FDA News

FDA Approves INVEGA For Long-Term Maintenance Treatment Of Schizophrenia

(April 29, 2007)--The FDA approved INVEGA (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, M.D., 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 hope that new treatment options, such as INVEGA, will help patients with schizophrenia cope with this debilitating disease."

This long-term study of INVEGA systematically examined patients over time, enrolling individuals with acute schizophrenia first into an eight-week initiation period of treatment with INVEGA (3 mg-15 mg flexibly dosed, with a 9 mg starting dose), followed by a further six-week stabilization phase, during which patients remained on their previous dose. These stabilized patients were then observed for recurrence of symptoms of schizophrenia in a randomized, double blind, placebo-controlled phase until they relapsed, discontinued or completed the trial (ranging from six to 331 days). This double-blind phase studied 207 patients (105 randomly assigned to INVEGA and 102 randomly assigned to placebo), 75 of whom experienced a recurrence (23 on INVEGA and 52 on placebo).

INVEGA™ was seen to be significantly more effective than placebo in helping schizophrenia patients maintain control of their symptoms, and in delaying the time to relapse of symptoms. The final analysis of the study showed that 48.5 percent in the placebo group were able to proceed without a recurrence of symptoms, while 77.9 percent of patients in the INVEGA group progressed without relapse of symptoms.

There were three treatment-emergent adverse events (TEAEs) during the double blind, controlled phase of the study that occurred at a rate greater than or equal to five percent in either treatment group. These TEAEs were psychosis (23 percent placebo, seven percent INVEGA), insomnia (six percent placebo, five percent INVEGA), and aggressive reaction (six percent placebo, one percent INVEGA). Adverse events related to extrapyramidal symptoms (e.g., involuntary movements, tremors and rigidity) were seen in seven percent of INVEGA-treated patients compared with three percent in the placebo group during the double-blind phase. The incidence of TEAEs leading to discontinuation during the double-blind phase of this longer-term trial was one percent for placebo and three percent for INVEGA.

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