A positive efficacy, safety, and tolerability profile has emerged from Medincell and Teva’s Phase 3 SOLARIS trial evaluating Olanzapine LAI in patients with schizophrenia.
Key Findings
• Efficacy results at 8 weeks in Period 1 demonstrated significant patient improvements across multiple parameters.
• Systemic safety data aligned with other olanzapine formulations; no new safety signals were identified.
• No cases of post-injection delirium sedation syndrome (PDSS) have been observed to date, which is significant as it removes a major barrier to using intramuscular olanzapine LAI.
The SOLARIS trial is a randomized, double-blind, placebo-controlled study followed by an open-label safety period. It enrolled patients aged 18-64 diagnosed with schizophrenia.
Olanzapine LAI is an investigational once-monthly subcutaneous injection of Olanzapine, an atypical antipsychotic. Its potential to be the first long-acting Olanzapine with a favorable safety profile differentiates it from other LAIs of Olanzapine, which carry an FDA black box warning for PDSS.
Long-term safety and the incidence of PDSS are being assessed in the ongoing open-label Period 2 of the SOLARIS study, with topline results anticipated in the first half of 2025.
Teva is leading the development and commercialization of Olanzapine LAI. Medincell, its partner, is eligible for up to $117 million in development and commercial milestones and royalties on net sales.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
