Allergan Hopes To Add Bipolar Depression To Vraylar's Label

18 Dec 2017

With Phase III success in bipolar depression, Allergan plans an sNDA in 2018 to add that indication to the atypical antipsychotic's label, which includes schizophrenia and bipolar mixed or manic episodes.

Positive Phase III data for atypical antipsychotic Vraylar (cariprazine) in depression associated with bipolar I disorder would appear to position the Allergan PLC drug for a supplemental new drug application (sNDA) filing in 2018, but the specialty pharma still doesn't know why the US FDA refused to file an sNDA for negative symptoms of schizophrenia in September.

Allergan announced on Dec. 18 that the drug, which is developed and commercialized in partnership with Gedeon Richter PLC, met the primary endpoint of improvement from baseline to week...

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