AbbVie announced it will present positive data from a Phase 3 trial of cariprazine (VRAYLAR®; 1.5mg/day), Study 3111-301-001, for the adjunctive treatment of major depressive disorder (MDD) in patients with an inadequate response to ongoing antidepressant therapy. The study met its primary endpoint of statistically significant improvement using the Montgomery-Åsberg Depression Rating Scale (MADRS) total score in patients compared with placebo. These results will be presented (Poster Number: P7-037) on May 24, 2022, at the American Psychiatric Association (APA) Annual Meeting in New Orleans.

AbbVie's supplemental New Drug Application (sNDA) for cariprazine was supported by two positive registration-enabling studies, of which one was Study 3111-301-001. The sNDA is currently under review by the U.S. Food and Drug Administration (FDA) for expanded use in the adjunctive treatment of MDD with a decision expected by year-end. The Phase 3 study showed a statistically significant change from baseline to week six in the MADRS total score for patients treated with cariprazine at 1.5 mg/day compared with placebo (p-value = 0.0050).

Patients treated with cariprazine at 3.0 mg/day demonstrated improvement in MADRS total score at week six compared to placebo but did not meet statistical significance (p-value=0.0727). In this study, the safety data was consistent with the established safety profile of cariprazine across indications. There were no deaths in the trial, with serious adverse events (SAE) occurring in both treatment (two SAEs) and placebo (two SAEs) groups.

The most common adverse events (AE) in the treatment group were akathisia and nausea (=5%). Cariprazine is marketed as VRAYLAR® in the United States and is FDA-approved to treat adults with depressive, acute manic and mixed episodes associated with bipolar I disorder, as well as schizophrenia. Cariprazine is being co-developed by AbbVie and Gedeon Richter Plc.

More than 8,000 patients worldwide have been treated with cariprazine across more than 20 clinical trials evaluating the efficacy and safety of cariprazine for a broad range of psychiatric disorders.