FDA requests more data on Forest’s schizophrenia drug

The US Food and Drug Administraton (FDA) has issued a complete response letter to New York-based Forest Laboratories and Hungary's Gedeon Richter Plc regarding the New Drug Application (NDA) for their antipsychotic drug, cariprazine.

The NDA was submitted for cariprazine as 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.

While the FDA acknowledged that the drug clearly demonstrated effectiveness in the treatment of schizophrenia and mania associated with bipolar disorder, it indicated that more information, including additional clinical trial data, would be needed before an approval.

"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.

"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."

Dr. Marco Taglietti, President, Forest Research Institute.

Schizophrenia is a chronic and disabling disorder that imposes a 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).

Over 2 million people in the US, and approximately 24 million people worldwide, are affected by schizophrenia. According to the World Health Organisation (WHO), more than 50% of patients with schizophrenia are not receiving appropriate care.