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The Supplemental New Drug Application was based on the results of numerous clinical trials.
AbbVie has officially submitted a Supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for cariprazine (VRAYLAR) as an adjunctive treatment for major depressive disorder (MDD).
The potential indication would be specifically for patients who are receiving ongoing antidepressant therapy.
The application was based on the results of several clinical trials, including the phase 3 Study 311-301-001, RGH-MD-75, and RGH-MD-76.
In 311-301-001, the treatment resulted in a clinically and statistically significant change in the Montgomery-Asberg Depression Rating Scale (MADRS) toral score from baseline to week 6 in patients treated with cariprazine 1.5 mg daily compared to placebo.
In the RGH-MD-75 registration enabling study, cariprazine also showed a clinically and statistically significant change in MADRS total score from baseline to week 8 in patients treated with cariprazine 2-4.5 mg per day compared to placebo.
Finally, the RGH-MD-76 study also examined the long-term safety and tolerability of the drug over 26 weeks.
The studies show a safety profile consistent with the safety profile of cariprazine for other indications, including for the treatment of adults with depressive, acute manic, and mixed episodes associated with bipolar I disorder and schizophrenia.
"Many people living with major depressive disorder struggle to find a treatment that reduces their depressive symptoms, with many taking years to find the right treatment,” Michael Severino, MD, vice chairman and president, AbbVie, said in a statement. “Cariprazine, when added to ongoing antidepressant treatment in patients with major depressive disorder, demonstrated that it can reduce depressive symptoms.”