Forest Laboratories Submits NDA for Cariprazine

Forest Laboratories,

and Gedeon Richter Plc. announced that Forest has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for cariprazine, a potent dopamine D3/D2 receptor partial agonist with preferential binding to D3 receptors. Cariprazine was discovered by Gedeon Richter Plc and is licensed to Forest Laboratories Inc., in the U.S. and Canada. The application for the treatment of schizophrenia includes results from three positive trials in over 1700 patients, two fixed dose studies with active controls and one fixed-flexible placebo-controlled dose study using the change from baseline in Positive and Negative Syndrome Scale (PANSS) total score as primary efficacy endpoint.