Allergan’s supplemental new drug application (sNDA) for Vraylar (cariprazine) to treat negative symptoms associated with schizophrenia in adult patients has received a Refusal to File (RTF) letter from the US Food and Drug Administration (FDA).
Schizophrenia is a chronic and disabling disorder that leads to positive symptoms, including hallucinations, delusions and thought disorders, and negative symptoms, such as loss of motivation and social withdrawal.
The symptoms are significantly related to long-term morbidity, poor psychosocial functioning and high social and economic costs.
Vraylar an oral, once-daily atypical antipsychotic approved in the US for the treatment of patients with schizophrenia or the acute treatment of adult patients with manic or mixed episodes associated with bipolar I disorder.
After conducting preliminary review for the Allergan therapy, the US agency determined that the sNDA for treatment of negative symptoms was not sufficiently complete to grant a substantive review.
Allergan chief research and development officer Dr David Nicholson said: “We are disappointed with the FDA decision on our submission. We will request a meeting with FDA to discuss and determine our next steps.
“Vraylar is an important treatment option for patients suffering from bipolar I disorder and schizophrenia.
“We remain committed to our mental health programme and to cariprazine and its potential as a treatment option for patients suffering from negative symptoms associated with schizophrenia.”
Discovered and co-developed by Hungarian pharmaceutical company Gedeon Richter, Vraylar is currently licensed to Allergan in the US and Canada.