Forest Submits Schizophrenia Drug with FDA
Forest Laboratories has filed a New Drug Application (NDA) 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 submitted for the treatment of both schizophrenia and manic or mixed episodes connected to bipolar I disorder.
The antipsychotic is a dopamine D3/D2 receptor partial agonist with preferential binding to D3 receptors.
The schizophrenia NDA submission to the US regulators includes outcomes from three positive clinical trials in more than 1,700 patients. The manic episodes submission to the Food and Drug Administration (FDA) is supported by an additional three successful studies involving over 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, fatigue, dyspepsia, tremor, restlessness, extrapyramidal disorder and vomiting.
Zsuzsa Beke, Richter’s spokeswoman, noted that if the FDA approves the new drug, it could be launched in the US during the first half of 2014. “In Europe, the required tests are ongoing, the launch here could happen in around 2015-16,” Beke added.
She refused to provide any revenue or profit contribution approximation for Cariprazine but noted the American schizophrenia drug market is worth around $3 billion, while the total antipsychotic market is worth roughly $20 billion.
Forest is hoping that Cariprazine will help soften the financial knockback of losing patent protection on their flagship product Lexapro, an antidepressant licensed from Lundbeck.