Forest Laboratories, Inc., (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 D
receptor partial agonist with preferential binding to D
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.
The application for the acute treatment of manic or mixed episodes associated with Bipolar I Disorder includes results from three positive placebo-controlled trials in over 1000 patients, two flexible dose studies and one fixed-flexible dose study using the change from baseline in the Young Mania Rating Scale (YMRS) total score as primary efficacy endpoint.
In the schizophrenia and bipolar mania pivotal trials, cariprazine was generally well tolerated. The most commonly reported adverse reactions (≥5% and twice placebo), which were predominantly mild to moderate in severity, were akathisia, extrapyramidal disorder, dyspepsia, restlessness, tremor, fatigue and vomiting.
Schizophrenia is a chronic and disabling disorder that affects more than 2 million American adults. It imposes significant burden on patients, their families, and society. Symptoms fall into three broad categories: positive symptoms (hallucinations, delusions, thought disorders, and movement disorders), negative symptoms (such as loss of motivation and social withdrawal), and cognitive symptoms (problems with executive functioning, focusing, and working memory).
About Bipolar I Disorder
Bipolar I disorder, also known as manic-depressive illness, is characterized by unusual shifts in mood, energy, activity levels, and the ability to carry out day-to-day tasks. It affects more than 5.7 million American adults. Patients experience "mood episodes" which manifest as either a manic episode (overexcited, extreme irritability, racing thoughts, and difficulties with sleep) or a depressive episode (extreme sadness, fatigue or hopelessness) or a combination of both.