Positive data from phase III study of Vraylar for the adjunctive treatment of major depressive disorder.

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 Tuesday, May 24, 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 FDA for expanded use in the adjunctive treatment of MDD with a decision expected by year-end.

The Phase III 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%).

"The Phase III trial results, along with previous study results, indicate that cariprazine may have the potential to help patients with MDD for whom antidepressant therapy alone is not sufficient," said Gary Sachs, MD, associate clinical professor of psychiatry at Massachusetts General Hospital and lead author of the study. "Nearly half of patients with MDD do not experience satisfactory results from their current treatment regimen, so ongoing research to bring more options to patients is critical"