Teva Pharmaceutical Industries (TEVA) Study Update summary

Study background and objectives

• The SOLARIS phase III trial evaluated a new subcutaneous long-acting injectable (LAI) formulation of Olanzapine (TEV-749) for adults with acute schizophrenia exacerbation, aiming to address relapse rates and adherence challenges.

• The study sought to eliminate the risk of Post-Injection Delirium/Sedation Syndrome (PDSS) seen with previous Olanzapine LAIs.

• The program included both acute and long-term safety and efficacy assessments, with an 8-week acute phase and up to 48 weeks of long-term follow-up.

• Doses tested were 318 mg, 425 mg, and 531 mg monthly, comparable to daily oral doses of 10, 15, and 20 mg.

Key efficacy and safety results

• TEV-749 met primary and key secondary endpoints, showing significant improvement in PANSS total score versus placebo at week 8, with sustained symptom improvement across all doses.

• Onset of effect was observed as early as week 2-3, with improvements in CGI-S and PSP scores.

• Over 3,470 injections in the long-term phase and nearly 4,000 overall showed no suspected or confirmed PDSS events.

• The formulation demonstrated a slow, controlled release, minimizing exposure spikes and supporting safety.

• Weight gain averaged 5.6 kg over 48 weeks, stabilizing after week 32, and injection site reactions were mostly mild to moderate, with less than 1% discontinuation due to side effects.

Clinical and market implications

• The new LAI formulation is expected to fill a significant treatment gap for patients with severe schizophrenia and adherence issues.

• The ease of subcutaneous administration and lack of PDSS risk may drive rapid adoption among patients and clinicians.

• The product is positioned to complement existing LAIs, expanding options for patients not well-controlled on other therapies.

• Franchise peak sales expectation for LAI schizophrenia products is estimated at $1.5B–$2.0B.

• Early adoption is anticipated from patients already on oral Olanzapine and those inadequately managed on other LAIs.