Gedeon Richter And Actavis Announce Positive Late Stage Results For Cariprazine

(RTTNews) - Gedeon Richter Plc. and Actavis plc (ACT) announced positive results from a Phase III trial evaluating the efficacy and safety of cariprazine in the prevention of relapse in patients with schizophrenia.

There were 101 patients randomized to cariprazine 3 to 9 mg per day and 99 randomized to placebo. The primary efficacy measure was time to first relapse during the double-blind period. There were 25 relapses (24.8%) in the cariprazine group versus 47 relapses (47.5%) in the placebo group. Treatment with cariprazine was associated with a 55% reduction in risk of relapse versus placebo (hazard ratio 0.45, 95% CI [0.28, 0.73] p=0.0010).

Schizophrenia is a chronic and disabling disorder that affects more than 2 million people in the U.S. Symptoms fall into three broad categories: positive symptoms (hallucinations, delusions, thought disorders, and movement disorders), negative symptoms (such as loss of motivation and social withdrawal), and cognitive symptoms (problems with executive functioning, focusing, and working memory).

Cariprazine, an investigational drug, is a potent dopamine D3/D2 receptor partial agonist atypical antipsychotic with preferential binding to D3 receptors for the treatment of patients with schizophrenia and for adult patients with manic or mixed episodes associated with bipolar I disorder. Cariprazine is protected by a composition-of-matter patent that expires in 2027.