Study Confirms Takeda And Sunovion's Lurasidone Long-Term Efficacy

Takeda Pharmaceutical International GmbH and Sunovion Pharmaceuticals, Inc. announced positive study results confirming long term efficacy of lurasidone for maintenance treatment of adults with schizophrenia.

Lurasidone is a once-daily oral atypical antipsychotic and was evaluated for efficacy, tolerability, and safety in a double-blind, placebo-controlled, randomized withdrawal study. Participating adult patients who were stabilized on lurasidone at a flexible dosage of 40-80 mg/day during open-label treatment were randomized to either maintain treatment with lurasidone or placebo for up to 28 weeks. Primary endpoint for the study was to measure time to relapse over 28 weeks of the double-blind phase. Results showed that patients who continued treatment with lurasidone experienced significant delay in time to relapse in comparison with those who received placebo. Patients who received maintenance treatment with lurasidone were also associated with a 33.7% reduction in risk of relapse compared to patients who took placebo.

Rajiv Tandon, Vice Chair and Professor of Psychiatry at the University of Florida College of Medicine, Chief of Psychiatry at the North Florida/South Georgia Veterans Health System in Florida, and lead author on the study, said, “Schizophrenia is a chronic condition that is severe and disabling, so it is important that healthcare providers not only address the acute symptoms of the illness, but also minimize the risk of experiencing relapse, a common challenge with the disorder. This study supports the efficacy of lurasidone in preventing relapse while producing few changes in weight, lipids and measures of glycemic control.”

The company submitted the results to the European Medicines Agency (EMA) for possible inclusion in the Summary of Product Characteristics. The Committee for Medicinal Products for Human Use (CHMP) of the EMA has earlier issued its positive opinion for lurasidone last January for the treatment of schizophrenia in adult patients.

Antony Loebel, M.D., Executive Vice President and Chief Medical Officer at Sunovion Pharmaceuticals Inc., said, “Lurasidone has demonstrated efficacy and safety in a number of short-term studies of adults with schizophrenia. We are pleased to see the results of this study confirm the long-term efficacy of lurasidone in schizophrenia. In addition, long-term effects on metabolic parameters were consistent with the findings of short-term studies.”

The drug is currently available under the brand name Latuda in the U.S., Canada, and Switzerland.