The US FDA has approved Weltruza (olanzapine) for extended-release injectable suspension as a once-monthly subcutaneous long-acting injectable (LAI) for schizophrenia in adults, Teva Pharmaceutical Industries (NYSE: TEVA) announced. The formulation requires no loading doses, no oral supplementation, and no post-injection monitoring.
Weltruza uses Medincell's proprietary SteadyTeq copolymer technology to provide sustained release of olanzapine, an atypical antipsychotic that acts primarily through dopamine D2 and serotonin 5-HT2A receptor antagonism. Unlike the existing intramuscular olanzapine long-acting injection Zyprexa Relprevv, which requires at least three hours of post-injection observation because of the risk of post-injection delirium/sedation syndrome (PDSS), Weltruza has no such monitoring requirement.
The approval is based on the pivotal Phase III SOLARIS trial, a randomized, double-blind, placebo-controlled study in 675 patients with schizophrenia, in which Teva said trial results demonstrated improvement in symptoms, a significant reduction in illness severity, and improvement in personal and social functioning. The approved once-monthly doses of 318 mg, 425 mg, and 531 mg correspond to oral olanzapine daily doses of 10 mg, 15 mg, and 20 mg, respectively.
In SOLARIS, the most common adverse events were weight gain, somnolence, headache, constipation, and injection site reactions; discontinuations due to adverse events were 5% with active treatment and 4% with placebo. The label carries a boxed warning for increased mortality risk in elderly patients with dementia-related psychosis.