FDA Extends Review of Resubmitted Atypical Antipsychotic

The FDA has extended its review of Richter and Allergan’s atypical antipsychotic, cariprazine, for the treatment of schizophrenia and manic or mixed episodes associated with bipolar disorder.

A recent response to a question from the FDA about cariprazine’s resubmitted New Drug Application (NDA) is a “major amendment” that requires a 3-month extension to September 2015, the agency said. Richter and Allergan formerly expected the FDA to decide on the NDA in the second quarter of this year.

"We continue to work with the FDA during their review of the cariprazine NDA,” stated David Nicholson, executive vice president of global R&D at Allergan, “The unmet need of patients suffering with bipolar disorder and schizophrenia continue to be of paramount importance to Allergan and Richter. We remain committed to pursuing this important treatment option for patients and physicians.”

The safety and efficacy of cariprazine was evaluated in a study of more than 2700 patients. The investigational atypical antipsychotic also showed promise in preventing relapse among schizophrenia patients in a phase 3 trial.

Cariprazine has been shown to increase the risk of akathisia and extrapyramidal disorder, but it has not been linked to weight gain, metabolic abnormalities, or prolactin increase.