Phase 3 Study of Cariprazine for Acute Mania in Bipolar I Disorder
Forest Laboratories and Geodon Richter PIc announced results from its Phase 3 study of cariprazine (RGH-188) for the treatment of patients with acute mania associated with bipolar I disorder. This randomized, multicenter, double-blind, placebo-controlled, parallel-group study evaluated the efficacy, safety, and tolerability of cariprazine monotherapy in 312 patients, 18–65 years of age with acute mania associated with bipolar I disorder as determined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria.
For the primary endpoint, the Young Mania Rating Scale (YMRS), the data showed that cariprazine-treated patients with acute manic episodes experienced significant symptom improvement compared to placebo-treated patients (-19.6 cariprazine vs. -15.3 placebo, P<0.001) seen as early as Day 4 of treatment and at each subsequent time point studied.
Cariprazine (RGH-188) is an investigational, orally active, potent dopamine D3-preferring D3/D2 receptor partial agonist. In addition, cariprazine has a low potency at other receptor sites, such as 5-HT2C, histamine H1, muscarinic, and adrenergic receptor sites, which have been associated with adverse events.
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