FDA Approves INVEGA (TM) for Long-Term Maintenance Treatment of Schizophrenia.

Data Demonstrated Significant Delay in Time to Symptom Relapse

TITUSVILLE, N.J., April 27 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) today approved INVEGA(TM) (paliperidone) Extended-Release Tablets, a new once-daily, atypical antipsychotic, for the long-term maintenance treatment of schizophrenia. INVEGA is now indicated for both acute (short-term) and maintenance (long-term) treatment of schizophrenia.

The agency's latest approval for INVEGA is based on a long-term efficacy study that demonstrated a significant benefit in delaying the time to relapse of symptoms of schizophrenia. This study ended early because efficacy was clearly demonstrated in a planned interim analysis. In addition, this study further supports the proven safety and tolerability profile seen in prior short-term studies. INVEGA is marketed in the U.S. by Janssen, L.P.

"Findings from this clinical trial complement the data supporting the use of INVEGA in the acute treatment of schizophrenia and suggest that efficacy can be maintained for many patients," said George M. Simpson, MD, Professor of Research, Director Outpatient Clinic, Keck School of Medicine of the University of Southern California, and one of the study's investigators. "Physicians now have a once-daily treatment option that can help many patients reduce symptom severity and also help stabilize patients with longer-term use."

Janssen President Janet Vergis said the approval is another example of Janssen's exclusive commitment to mental health. "It is our…