Phase III results add to case for Vraylar in bipolar depression

4 April 2018

Ireland-headquartered Allergan (NYSE: AGN) and Budapest-based Gedeon Richter (RICHT: HB) have announced positive top-line results for RGH-MD-53, a Phase III comparison of Vraylar (cariprazine) to placebo in adults with major depressive episodes associated with bipolar I depression.

RGH-MD-53 is the third of three positive pivotal trials of Vraylar in this indication and in this instance has yielded statistically-significant results only at the weaker 1.5mg dosage, with the stronger dose bringing an improvement versus placebo but failing to reach significance.

In December of last year, the companies announced positive top-line results for RGH-MD-54, the second pivotal trial of Vraylar in the treatment of bipolar I depression. In that study, both 1.5mg and 3mg were statistically greater than placebo.

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