COLORADO SPRINGS, Colo., March 30, 2007 /PRNewswire/ -- Longer-term treatment with INVEGA(TM) (paliperidone) Extended-Release Tablets, a new once daily oral medication for schizophrenia, helped many patients effectively control their symptoms and maintain their improvements in personal and social functioning.
These latest data are from a large, open label, international clinical trial sponsored by Janssen, L.P., the U.S. marketer of INVEGA, and were presented today at the International Congress on Schizophrenia Research (ICOSR). INVEGA was approved last December by the U.S. Food and Drug Administration for the treatment of schizophrenia.
"Schizophrenia imposes serious, lifelong psychological, physical, social, and economic burdens on patients, caregivers and heath care systems worldwide," said Herb Meltzer, MD, Bixler/May/Johnson Professor of Psychiatry & Pharmacology at the Vanderbilt University School of Medicine. "I am encouraged by the results of this pooled analysis because of the need for antipsychotic treatment options that provide effective symptom control, good tolerability, and which help to sustain the ability of patients to function over the long term."
In a pre-planned analysis, researchers evaluated data from 1,083 patients at 168 centers across North America, Europe, Asia, South Africa, and 12 other countries in the open-label extension (OLE) of three similarly designed six- week double-blind studies. In the 52-week OLE phase of the studies, the patients maintained effective symptom control and the improvement in personal and social performance achieved during the six-week double-blind phase.
These studies provided longer-term follow-up to the three
previously completed six-week, placebo-controlled trials that
demonstrated efficacy and