Long-Term Effectiveness With Subcutaneous Long-Acting Injectable Olanzapine (TV-44749) in Adults With Schizophrenia: Results From up to 48 Weeks Open Label Treatment in the Phase 3 SOLARIS Trial
Long-acting injectable (LAI) antipsychotics improve adherence and outcomes in adults with schizophrenia. Olanzapine is available as an intramuscular LAI; however, post-injection delirium/sedation syndrome (PDSS) risk and the associated Risk Evaluation and Mitigation Strategy (REMS) limits its use. TV-44749, an investigational once-monthly, subcutaneous LAI, utilizes an innovative copolymer delivery technology that ensures extended release of olanzapine, designed to eliminate risk of PDSS. SOLARIS (NCT05693935) was a phase 3 trial assessing efficacy, safety, and tolerability of TV-44749 in adults (18–64 years) with schizophrenia.
SOLARIS comprised an 8-week, randomized, double-blind, placebo-controlled period (Period 1 [P1]) followed by an open-label safety period ≤48 weeks (Period 2 [P2]). In P2 (n=423), P1 TV-44749 participants retained their treatment, and those previously assigned placebo were rerandomized 1:1:1 to TV-44749 (318mg, 425mg, or 531mg). Here we present results through the end of treatment (EoT; 4 weeks after the P2 last dose).
TV-44749 met all primary and key secondary (type-I error controlled) endpoints during P1. TV-44749 exhibited long-term symptom improvement and maintained clinical effectiveness, with results from all TV-44749 doses demonstrating stable change from P2 baseline through EoT in Positive and Negative Syndrome Scale (PANSS) total and Clinical Global Impression-Severity (CGI-S) scale scores (mean change from baseline: -7.2 and -0.5, respectively). TV-44749 also improved patient functioning, with a 4.6-point mean increase in Personal and Social Performance Scale (PSP) score from P2 baseline. Improvements were also observed in participants receiving ≥10 TV-44749 injections in P2. No suspected or confirmed PDSS events were reported in 3470 injections throughout the trial.
