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INVEGA(R) Approved as the First and Only Treatment for Schizoaffective Disorder
Date:7/31/2009

TITUSVILLE, N.J., July 31 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) today approved the first and only antipsychotic for the acute treatment of schizoaffective disorder. INVEGA(R) (paliperidone) extended-release tablets were approved for the acute treatment of schizoaffective disorder either as monotherapy or adjunctive therapy to mood stabilizers and/or antidepressants. INVEGA(R) was approved in 2006 for the treatment of schizophrenia. Janssen(R), Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc, markets INVEGA(R) in the U.S.

Differentiating schizoaffective disorder from schizophrenia or a mood disorder can be difficult. Patients with schizoaffective disorder experience the psychosis characteristic of schizophrenia, such as hallucinations or delusions, as well as symptoms of mania and/or depression. Among people who frequently use mental health services, schizoaffective disorder may account for approximately 24 percent of cases.(1)

"Schizoaffective disorder can be challenging to diagnose because of the broad range of symptoms patients experience," said Nina Schooler, Ph.D.,* SUNY Downstate Medical Center. "The approval of INVEGA(R) is exciting as it is the only antipsychotic treatment proven in double-blind, randomized, placebo-controlled trials to be efficacious with a demonstrated tolerable safety profile treating both the psychotic and affective symptoms present in this understudied population."

The approval is based on two international, randomized, double-blind, placebo-controlled studies of patients with an established diagnosis of schizoaffective disorder, who were experiencing acute symptoms. In the first six-week study, patients received flexible doses of INVEGA(R) (3-12 mg once daily). In the other study, patients were assigned to one of two dose levels of INVEGA(R): 6 mg with the option to reduce to 3 mg, or 12 mg with the opt
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SOURCE Janssen
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