INVEGA May Help Patients With Schizophrenia Maintain Symptom Control
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 tolerability for INVEGA in the treatment of patients with schizophrenia. In this study, participants were treated with flexible doses of INVEGA (3mg to 15mg once daily, with 9mg as the starting dose) after concluding their previous double-blind study treatment. The study population was segmented into three subgroups based on treatment experience during the previous six-week trials: placebo to INVEGA; INVEGA to INVEGA; and olanzapine to INVEGA.
Because there were more INVEGA active treatment groups in the short-term efficacy trials, most patients entering this OLE study had previously received short-term treatment with INVEGA. Patient groups receiving INVEGA in the short-term efficacy trials were shown to have significantly improved by the end of short-term treatment when they became eligible to enter the OLE study, both in symptoms and in functioning, compared to placebo. In total, 47 percent of patients completed the longer-term 52-week OLE study.
Efficacy analyses included change from baseline to end point in Positive and Negative Syndrome Scale (PANSS)* total score and the Personal and Social Performance (PSP)** scale, a measure of personal and social functioning.