BioCentury
ARTICLE | Clinical News

Allergan's cariprazine meets again in Phase III for bipolar I depression

April 3, 2018 8:55 PM UTC

Allergan plc (NYSE:AGN) and Gedeon Richter plc (Budapest:RICHTER) said low-dose cariprazine met the primary endpoint in the Phase III RGH-MD-53 trial to treat bipolar I depression. Allergan reiterated its plan to submit an sNDA to FDA for the indication next half.

Cariprazine is already approved in the U.S. as Vraylar to treat schizophrenia and for the acute treatment of manic or mixed episodes associated with bipolar I disorder. The drug is approved in the EU as Reagila to treat schizophrenia...