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FDA Approves INVEGA(R) SUSTENNA(TM) for the Acute and Maintenance Treatment of Schizophrenia
Date:7/31/2009

TITUSVILLE, N.J., July 31 /PRNewswire/ -- The U.S. Food and Drug Administration today approved INVEGA(R) SUSTENNA(TM) (paliperidone palmitate) extended-release injectable suspension for the acute and maintenance treatment of schizophrenia in adults. It is the first once-monthly, long-acting, injectable atypical antipsychotic approved in the U.S. for this use. Janssen(R), Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc, will market INVEGA SUSTENNA in the U.S.

An estimated one percent of the world's population suffers from schizophrenia - a brain disorder that impairs a person's ability to think clearly, relate to others, and distinguish between reality and imagination. While there is no cure for schizophrenia, the symptoms and the risk of relapse (an exacerbation of symptoms) can be managed in most patients with appropriate treatment that includes continuous, long-term therapy with antipsychotic medications.(1)

Unfortunately, 80 percent of patients with schizophrenia experience at least one relapse within five years of diagnosis(2), and the risk for relapse in patients can substantially increase as a result of non-adherence.(2) Research shows that many patients treated with an oral atypical antipsychotic miss taking medication for about one-third of the year (110 days).(3) Therefore, it is critical for healthcare professionals to ensure that patients are following their treatment plans in order to help reduce the risk of relapse, because prognosis and outcome can progressively decline with each successive relapse.(4)

"Inconsistent compliance with medications is arguably one of the single greatest impediments to managing the symptoms of schizophrenia and delaying the time to relapse," said Henry A. Nasrallah, M.D., a clinical investigator who worked on the INVEGA SUSTENNA clinical trials, and a Professor of Psychiatry and Neuroscience and Director of the Schizophren
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SOURCE Janssen
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