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Subcutaneous Olanzapine Long-Acting Injection Meets Efficacy Endpoint in Phase 3 Trial
An investigational, once-monthly, subcutaneous long-acting injection of olanzapine called TEV-‘749 met its primary endpoint in the efficacy portion of the phase 3 Subcutaneous OLAnzapine extended-Release Injection Study (SOLARIS), developers Teva Pharmaceuticals and Medincell recently announced.
The efficacy portion of the trial randomized 675 patients in a 1:1:1:1 ratio to receive low-, medium-, or high-dose TEV-‘749 or placebo. At 8 weeks, TEV-‘749 achieved its primary endpoint by demonstrating clinically meaningful and statistically significant reductions on Positive and Negative Syndrome Scale (PANSS) total scores across all dose groups compared with placebo, the companies reported. Between baseline and week 8, the mean difference in change on the PANSS total score with TEV-‘749 compared with placebo was -9.71 points in the high-dose group, -11.27 points in the medium-dose group, and -9.71 points in the low-dose group.
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TEV-‘749 was well-tolerated and, at the time of the announcement, no cases of post-injection delirium/sedation syndrome (PDSS) had been reported. Characterized by the sudden onset of delirium or sedation within the first hours of treatment, PDSS is a risk with long-acting olanzapine treatments currently on the market and has been associated with the intramuscular injection of long-acting olanzapine, according to the Teva and Medincell.
TEV-‘749 is a subcutaneous injection that uses a copolymer technology proprietary to Medincell to provide a controlled, steady release of olanzapine, the companies added.
“These data reinforce the potential of TEV-‘749 as a subcutaneous long-acting injectable by using a proven molecule with an established long-acting delivery system,” said Christoph Correll, MD, professor of psychiatry at the Zucker School of Medicine, Hempstead, New York, and SOLARIS coordinating investigator.
Additional efficacy and safety results from the study are planned for presentation at a medical conference later in 2024. In the meantime, the open-label portion of SOLARIS, which is scheduled to last up to 48 weeks, is following the long-term safety of TEV-‘749 as well as the incidence of PDSS.
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