Israel-based based Teva Pharmaceuticals has taken a major step toward expanding treatment options for schizophrenia, filing a New Drug Application with the US Food and Drug Administration for its once-monthly olanzapine extended-release injectable suspension.
The submission for TEV-’749 follows promising Phase 3 data from the SOLARIS trial, which tracked the drug’s efficacy, safety and tolerability over 56 weeks in adults ages 18 to 64.
Teva says the findings confirm that the long-acting injectable (LAI) formulation hit key clinical endpoints across a broad adult population 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,” said Eric Hughes, Executive Vice President, Global R&D and Chief Medical Officer at Teva. “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.”
The investigational therapy uses SteadyTeq, a proprietary copolymer technology from Medincell designed to release olanzapine steadily over time. In the SOLARIS study, the injectable showed an efficacy and safety profile in line with existing oral olanzapine. It is not yet approved for any use by regulators.
SOLARIS, a multinational, randomized, double-blind, placebo-controlled Phase 3 trial, enrolled 675 adults for an initial eight-week period in which participants received one of three doses of the monthly injection or placebo. Those who completed the first phase moved into a 48-week extension focused on long-term efficacy, safety and tolerability. Follow-up continued up to eight weeks after the final dose.
The primary goal: determine how well the long-acting formulation controls schizophrenia symptoms. Secondary measures further assessed symptom reduction and monitored safety across nearly a year of treatment.
Teva’s application now heads to the FDA for review—positioning the company to potentially introduce a new, longer-acting alternative for patients who rely on consistent, sustained antipsychotic therapy, as per the company.
