Sunovion reports results of Latuda third phase 3 worldwide clinical trial for schizophrenia

Sunovion Pharmaceuticals Inc. (Sunovion) today announced the results of the PEARL 3 study, the third phase 3 worldwide clinical trial of Latuda^® (lurasidone HCl) tablets, a once-daily atypical antipsychotic agent recently approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with schizophrenia. In this six-week, placebo-controlled trial, both fixed doses of LATUDA 80 and 160 mg once-daily, demonstrated statistically significant improvement in symptoms of schizophrenia versus placebo across both primary and secondary efficacy measures. LATUDA was also well tolerated with a relatively low discontinuation rate. The LATUDA 160 mg/day dose has not been reviewed or approved by FDA. The study was presented today at the American College of Neuropsychopharmacology (ACNP) 49^th Annual Meeting in Miami, Florida.

“In this study once-daily LATUDA was given in the evening with food. This regimen was well-tolerated at the doses studied.”

"The recent FDA approval of LATUDA provides an additional treatment option for patients with schizophrenia. The PEARL 3 study data demonstrating clear efficacy coupled with weight and metabolic properties similar to placebo add to our understanding of the future role of LATUDA in managing the debilitating symptoms that can be challenging to treat," said Steven G. Potkin, M.D., professor, department of psychiatry and human behavior, University of California, Irvine and presenting author of the study.

The PEARL 3 study (Program to Evaluate the Antipsychotic Response to Lurasidone) was part of an extensive worldwide clinical development program involving more than 2,900 subjects, which evaluated the safety and efficacy of LATUDA for the treatment of adult patients with schizophrenia.

Schizophrenia is a chronic, disabling and serious brain disorder that affects approximately 2.4 million American adults or 1 in 100 people. Schizophrenia is characterized by symptoms such as hallucinations, delusions, disorganized thinking, lack of emotion, lack of energy, as well as problems with memory, attention and the ability to plan, organize and make decisions.