Allergan, Gedeon Richter Unbowed By Cariprazine MDD Phase III Trial Failure
Allergan and Gedeon Richter have hit a buffer in the development of their antipsychotic cariprazine in the additional indication of major depressive disorder, but they plan to proceed with a further pivotal trial, and mollified analysts with the announcement of a filing timeline to bolster the drug's label in schizophrenia.
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After recording its third positive pivotal trial in bipolar depression, Allergan will now file an sNDA for Vraylar in the second half of 2018.
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.
Gedeon Richter has finally had its antipsychotic cariprazine approved in the EU for treating schizophrenia - but its delay to market could dampen demand for the drug unless it can differentiate itself from rivals.