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FDA Approves Schizophrenia Drug

Illustration of brain (NIDA)

(National Institute of Drug Abuse)

Sunovion Pharmaceuticals Inc. in Marlborough, Massachusetts says that the U.S. Food and Drug Administration (FDA) approved its drug Latuda (lurasidone HCl) for the treatment of schizophrenia. Latuda is an oral, once-daily antipsychotic in tablet form, offering a treatment for patients with schizophrenia. It is expected to be available in the U.S. during the first quarter of 2011.

According to Sunovion, the FDA reviewed data from more than 40 clinical trials involving some 2,700 Latuda-treated adult subjects. The drug’s efficacy for the treatment of schizophrenia was established in four, 6-week placebo-controlled clinical trials. In these studies, Latuda demonstrated significantly greater improvement versus placebo on the primary efficacy measures by study’s end. Five clinical trials contributed to understanding of the drug’s tolerability and safety profile.

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.

Related: Biotech, Pharma Companies Partner on Schizophrenia Research

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