Marlborough, MA — Sunovion Pharmaceuticals Inc. (Sunovion) today announced that the U.S. Food and Drug Administration (FDA) has approved LATUDA (lurasidone HCl) tablets for the treatment of schizophrenia. LATUDA is an oral, once-daily atypical antipsychotic, offering a first-line treatment option for patients with schizophrenia and is expected to be available in the U.S. during the first quarter of 2011.
"LATUDA marks both a significant achievement for our company as well as the first FDA approval for Sunovion since becoming the U.S. subsidiary of Dainippon Sumitomo Pharma Co., Ltd.," said Masayo Tada, president and chief executive officer, Dainippon Sumitomo Pharma Co., Ltd. "With this approval, we've taken another big step towards becoming a truly competitive global company by enhancing the presence of Sunovion in the United States."
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.
"LATUDA offers a once-daily treatment option that has been shown to be both effective and tolerable, adding to psychiatrists' ability to address the challenging therapeutic needs of people with schizophrenia," said Antony Loebel, MD, executive vice president, Clinical Research and Medical Affairs at Sunovion Pharmaceuticals Inc.
The FDA reviewed data from more than 40 clinical trials involving approximately 2,700 LATUDA-treated adult subjects. The efficacy of LATUDA for the treatment of schizophrenia was established in four pivotal, six-week placebo-controlled clinical trials. In these studies, LATUDA demonstrated significantly greater improvement versus placebo on the primary efficacy measures [the Positive and Negative Syndrome Scale (PANSS) total score and the Brief Psychiatric Rating Scale-derived from PANSS (BPRSd)] at study endpoint. A total of five clinical trials contributed to the understanding of the tolerability and safety profile of LATUDA.
"Schizophrenia is associated with severe and debilitating symptoms such as delusions, hallucinations and disorganized thinking, and it can often have a devastating impact on patients and their families," said Herbert Meltzer, MD, professor of psychiatry and pharmacology, Vanderbilt University School of Medicine. "Based on the results of the clinical trials, LATUDA represents an important addition to the treatment of schizophrenia."