Forest Laboratories Submits NDA for Cariprazine
Forest Laboratories, (NYSE: FRX) 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.