April 3, 2018 / 12:24 PM / 20 days ago

BRIEF-Allergan And Richter Say Bipolar I Depression Study Meets Main Goal

April 3 (Reuters) - Allergan Plc - For Rgh-Md :

* ALLERGAN AND RICHTER ANNOUNCE POSITIVE TOPLINE RESULTS FROM THIRD OF THREE PIVOTAL TRIALS OF CARIPRAZINE IN BIPOLAR I DEPRESSION

* PRIMARY ENDPOINT WAS MET IN STUDY EVALUATING PATIENTS WITH ACUTE BIPOLAR I DEPRESSION TREATED WITH CARIPRAZINE 1.5 MG VERSUS PLACEBO

* CARIPRAZINE WAS GENERALLY WELL TOLERATED IN TRIAL

* PLANS TO INCLUDE DATA FROM ALL THREE PIVOTAL TRIALS IN CO’S SNDA TO U.S. FDA IN SECOND HALF OF 2018

* MOST COMMONLY REPORTED ADVERSE EVENTS IN CARIPRAZINE GROUPS WERE AKATHISIA, RESTLESSNESS, NAUSEA, AND FATIGUE

* EFFICACY OF CARIPRAZINE IN TREATMENT OF BIPOLAR I DEPRESSION HAS BEEN DEMONSTRATED IN THREE POSITIVE PIVOTAL TRIALS

* 53, PRIMARY AND KEY SECONDARY EFFICACY ENDPOINTS WERE MET FOR CARIPRAZINE 1.5 MG DOSE GROUP Source text for Eikon: Further company coverage:

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