Teva Pharmaceuticals has announced compelling long-term safety data from its completed Phase 3 SOLARIS trial, showing that olanzapine LAI (TEV-'749) demonstrated no incidence of post-injection delirium/sedation syndrome (PDSS) through 56 weeks of treatment. The investigational once-monthly subcutaneous formulation could become the first long-acting olanzapine treatment option for schizophrenia, addressing a significant unmet medical need for patients who have difficulty adhering to daily oral medications.
Breakthrough Safety Profile Eliminates PDSS Risk
The Phase 3 SOLARIS trial program enrolled 675 participants aged 18-64 years with schizophrenia in an 8-week randomized, double-blind, placebo-controlled period, followed by an open-label safety period of up to 48 weeks. Participants were randomized 1:1:1:1 to receive once-monthly olanzapine LAI at doses of 318mg (n=169), 425mg (n=169), 531mg (n=169), or placebo (n=168).
Through Week 56, the integrated long-term safety analysis revealed no suspected or confirmed PDSS events across 3,470 total injections. This represents a critical advancement, as PDSS has been a significant safety concern with other long-acting injectable antipsychotics.
"These encouraging results from the SOLARIS trial show that olanzapine LAI (TEV-'749) has the potential to be the first long-acting olanzapine treatment option that alleviates the risk of PDSS," said Christoph Correll, MD, Professor of Psychiatry at the Zucker School of Medicine and SOLARIS study coordinating investigator. "As a clinician, this is a critical development for people living with schizophrenia who may not prefer, or have difficulties adhering to daily oral treatment options."
Consistent Safety and Efficacy Profile
The systemic safety profile of olanzapine LAI proved consistent with second-generation antipsychotic class effects and other olanzapine formulations. Treatment-emergent adverse events (TEAEs) occurred in 449 (74%) participants, with 50 (8%) experiencing TEAEs leading to trial discontinuation. Serious adverse events were reported in 36 (6%) participants.
The most commonly reported TEAEs included weight increase (36%), injection site reactions such as induration (12%), pain (12%), erythema (10%), and pruritus (7%), along with somnolence (7%). Long-term metabolic safety data showed a mean weight increase of 5.6kg from baseline in participants who received treatment for ≥48 weeks (n=137), comparable to oral and intramuscular olanzapine formulations.
Maintained Clinical Effectiveness
Long-term effectiveness data demonstrated sustained symptom improvement across all olanzapine LAI dose groups. Stable changes from baseline in Positive and Negative Syndrome Scale (PANSS) total scores showed a mean improvement of -7.2 points, while Clinical Global Impression-Severity (CGI-S) scale scores improved by -0.5 points. Patient functioning also improved, with a 4.6-point mean increase in Personal and Social Performance Scale (PSP) scores from baseline.
Innovative Technology Platform
Olanzapine LAI utilizes SteadyTeq™, a copolymer technology proprietary to MedinCell that provides controlled steady release of olanzapine. This same technology platform is also used in Teva's approved UZEDY (risperidone) for schizophrenia treatment.
Addressing Critical Treatment Gap
Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva, emphasized the potential clinical impact: "The first formulation of olanzapine was approved nearly 30 years ago and is now one of the most commonly prescribed daily oral medicines for the treatment of schizophrenia. With these long-term safety results from SOLARIS, olanzapine LAI (TEV-'749) has the potential to address a critical treatment gap by introducing a new era of long-acting olanzapine treatment."
The significance of this development is underscored by the substantial burden of schizophrenia, which affects approximately 1% of the world's population and 3.5 million people in the U.S. The condition is marked by episodes of partial or full remission broken by relapses, with approximately 80% of patients experiencing multiple relapses over the first five years of treatment.
Regulatory Timeline
Teva Pharmaceuticals plans to proceed with a New Drug Application (NDA) submission for olanzapine LAI in the second half of 2025. The investigational treatment is not currently approved by any regulatory authority, and its safety and efficacy are not yet established outside of clinical trial settings.
Additional UZEDY Data
Separately, Teva presented data on UZEDY showing potential healthcare economic benefits. A retrospective observational study found that UZEDY initiation was associated with 2.89 days shorter hospital stays compared to Invega Sustenna (paliperidone palmitate) (12.57 vs 15.46 days, P=0.033), translating to estimated direct cost savings of $3,200 per hospitalization. Healthcare professionals showed overall preference for UZEDY (45% vs 38%) due to its dosing characteristics and ease of use.
