Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for olanzapine extended-release injectable suspension (TEV-'749) for the treatment of schizophrenia in adults.
The NDA for olanzapine LAI is based on results from the Phase 3 SOLARIS trial, including Week 56 results studying its efficacy, safety and tolerability in participants aged 18 to 64 living with schizophrenia. The results validated olanzapine LAI in meeting efficacy and safety endpoints in a broad adult population of people living with schizophrenia.
The innovation of olanzapine LAI comes from its delivery of olanzapine, a foundational treatment for schizophrenia, as a once-monthly subcutaneous formulation. Teva is committed to working closely with the FDA on the review of this olanzapine LAI application as we seek to help address the critical unmet needs of people living with schizophrenia.
said Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva.
Olanzapine LAI is an investigational once-monthly subcutaneous LAI of the second-generation antipsychotic olanzapine. In the SOLARIS trial, it demonstrated an efficacy and safety profile consistent with currently available oral olanzapine formulations. It is not approved by any regulatory authority for any use at this time.
Olanzapine LAI utilizes SteadyTeq™, a copolymer technology proprietary to Medincell that provides a controlled steady, sustained release of olanzapine.
About Subcutaneous OLAnzapine Extended-Release Injection Study (SOLARIS)
SOLARIS is a multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy, safety and tolerability of olanzapine extended-release injectable suspension for subcutaneous use as a treatment in patients (ages 18-64 years) with schizophrenia. For period one of the study (first 8 weeks), 675 patients were randomized to receive a subcutaneous injection of once-monthly olanzapine LAI (TEV-'749) (low, medium or high dose) or placebo in a 1:1:1:1 ratio. For period two (next 48 weeks), patients who completed period one were randomized and equally allocated to one of the three olanzapine LAI (TEV-'749) treatment groups. The end-of-treatment and follow-up visits were 4 and 8 weeks after administration of the last treatment dose, respectively. The primary objective of the Phase 3 SOLARIS study was to evaluate the efficacy of olanzapine LAI (TEV-'749) in adult patients with schizophrenia. A key secondary objective was to further evaluate the efficacy of olanzapine LAI (TEV-'749) based on additional parameters in adult patients with schizophrenia. A secondary objective of period two of the study was to evaluate the safety and tolerability of olanzapine LAI (TEV-'749) in adult patients with schizophrenia.
For more information, read the original press release.
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