In a Phase III clinical trial cariprazine met its primary endpoint demonstrating statistically significant change from baseline to week six in the Montgomery-Asberg Depression Rating Scale (MADRS) total score in patients with major depressive disorder, Richter said.
Richter's U.S. peer AbbVie, with whom it has a licensing agreement for cariprazine, plans to submit a supplemental new drug application to the US Food and Drug Administration for the expanded use of cariprazine for the adjunctive treatment of major depressive disorder, it added.
"We are proud that a second Phase III clinical study showed statistically significant and clinically relevant improvement for a large group of patients not adequately responding to existing treatment," CEO Gábor Orbán said.
"These results get us one step closer to a potential new adjunctive treatment option for major depressive disorder," he added.
"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," AbbVie vice chairman and president Michael Severino said.
"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," he added.
Cariprazine, marketed under the brand names Vraylar and Reagila, is used to treat depressive, acute manic, and mixed episodes associated with bipolar I disorder, as well as schizophrenia in adults. It is now Richter's second best-selling product after oral contraceptives.
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