Teva Pharmaceutical, in partnership with Medincell, has announced positive results from the Phase 3 SOLARIS trial evaluating its investigational Olanzapine Long-Acting Injectable (LAI) (TEV-'749 / mdc-TJK) for treating schizophrenia. The data, presented at Psych Congress 2024, demonstrate significant improvements in social functioning and quality of life in adult patients diagnosed with schizophrenia. Furthermore, real-world data on UZEDY (risperidone LAI) reveal high adherence rates and utilization in adults with schizophrenia facing barriers to treatment.
Olanzapine LAI: Improving Social Functioning and Quality of Life
The Phase 3 SOLARIS trial was an 8-week, randomized, double-blind, placebo-controlled study involving patients aged 18-64 years diagnosed with schizophrenia. The study evaluated the efficacy of TEV-'749 on social functioning and quality of life. Results indicated that TEV-'749 significantly improved social functioning and quality of life by week 8 across all three doses evaluated (318mg, 425mg, and 531mg) compared to placebo (p<0.05). The Personal and Social Performance Scale, a standard measure of social functioning, showed superior improvement with TEV-'749 compared to placebo.
Schizophrenia Quality of Life Scores also significantly improved with TEV-'749 treatment, with greater mean differences in change from baseline to week 8 observed at all doses versus placebo (p<0.05). Changes from baseline to week 8 in EuroQoL-5 Dimensions-3 Levels, another quality-of-life measure, were numerically higher at week 8 with TEV-'749 at the 425mg dose versus placebo.
Richard Malamut, Chief Medical Officer of Medincell, emphasized the impact of these findings, stating, "These new data are quite impactful as improvements in social functioning and quality of life would represent a substantial benefit for people living with schizophrenia and their families."
Absence of PDSS with Subcutaneous Delivery
A critical aspect of the Olanzapine LAI is the delivery technology developed by Medincell. The data showed that this subcutaneous delivery technology resulted in no occurrence of Post-Injection Delirium/Sedation Syndrome (PDSS) events to date. This is significant because the risk of PDSS, along with the associated post-injection monitoring requirement, has been a major barrier to the use of approved intramuscular olanzapine LAI products.
UZEDY: Real-World Adherence and Utilization
Real-world analyses of UZEDY, a risperidone long-acting injectable, reveal high adherence rates and utilization in adults with schizophrenia who have barriers to treatment. The analyses of U.S. claims data from adults living with schizophrenia who received treatment with UZEDY (n=715) examined social determinants of health (SDOH) as well as patterns of adherence. Results reveal high adherence rates in adults living with schizophrenia who have unmet social needs.
Christophe Douat, CEO of Medincell, commented, "Data presented on UZEDY usage highlights the significant social vulnerability faced by many individuals with schizophrenia, emphasizing the need for innovative and effective treatments like our risperidone LAI and investigational olanzapine LAI to address this critical societal challenge."
Implications for Schizophrenia Treatment
The positive Phase 3 results for Olanzapine LAI and the real-world data on UZEDY underscore the importance of long-acting injectable treatments for schizophrenia. These treatments offer the potential to improve adherence, social functioning, and quality of life for patients, particularly those with social vulnerabilities or barriers to treatment. The absence of PDSS with the subcutaneous Olanzapine LAI could represent a significant advantage over existing intramuscular formulations.
