Positive phase III efficacy results from SOLARIS trial evaluating TEV ‘749 (olanzapine) as a once-monthly subcutaneous long-acting injectable in adults with schizophrenia

Results demonstrated that TEV-‘749 met its primary endpoint as measured by a change in the PANSS total score from baseline after 8 weeks compared to placebo. TEV-‘749 utilizes SteadyTeq , a copolymer technology proprietary to Medincell that provides a controlled steady release of olanzapine, the most prescribed 2nd generation antipsychotic for schizophrenia in the U.S.

TEV-‘749 met its primary endpoint across all three dosing groups, with mean difference in change in the Positive and Negative Syndrome Scale (PANSS) total score from baseline to week 8 of -9.71 points, -11.27 points, and -9.71 points versus placebo for the high, medium, and low dose groups, respectively. These differences from placebo were clinically meaningful and statistically significant with adjusted P-values of <0.001 for each comparison. key secondary endpoints of cgi-s (clinical global impressions – schizophrenia) and psp (personal and social performance scale) total score were also statistically significant after adjusting for multiplicity. no cases of pdss have been reported to date, after administration of approximately 80% of the target injection number.>

The PANSS is composed of 3 subscales: Positive Scale, Negative Scale, and General Psychopathology Scale. Each subscale is rated with 1 to 7 points ranging from absent to extreme. Each of the 30 items is accompanied by a specific definition as well as detailed anchoring criteria for all seven rating points. These seven points represent increasing levels of psychopathology, as follows: 1- absent 2- minimal 3- mild 4- moderate 5- moderate severe 6- severe 7- extreme; the PANSS overall total score ranges from 30 to 210, with a higher score indicating greater symptom severity. The primary efficacy endpoint was measured by change from baseline to week 8 against the PANSS total score.

Additional efficacy and safety findings from the Phase III SOLARIS study are planned for presentation at a medical meeting later this year. The long-term safety of TEV-‘749 and incidence of PDSS are also being evaluated in the SOLARIS open-label study (period 2) with safety data topline readout expected in the second half of 2024.

T here is an open place on the market for an effective long-acting olanzapine treatment option. The only option of the sort, Lilly’s Zyprexa Relprevv, is linked with a risk of post-injection delirium/sedation syndrome (PDSS). The condition causes the sudden onset of delirium or sedation within hours of receiving treatment.