New data presented at Psych Congress 2024 highlights the potential of long-acting injectables (LAIs) in schizophrenia treatment, particularly regarding improved safety and adherence. Teva and Medincell shared findings from the Phase III SOLARIS trial of TEV-'749 (olanzapine LAI) and real-world analyses of UZEDY® (risperidone) LAI, offering new hope for patients and clinicians.
TEV-'749: Enhanced Social Functioning and Safety
The Phase III SOLARIS trial (NCT05693935) demonstrated that TEV-'749 significantly improved social functioning and quality of life in adults with schizophrenia within the initial eight weeks of treatment. According to Medincell, TEV-'749 has the potential to be the first long-acting olanzapine medication with a more favorable safety profile. A key advantage is the absence of post-injection delirium/sedation syndrome (PDSS), a serious side effect associated with existing olanzapine LAIs, which carries a U.S. FDA black box warning.
Richard Malamut, Chief Medical Officer of Medincell, emphasized the importance of this finding: "The risk of PDSS, along with the associated post-injection monitoring requirement, has been a major barrier to the use of the approved intramuscular olanzapine LAI product." The absence of PDSS in the TEV-'749 trials could significantly expand the use of olanzapine LAIs.
Dr. Christoph Correll, Professor of Psychiatry at the Zucker School of Medicine, stated, "We may soon be able to offer schizophrenia treatment for patients taking daily oral olanzapine with a long-acting injectable option that may reduce the risk of this potentially life-threatening side effect." Malamut added that improvements in social functioning and quality of life would represent a substantial benefit for people living with schizophrenia and their families.
UZEDY®: High Adherence in Real-World Settings
Teva also presented real-world analyses showing that subcutaneous UZEDY® (risperidone) LAI achieved high use and adherence rates in adults with schizophrenia who face barriers to treatment. Notably, a lines of therapy analysis revealed that UZEDY® was used as a first-line option in 12% of cases. This suggests that UZEDY® is being considered as an early intervention for some patients, potentially improving long-term outcomes.
Teva is leading the clinical development, regulatory process, and commercialization of both UZEDY® and TEV-'749.
