FDA Approves INVEGA™ (paliperidone) For Long-Term Maintenance Treatment Of Schizophrenia

Data Demonstrated Significant Delay in Time to Symptom Relapse

(April 27, 2007) -- The U.S. Food and Drug Administration (FDA) today 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™.

INVEGA™ (paliperidone) Extended-Release Tablets is (now) approved for the acute and maintenance treatment of schizophrenia in the U.S.

Worldwide, it is estimated that one person in every 100 develops schizophrenia, one of the most serious types of mental illness. In the United States, there are currently 2,000,000 people with schizophrenia, with men and women affected equally. The disease is marked by positive symptoms (hallucinations and delusions) and negative symptoms (depression, blunted emotions and social withdrawal), as well by disorganized thinking.

INVEGA™ was approved in December 2006, and was the first new prescription treatment for schizophrenia to be approved by the FDA since 2003. The once-daily oral medication is specifically designed to deliver paliperidone – the active ingredient derived from risperidone – through the innovative OROS® extended-release technology, demonstrating powerful efficacy and a proven safety and tolerability profile. INVEGA™ was discovered and jointly developed by Janssen, ALZA Corporation and Johnson & Johnson Pharmaceutical Research and Development, LLC.

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Janssen, L.P., based in Titusville, NJ, is the only pharmaceutical company in the U.S. dedicated solely to mental health. The company currently markets prescription medications for the treatment of schizophrenia, bipolar mania, and irritability associated with autistic disorder. For more information about Janssen, L.P., visit www.janssen.com; for more information on INVEGA™, visit www.INVEGA.com. 

*** A treatment-emergent adverse event is defined as any event not present before the initiation of the treatments or any event already present that worsens in intensity or frequency following exposure to the treatments.

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Source: Johnson&Jonson

Last updated: 04/07

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