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Study Suggests Treatment with Paliperidone ER Significantly Improves Symptoms of Schizoaffective Disorder
Date:4/1/2009

and maintenance treatment of schizophrenia in the U.S. and for the treatment of schizophrenia in the E.U.

In February 2009, two supplemental new drug applications (sNDAs) were submitted to the FDA requesting approval for the use of paliperidone ER for the treatment of schizoaffective disorder as monotherapy and for use in combination with antidepressants and/or mood stabilizers. If approved by the FDA, INVEGA(R) would be the only medication indicated to treat the condition.

Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., is based in Titusville, N.J. and is the only large pharmaceutical company in the U.S. dedicated solely to mental health. It has prescription medications for the treatment of schizophrenia, bipolar mania and the treatment of symptoms associated with autistic disorder. For more information about Janssen, visit http://www.janssen.com.

Ortho-McNeil Janssen Scientific Affairs, LLC, and Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., are part of the Johnson & Johnson family of companies.

IMPORTANT SAFETY INFORMATION FOR INVEGA(R)

Elderly Patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. INVEGA(R) (paliperidone) is not approved for the treatment of patients with dementia-related psychosis.

Neuroleptic Malignant Syndrome (NMS) is a rare and potentially fatal side effect reported with INVEGA(R) and similar medicines. Call your doctor immediately if the person being treated develops symptoms such as high fever; stiff muscles; shaking; confusion; sweating; changes in pulse, heart rate, or blood pressure; or muscle pain and weakness. Treatment should be stopped if the person being treated has NMS.

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SOURCE Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD)
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