Monthly Olanzapine Extended-Release Injectable Suspension (TV-44749) for Subcutaneous Use Leads to Early, Consistent Symptom Improvements Through Week 8 in Adults With Acute Exacerbation of Schizophrenia: Phase 3 SOLARIS Trial

TV-44749 is once-monthly, subcutaneous, extended-release injectable based on innovative copolymer delivery technology that ensures controlled release of olanzapine, designed to provide sustained efficacy over 1 month without post-injection delirium/sedation syndrome (PDSS) risk. SOLARIS (NCT05693935), a randomized, double-blind, placebo-controlled phase 3 study, assessed the efficacy, safety, and tolerability of TV-44749. 675 adult patients with acute exacerbation of schizophrenia were randomized 1:1:1:1 to once-monthly TV-44749 (318mg, 425mg, or 531mg) or placebo.

In the 8-week acute treatment phase (Period 1) of SOLARIS, TV-44749 met its primary endpoint, change in Positive and Negative Syndrome Scale (PANSS) total score from baseline to week 8 versus placebo (all doses P < 0.0001). Analysis of secondary efficacy endpoints showed early and persistent changes across clinician and patient-rated global illness scales. For PANSS total score, statistical significance versus placebo was met at week 2 for 318mg and 425mg and week 3 for 531mg (P < 0.05). For change in Clinical Global Impression-Severity scale score, statistically significant change versus placebo was achieved at week 2 for 425mg, week 3 for 318mg, and week 4 for 531mg (P < 0.05). All TV-44749 doses demonstrated superior change in CGI-Improvement scale score at week 4 versus placebo (P < 0.0001). For change in Patient Global Impression of Improvement scale score, statistically significant improvement versus placebo was achieved at week 2 for 318mg and 425mg, and week 4 for all doses (P < 0.05). For all TV-44749 doses, statistical superiority compared with placebo was maintained through week 8 across all respective scales. As of 08/2024 (3217 active injections), no PDSS events were reported.