Results From A Phase II Study Of Cariprazine For The Treatment Of Bipolar Depression

Forest Laboratories, Inc. And Gedeon Richter Plc Announce Results From A Phase II Study Of Cariprazine For The Treatment Of Bipolar Depression

Forest Laboratories, Inc. (NYSE: FRX) and Gedeon Richter Plc. today announced preliminary top-line results from an 8-week Phase II clinical trial of the novel, investigational antipsychotic agent cariprazine for the treatment of bipolar depression. Cariprazine is currently undergoing Phase III trials for separate indications of schizophrenia and bipolar mania.

A total of 233 patients were randomized to enter one of two active (low dose or high dose) treatment arms or placebo. The primary endpoint was the Montgomery Asberg Depression Rating Scale (MADRS) score. The study was designed to be exploratory. Although the overall difference observed between the drug-treated and placebo-treated groups was not statistically significant, over the course of the trial there was evidence of a clinically relevant treatment effect in the high-dose arm of the study by comparison to placebo. In addition, the tolerability results for cariprazine support further investigation in this patient population. Approximately 9% of patients discontinued the study early due to adverse events in the high dose study arm compared to 3% in the placebo arm. The companies are considering conducting an additional Phase II dose-response trial examining a wider range of doses.

About the Study

This was a randomized double-blind, placebo-controlled, flexible-dose group study that evaluated the efficacy, safety and tolerability of once-daily dosed cariprazine in patients with bipolar depression. Following a washout period of no antipsychotic therapy for at least one week, a total of 233 patients, all from U.S. clinical sites, between ages 18 and 65 years old were randomized to one of three treatment arms (either 0.25 – 0.75 mg per day of cariprazine or 1.5 – 3.0 mg per day of cariprazine) or placebo. The primary endpoint was defined as a change from baseline to Week 8 in the MADRS total score compared to placebo treatment.

About Cariprazine

Cariprazine, discovered by researchers at Gedeon Richter, is an orally active, potent D3/D2 partial agonist that preferentially binds to D3 receptors. In addition, cariprazine has a relatively low potency at other receptor sites, such as 5-HT2C, histamine H1, muscarinic and adrenergic receptor sites, which have been associated with adverse events. Cariprazine demonstrated a reduction in symptoms in previously reported Phase II clinical trials for schizophrenia and bipolar mania.

Source:
Gedeon Richter Plc.
Forest Laboratories