Forest Laboratories has submitted a New Drug Application in the USA for the antipsychotic cariprazine.
Cariprazine, which was discovered by Hungary's Gedeon Richter and licensed to Forest in the USA and Canada, has been filed for the treatment of both schizophrenia and manic or mixed episodes associated with bipolar I disorder. The drug is a dopamine D3/D2 receptor partial agonist with preferential binding to D3 receptors.
The schizophrenia application includes results from three positive trials in over 1,700 patients and the manic episodes submission is backed by another three successful studies involving more than 1,000 patients. In all the studies, cariprazine was well tolerated and the most commonly-reported adverse reactions, which were predominantly mild to moderate in severity, were akathisia, extrapyramidal disorder, dyspepsia, restlessness, tremor, fatigue and vomiting.
Forest is hoping that cariprazine will help soften the financial blow of losing patent protection on its flagship product Lexapro (escitalopram), an antidepressant licensed from Denmark’s Lundbeck.