NORTH CHICAGO, Ill. - Cariprazine has been found effective as an adjunctive treatment for patients with major depressive disorder, according to topline results were announced from two phase 3 trials.AbbVie today 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 the Study cariprazine showed a statistically significant change from baseline to week six in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score compared with placebo. Patients treated with cariprazine at 1.5 mg/day achieved improved MADRS total score at week six compared to placebo (p-value=0.0050). Patients treated with cariprazine at 3.0 mg/day demonstrated improvement in MADRS total score at week six over placebo but did not meet statistical significance (p-value=0.0727). In Study 3111-302-001, cariprazine demonstrated numerical improvement in depressive symptoms from baseline to week six in MADRS total score compared with placebo but did not meet its primary endpoint for either the 1.5 mg/day or 3.0 mg/day dose.
In a previously published Phase 2/3 registration-enabling study, RGH-MD-75, patients treated with cariprazine flexible doses of 2.0–4.5 mg/day in addition to ongoing antidepressant therapy (ADT) met the primary endpoint and achieved improved MADRS total scores at week eight compared to placebo (p-value=0.0114).
Based on the positive results of studies 3111-301-001 and RGH-MD-75, and the totality of data reported, AbbVie intends to submit a supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration for the expanded use of cariprazine for the adjunctive treatment of MDD.
"When added to ongoing antidepressant treatment that has produced inadequate response in patients with major depressive disorder, cariprazine has now demonstrated that it can further improve depressive symptoms by providing statistically significant and clinically meaningful improvements compared to placebo in two large, well-controlled registrational clinical trials," said Michael Severino, M.D., vice chairman and president, AbbVie. "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."
The safety results of cariprazine in all three studies were consistent with its established safety profile across indications with no new safety signals identified. The most common adverse events occurring at >5% in the cariprazine groups during the six-week study period were akathisia, nausea, insomnia, headache and somnolence.
MDD is a common condition with 19 million people of all ages affected in the United States.1 The World Health Organization lists depression as the third-leading cause of disability worldwide and as a major contributor to the overall global burden of disease.
Cariprazine is marketed as VRAYLAR in the United States and is FDA-approved to treat depressive, acute manic and mixed episodes associated with bipolar I disorder, as well as schizophrenia in adults. 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.