Period 2 assessed long-term safety and tolerability as a secondary objective, with end-of-treatment and follow-up visits 4 and 8 weeks after the final dose.1<\/p>\n
The primary end point was change in Positive and Negative Syndrome Scale (PANSS) total score, with Clinical Global Impression\u2013Severity (CGI-S) and Personal and Social Performance (PSP) scale scores as key secondary measures.1 Teva reported improvement in PANSS symptoms, a significant reduction in CGI-S illness severity, and improvement in PSP functioning with olanzapine LAI.1<\/p>\n
The approved doses of 318 mg, 425 mg, and 531 mg correspond to daily oral olanzapine doses of 10 mg, 15 mg, and 20 mg, respectively. Teva expects the product to become available in the US in the coming weeks.1<\/p>\n
Safety, PDSS Risk, and Long-Term Stabilization<\/p>\n
All 3 doses were similarly tolerated in SOLARIS, with weight gain, somnolence, headache, constipation, and injection site reactions among the most common adverse events. Weight gain and metabolic changes, including clinically significant weight gain, were consistent with the systemic safety profile of oral olanzapine, according to Teva. <\/p>\n
Discontinuations due to common adverse events occurred in 5% of olanzapine LAI recipients and 4% of placebo recipients.No cases of post-injection delirium\/sedation syndrome (PDSS) were observed or confirmed across 3971 injections in SOLARIS.<\/p>\n
Labeling still includes a PDSS warning, noting the syndrome has occurred with intramuscular extended-release olanzapine and its occurrence with subcutaneous dosing is unknown. Labeling also carries a boxed warning for increased mortality in elderly patients with dementia-related psychosis.1<\/p>\n
In post hoc analyses of the open-label period, more than half of participants achieved clinical stabilization, and more than 20% of those treated for 6 months or longer met remission criteria. Few patients reaching stabilization went on to relapse, Hughes reported.2<\/p>\n
Olanzapine LAI uses SteadyTeq, a copolymer technology from Medincell designed for steady, sustained drug release.1 The European Medicines Agency accepted a marketing authorization application for the agent in May 2026, and it is not yet approved in Europe.1<\/p>\n
References<\/p>\n
1. Teva announces US Food and Drug Administration (FDA) approval of Weltruza (olanzapine) for extended-release injectable suspension, as the first and only once-monthly subcutaneous injectable olanzapine for adults with schizophrenia. October 9, 2026. Accessed October 9, 2026. https:\/\/www.tevapharm.com\/news-and-media\/latest-news\/teva-announces-u.s.-food-and-drug-administration-fda-approval-of-weltruza-olanzapine-for-extended-re<\/a><\/p>\n