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GEN News Highlights : Dec 20, 2006

JJPRD Schizophrenia Therapy Given Go-Ahead

Treatment is intended as an oral extended release medication.

The FDA approved Johnson & Johnson Pharmaceutical Research & Development’s (JJPRD) treatment for schizophrenia. Janssen, L.P., a JJPRD subsidiary, will market Invega™, which it anticipates will be available in January 2007. The company reports that this approval marks the first new prescription in this field since 2003.

Invega extended-release tablets is a once-daily oral medication specifically designed to deliver paliperidone, the active ingredient derived from risperidone, through the Oros® extended-release technology. "A well-designed series of worldwide clinical trials involving more than 1,600 patients in 23 countries, have demonstrated that Invega provided significant improvement in multiple domains for the symptoms of schizophrenia," points out Henry Nasrallah, M.D., consultant for the company, professor of psychiatry and neuroscience, and director of the Schizophrenia Research Program at the University of Cincinnati Academic Health Center.

"In addition, in these clinical trials, Invega demonstrated not only efficacy in treating the symptoms of schizophrenia, but also improvement in the personal and social performance scale, which measures personal and social functioning."