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Studies Show Success with Cariprazine as Adjunctive Treatment of Major Depressive Disorder
AbbVie announced positive results from a Phase 3 study in which cariprazine (VRAYLAR) met the primary endpoint as an adjunctive treatment of major depressive disorder.
Cariprazine is US Food and Drug Administration (FDA)-approved to treat depressive, acute manic, and mixed episodes in bipolar I disorder, in addition to adult schizophrenia.
According to a news release, AbbVie “announced top-line results from two Phase 3 clinical trials, Study 3111-301-001 and Study 3111-302-001, evaluating the efficacy and safety of cariprazine (VRAYLAR®) as an adjunctive treatment for patients with major depressive disorder (MDD).”
In both studies, patients received with 1.5 mg a day cariprazine or 3.0 mg a day cariprazine, which were compared with placebo.
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In the first Phase 3 study, a statistically significant change on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline to 6 weeks was observed in patients taking cariprazine when compared with placebo.
In the second phase 3 study, patients taking cariprazine showed improvement in depressive symptoms on the MADRS when compared with placebo but did not meet its primary endpoint for either dose.
Safety results in all studies using cariprazine were consistent with the established safety profile.
"Major depressive disorder is one of the most common and serious mental illnesses, and more than half of these patients never experience satisfactory results from this debilitating condition. Based on the results, we believe cariprazine has the potential to benefit these patients as an adjunctive treatment,” said Michael Severino, MD, vice chairman and president, AbbVie.
Based on these results, AbbVie will submit a supplemental New Drug Application to the FDA for the use of cariprazine as a adjunctive treatment for major depressive disorder.
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