Forest Laboratories, Inc. (NYSE:FRX) and Gedeon Richter Plc. announced that the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding the New Drug Application (NDA) for cariprazine, an atypical antipsychotic for the treatment of schizophrenia and for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.
In the complete response letter, the FDA acknowledged that cariprazine clearly demonstrated effectiveness in the treatment of schizophrenia and mania associated with bipolar disorder. However, the Agency indicated more information, including additional clinical trial data, would be needed. “Given the complex pharmacokinetics and metabolism of cariprazine, we believe this request was made to better define the optimal dosing regimen to maintain the demonstrated efficacy, while minimizing the potential for the development of adverse events generally associated with this class of drug”, said Dr. Marco Taglietti, President, Forest Research Institute.
Dr. Taglietti further noted that “the unmet medical need for schizophrenia and bipolar disorder remains high. We are committed to pursuing novel treatment options like cariprazine to address patient needs. Forest and Gedeon Richter plan to meet with the FDA in the very near future to discuss the complete response letter and define a path forward.”
Cariprazine, an investigational drug, is an atypical antipsychotic for the treatment of patients with schizophrenia and for patients with manic or mixed episodes associated with bipolar I disorder. The safety and efficacy of cariprazine was studied in a clinical trial program of more than 2,700 patients. Cariprazine is protected by a composition-of-matter patent that expires in 2027 without patent term extension.
Schizophrenia is a chronic and disabling disorder that affects more than 2 million people in the U.S. 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).