Phase 3 Study Update of Cariprazine for Acute Mania in Bipolar I Disorder

Forest Laboratories and Gedeon Richter Plc announced preliminary results from a Phase 3 trial of cariprazine (RGH-188) in patients with acute mania associated with bipolar I disorder. For the primary endpoint, the Young Mania Rating Scale (YMRS), the data showed that cariprazine treated patients with acute manic episodes experienced significant improvements in symptoms compared to placebo-treated patients observed as early as Day 5 of treatment and at each subsequent time-point studied. The results of this study were consistent with the results observed in the two previously completed pivotal placebo-controlled cariprazine studies in this patient population.

This multicenter, double-blind, placebo-controlled, parallel-group study evaluated the efficacy, safety, and tolerability of cariprazine monotherapy in patients with acute mania associated with bipolar I disorder. During the five-week study, 497 men and women between 18–65 years of age meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder were randomized into three treatment groups and received at least one dose of either cariprazine 3–6mg/day (n=167), cariprazine 6–12mg/day (n=169) or placebo (n=161). Following a wash-out screening period of 4–7 days, patients received treatment for up to three weeks, which was followed by a two-week period of safety assessments. Patients were hospitalized throughout screening and for at least the first 14 days following initiation of treatment.

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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