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INVEGA(TM) Significantly Reduced Symptoms of Schizophrenia Compared to SEROQUEL(R) in Acutely Ill, Hospitalized Patients
Date:10/13/2007

ORLANDO, Fla., Oct. 13 /PRNewswire/ -- Acutely ill, hospitalized patients with schizophrenia showed significant improvement in symptoms after taking INVEGA(TM) (paliperidone) Extended-Release Tablets as compared to SEROQUEL(R)(a) (quetiapine) and placebo. Symptom improvement was observed with INVEGA as early as five days into therapy and continued through the end of the two-week study period, according to preliminary data presented today at the 20th Annual U.S. Psychiatric and Mental Health Congress in Orlando, Florida (1).

The primary endpoint was the change in the total Positive and Negative Syndrome Scale (PANSS)(b) score over the first two weeks of the study. The results showed that INVEGA achieved a significant reduction of symptoms of acutely ill, hospitalized patients, compared to SEROQUEL and placebo after two weeks of treatment (p < less than > 0.001).

"In the treatment of patients with an acute exacerbation of schizophrenia, it is important to explore medications that have the potential to achieve effective, acute symptom control. Schizophrenia patients may take two to four weeks to respond fully to treatment, so the fact that noticeable clinical improvement was observed as early as day 5 in these acutely ill patients is very important," said Miranda Chakos, M.D. Professor of Psychiatry, State University of New York at Downstate, Brooklyn, N.Y., and one of the investigators of the trial. "INVEGA is an important treatment option for patients diagnosed with schizophrenia. This trial showed beneficial effects of INVEGA in severely ill, hospitalized patients with an acute exacerbation of schizophrenia."

In the study, 399 patients with an acute exacerbation of symptoms of schizophrenia were randomized to receive INVEGA, SEROQUEL or placebo. These patients were either hospitalized or in need of hospitalization at the start of the trial and willing to remain hospitalized for a minimum of 10 days. The study involved two phases: a two-week
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SOURCE Janssen, L.P. and Johnson & Johnson
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