Poster
97
(#97) Long-Term Safety of Subcutaneous Long-Acting Injectable Olanzapine (TV-44749) in Schizophrenia: Results From the Phase 3 SOLARIS Trial
Psych Congress 2025
Abstract: TV-44749 is an innovative, subcutaneous long-acting injectable (LAI) olanzapine designed to provide sustained efficacy over the dosing interval without the post-injection delirium/sedation syndrome (PDSS) risk associated with LAI intramuscular olanzapine.
SOLARIS (NCT05693935) comprised an 8-week, randomized, double-blind, placebo-controlled period (Period 1 [P1]) in 18-64-year-old participants with schizophrenia, followed by an open-label, long-term safety period ≤48 weeks (P2). For P1, participants were randomized 1:1:1:1 to once-monthly TV-44749 (318mg, 425mg, 531mg) or placebo. For P2, P1 TV-44749 participants retained their treatment; P1 placebo participants were re-randomized to TV-44749 dose-groups. SOLARIS met all primary and key secondary efficacy (type-I error-controlled) endpoints. Safety endpoints for integrated trial periods-from first TV-44749 dose in P1 or P2 (≤56 weeks)-are presented.
Overall, 604 participants (318mg, n=204; 425mg, n=203; 531mg, n=197) from integrated trial periods were analyzed. Across TV-44749 groups, ≥1 treatment-emergent adverse event (TEAE) was reported in 449 (74%) participants; 50 (8%) had ≥1 TEAE leading to trial discontinuation. Serious AEs were reported in 36 (6%) participants. Three deaths occurred; none were treatment-related.
Most commonly reported TEAEs were weight increased (36%); injection site reactions (ISRs; induration [12%], pain [12%], erythema [10%], pruritus [7%]); and somnolence (7%). Most ISRs were mild/moderate; rates declined with subsequent injections. There were no new systemic safety signals compared with olanzapine's known safety profile. No suspected or confirmed PDSS events were reported in 3470 injections.
TV-44749 shows a long-term safety profile consistent with second-generation antipsychotic class effects and other olanzapine formulations, offering an effective LAI olanzapine that alleviates PDSS risk.
Short Description: In an analysis of long-term safety during the double-blind and open-label periods of the SOLARIS phase 3 trial of TV-44749 in adults with schizophrenia (n=604; 3470 total injections), there were no new systemic safety signals compared with olanzapine's known safety profile. No post-injection delirium/sedation syndrome (PDSS) events (suspected or confirmed) were reported. Results support the potential for TV-44749 to become the first LAI olanzapine to alleviate the risk of PDSS.
Name of Sponsoring Organization(s): Teva Branded Pharmaceutical Products R&D LLC
SOLARIS (NCT05693935) comprised an 8-week, randomized, double-blind, placebo-controlled period (Period 1 [P1]) in 18-64-year-old participants with schizophrenia, followed by an open-label, long-term safety period ≤48 weeks (P2). For P1, participants were randomized 1:1:1:1 to once-monthly TV-44749 (318mg, 425mg, 531mg) or placebo. For P2, P1 TV-44749 participants retained their treatment; P1 placebo participants were re-randomized to TV-44749 dose-groups. SOLARIS met all primary and key secondary efficacy (type-I error-controlled) endpoints. Safety endpoints for integrated trial periods-from first TV-44749 dose in P1 or P2 (≤56 weeks)-are presented.
Overall, 604 participants (318mg, n=204; 425mg, n=203; 531mg, n=197) from integrated trial periods were analyzed. Across TV-44749 groups, ≥1 treatment-emergent adverse event (TEAE) was reported in 449 (74%) participants; 50 (8%) had ≥1 TEAE leading to trial discontinuation. Serious AEs were reported in 36 (6%) participants. Three deaths occurred; none were treatment-related.
Most commonly reported TEAEs were weight increased (36%); injection site reactions (ISRs; induration [12%], pain [12%], erythema [10%], pruritus [7%]); and somnolence (7%). Most ISRs were mild/moderate; rates declined with subsequent injections. There were no new systemic safety signals compared with olanzapine's known safety profile. No suspected or confirmed PDSS events were reported in 3470 injections.
TV-44749 shows a long-term safety profile consistent with second-generation antipsychotic class effects and other olanzapine formulations, offering an effective LAI olanzapine that alleviates PDSS risk.
Short Description: In an analysis of long-term safety during the double-blind and open-label periods of the SOLARIS phase 3 trial of TV-44749 in adults with schizophrenia (n=604; 3470 total injections), there were no new systemic safety signals compared with olanzapine's known safety profile. No post-injection delirium/sedation syndrome (PDSS) events (suspected or confirmed) were reported. Results support the potential for TV-44749 to become the first LAI olanzapine to alleviate the risk of PDSS.
Name of Sponsoring Organization(s): Teva Branded Pharmaceutical Products R&D LLC
