India Pharma Outlook Team | Tuesday, 23 September 2025
Teva Pharmaceuticals, the U.S. branch of Teva Pharmaceutical Industries Ltd., shared the promising new long-term data of its schizophrenia drug portfolio at the 2025 Psych Congress Annual Meeting in San Diego, California. It was mainly about the Phase 3 SOLARIS trial evaluating olanzapine LAI (TEV-’749), a once-monthly, subcutaneous long-acting injectable formulation of olanzapine.
The systemic safety profile was compatible with the standard olanzapine formulations, and the treatment showed good safety across more than 3,400 injections. The most common treatment-emergent adverse events were weight gain, injection site reactions, and somnolence, with discontinuation rates being low.
The efficacy measures pointed out to be mainly symptom remission, stable reductions in the Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impression-Severity (CGI-S) scores were observed, along with significant changes in patient functioning.
Eric Hughes, MD, PhD, Executive Vice President, Global R&D, and Chief Medical Officer at Teva commented, “With this kind of long-term safety olanzapine LAI is the first long-acting olanzapine that comes without PDSS risk thus it is able to cover a critical treatment gap for complex mental health patients.”
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Professor Christoph Correll, MD, coordinating investigator of SOLARIS, stated, “OLanzapine LAI might evolve into a good alternative to last for patients that pverse and have difficulties to comply with daily oral medications, taking advantage of olanzapine’s well-established strengths while solving a long-standing clinical problem.”
Aside from safety, this breakthrough underpins Teva’s pledge to innovative, patient-centric interventions in schizophrenia treatment, which facilitates long-term treatment.
