INVEGA(TM) Approved By FDA as New Treatment for Schizophrenia.

First Oral Extended Release Medication to Treat Schizophrenia

TITUSVILLE, N.J., Dec. 20 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved INVEGA(TM) (paliperidone) Extended-Release Tablets, a new atypical antipsychotic, for the treatment of schizophrenia. The once-daily oral medication is specifically designed to deliver paliperidone -- the active ingredient derived from risperidone -- through the innovative OROS(R) extended-release technology, demonstrating powerful efficacy and a proven safety and tolerability profile. INVEGA will be marketed by Janssen, L.P., based in Titusville, N.J. and will be available in the U.S. in January 2007.

"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," said Henry Nasrallah, M.D., 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 (PSP) Scale, which measures personal and social functioning. At the recommended dose of 6 mg per day, INVEGA had a tolerability profile that was similar to placebo."

Leading national mental health advocacy and patient organizations also recognize the importance of new treatments for schizophrenia.

"We are pleased that innovative delivery technologies are being applied to new treatments for schizophrenia," said Michael J. Fitzpatrick, MSW, Executive Director, National Alliance on Mental Illness (NAMI). "New and efficacious treatment options, like INVEGA, provide significant…