New Long-term Safety Data from the Completed Phase 3 SOLARIS Trial Support the Potential of Olanzapine LAI (TEV-'749) as the First Long-Acting Olanzapine Treatment Option for Schizophrenia with No PDSS Observed

Core Insights - Teva Pharmaceuticals presented new data on its schizophrenia treatment portfolio, including long-term safety results from the SOLARIS Phase 3 trial for olanzapine LAI (TEV-'749), which showed no incidence of post-injection delirium/sedation syndrome (PDSS) [1][4] - The data also highlighted UZEDY, an extended-release injectable suspension of risperidone, which was associated with shorter hospitalization compared to Invega Sustenna, although no direct comparisons on efficacy or safety were made [1][9] Olanzapine LAI (TEV-'749) Data - The SOLARIS trial involved 675 participants aged 18-64, with a randomized double-blind placebo-controlled period followed by an open-label safety period [3][17] - No PDSS events were reported across 3,470 total injections, indicating a favorable safety profile consistent with other olanzapine formulations [4][5] - Long-term effectiveness data showed significant symptom improvement, with a mean change of -7.2 in PANSS total scores and a 4.6-point increase in PSP scores from baseline [7][8] UZEDY Data - A retrospective study indicated that UZEDY led to a 2.89-day shorter length of hospital stay compared to Invega Sustenna, translating to estimated direct cost savings of $3,200 per hospitalization [9] - UZEDY was preferred by healthcare professionals for its ease of administration and dosing characteristics, with 45% favoring it over Invega Sustenna [9][10] Company Commitment - Teva is dedicated to developing innovative treatments for complex neurological conditions, aiming to address unmet needs in mental health care [5][14] - The company plans to submit a New Drug Application (NDA) for olanzapine LAI (TEV-'749) in the second half of 2025 [13][15]