Teva presents new phase 3 efficacy, safety and tolerability data from solaris trial evaluating tev-‘749 (olanzapine) as a once-monthly subcutaneous long-acting injectable for adult patients diagnosed with schizophrenia
Tel aviv, israel & parsippany, n.j., sept. 21, 2024 (globe newswire) -- teva pharmaceuticals, a u.s. affiliate of teva pharmaceutical industries ltd. (nyse and tase: teva), today announced new positive efficacy, safety and tolerability results for phase 3 subcutaneous olanzapine extended-release injection study (solaris) trial evaluating tev-‘749 in adult patients diagnosed with schizophrenia. in the study, tev-‘749 met the primary endpoint, demonstrating significant improvements in the positive and negative syndrome scale (panss) total score from baseline to week 8, as well as key secondary endpoints with improvements in both the clinical global impression-severity (cgi-s) scale and the personal and social performance (psp) scale score, compared to placebo at week 8. additionally, solaris (period 1) and phase 1 safety results demonstrated no incidence of post-injection delirium/sedation syndrome (pdss) in participants taking tev-‘749 to date.1 the overall safety profile was consistent with other oral acting olanzapine options. these data were presented during the 37th annual european college of neuropsychopharmacology (ecnp) congress taking place between september 21-24, 2024, in milan, italy.
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