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Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Announces FDA Filings for Paliperidone Palmitate and INVEGA(R)
Date:2/6/2009

TITUSVILLE, N.J., Feb. 6 /PRNewswire/ -- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) today announced that the company has submitted multiple applications to the U.S. Food and Drug Administration (FDA) which, if approved, would broaden treatment options for patients diagnosed with schizophrenia or schizoaffective disorder.

Earlier this week, the company submitted its response to the FDA complete response letter for paliperidone palmitate, received in August 2008. Paliperidone palmitate is an investigational once-monthly atypical antipsychotic injection which, if approved, will be indicated for the acute and maintenance treatment of schizophrenia.

The company also submitted two supplemental new drug applications (sNDAs) to the FDA requesting approval for the use of INVEGA tablets for the treatment of schizoaffective disorder as monotherapy and for use in combination with antidepressants and/or mood stabilizers. The sNDA submissions include data from two international, 6-week double-blind placebo-controlled studies that evaluated the efficacy and safety of INVEGA in patients with schizoaffective disorder. If approved by the FDA, INVEGA would be the only medication indicated to treat the condition.

Patients with schizoaffective disorder experience the psychotic symptoms of schizophrenia, such as hallucinations or delusions, as well as mania and/or depression. Because of the similarity in symptoms, schizoaffective disorder is sometimes misdiagnosed as schizophrenia or bipolar disorder. For patients who frequently use mental health services, schizophrenia and schizoaffective disorder may account for approximately 32% and 24% of cases respectively.(i)

INVEGA, an atypical antipsychotic medication, was first approved in the U.S. in December 2006 and is marketed by Janssen. It is approved for the acute and maintenance treatment of schizophrenia in the U.S. an
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SOURCE Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD)
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