance."
Potential for Reduced PDSS Risk
Notably, TEV-'749 may offer a long-acting injectable option of olanzapine without the risk of Post-Injection Delirium/Sedation Syndrome (PDSS), a potentially life-threatening side effect associated with other long-acting olanzapine formulations. Christoph Correll, MD, Professor of Psychiatry at the Zucker School of Medicine, highlighted this benefit: "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."
Prior Efficacy Data
In September, Teva had previously reported that TEV-'749 met the primary endpoint of the SOLARIS trial, demonstrating statistically significant improvements in the Positive and Negative Syndrome Scale (PANSS) total score from baseline to week 8.
