FDA Rejects Schizophrenia Drug Cariprazine
Agency requests more trial data (November 21)
The FDA has rejected a new drug application (NDA) for cariprazine (Forest Laboratories/Gedeon Richter), 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 its complete response letter, the FDA acknowledged that cariprazine demonstrated effectiveness in the treatment of schizophrenia and mania associated with bipolar disorder. However, the agency indicated that more information, including additional clinical trial data, is needed.
The safety and efficacy of cariprazine were studied in a clinical trial program involving more than 2,700 patients.
Schizophrenia affects more than 2 million people in the U.S., and bipolar disorder, which encompasses bipolar I and bipolar II disorders, affects approximately 5.7 million. Bipolar I disorder is also known as manic-depressive disorder.
Source: Forest Laboratories; November 21, 2013.