Allergan, Richter prep for FDA OK with positive PhIII for cariprazine in bipolar depression
Allergan $AGN and its partner Gedeon Richter came out this morning with some affirming Phase III data of its drug cariprazine, setting the duo on track for an add-on FDA OK that could mean big money for the partners.
The drug, already approved under the brand name Vraylar for schizophrenia and manic episodes, was tested in patients with depressive episodes associated with bipolar 1 disorder. During the trial, called RGH-MD-53, 493 patients were given either a 1.5 mg dose of cariprazine, a 3 mg dose, or placebo. For the patients on the smaller dose, secondary and primary endpoints were met, showing a significantly greater improvement than placebo for the change from baseline to week 6 on both the primary efficacy parameter, the Montgomery-Asberg Depression Rating Scale (p=0.0417), and the key secondary parameter, Clinical Global Impression Scale-Severity (p=0.0417).
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