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Study Suggests INVEGA(TM) Helps Patients With Schizophrenia Maintain Symptom Control
52-Week Trial Maintained Improvement in Personal and Social Performance
COLORADO SPRINGS, Colo., March 30 /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."
Safety Analyses of Clinical Data for Bifeprunox in Patients With Schizophrenia Showed a Favorable Weight and Lipid Profile, Comparable With Placebo
MARIETTA, Ga., March 30 /PRNewswire/ -- Solvay Pharmaceuticals, Inc., Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE) , and Lundbeck A/S presented clinical study results on bifeprunox at an international medical congress this week. Safety analyses suggest bifeprunox, an investigational treatment for adult patients diagnosed with schizophrenia, was associated with a favorable weight and lipid profile, comparable with placebo. In addition, increases in weight occurred in patients receiving active references versus placebo.
The analyses presented this week are based on further evaluation of clinical studies presented last year, which illustrated that, in a six-month trial, bifeprunox maintained stability in patients with stable schizophrenia versus placebo. In six-week trials, bifeprunox improved symptoms in patients with acute exacerbations of schizophrenia but showed a smaller mean effect than did active references versus placebo.
"Data from Phase 2 and Phase 3 trials suggest that, if approved, bifeprunox may be an important treatment option for stable patients with schizophrenia -- particularly because of our concerns about the high prevalence of metabolic syndrome in this patient population," says Herbert Y. Meltzer, M.D., Professor of Psychiatry and Director of the Division of Psychopharmacology, Vanderbilt University Medical Center. "If approved, bifeprunox may be an important alternative for treating adult patients with schizophrenia over the long term."
SEROQUEL(R) Sustained Release Schizophrenia Data Presented at ECP Congress in Madrid
March 28, 2007 - 4:17 PM
LONDON, March 18 /PR Newswire/ -- AstraZeneca (NYSE:AZN) today announced SEROQUEL(R) sustained release formulation (quetiapine fumarate sustained release) clinical trial data presented at the European Congress of Psychiatry (ECP) in Madrid. The data demonstrated that the SEROQUEL(R) sustained release formulation (quetiapine fumarate sustained release), administered once daily, significantly improved symptoms associated with schizophrenia(1) (measured by PANSS) and increased the time to psychiatric relapse(2), when administered through a 3-step dose initiation aimed at reaching the effective dose range on the second day of treatment.
SEROQUEL(R) sustained release formulation is under review by regulatory authorities around the world for the treatment of schizophrenia and has not been approved in any market.
52-Week Trial Maintained Improvement in Personal and Social Performance
COLORADO SPRINGS, Colo., March 30 /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."
Safety Analyses of Clinical Data for Bifeprunox in Patients With Schizophrenia Showed a Favorable Weight and Lipid Profile, Comparable With Placebo
MARIETTA, Ga., March 30 /PRNewswire/ -- Solvay Pharmaceuticals, Inc., Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE) , and Lundbeck A/S presented clinical study results on bifeprunox at an international medical congress this week. Safety analyses suggest bifeprunox, an investigational treatment for adult patients diagnosed with schizophrenia, was associated with a favorable weight and lipid profile, comparable with placebo. In addition, increases in weight occurred in patients receiving active references versus placebo.
The analyses presented this week are based on further evaluation of clinical studies presented last year, which illustrated that, in a six-month trial, bifeprunox maintained stability in patients with stable schizophrenia versus placebo. In six-week trials, bifeprunox improved symptoms in patients with acute exacerbations of schizophrenia but showed a smaller mean effect than did active references versus placebo.
"Data from Phase 2 and Phase 3 trials suggest that, if approved, bifeprunox may be an important treatment option for stable patients with schizophrenia -- particularly because of our concerns about the high prevalence of metabolic syndrome in this patient population," says Herbert Y. Meltzer, M.D., Professor of Psychiatry and Director of the Division of Psychopharmacology, Vanderbilt University Medical Center. "If approved, bifeprunox may be an important alternative for treating adult patients with schizophrenia over the long term."
SEROQUEL(R) Sustained Release Schizophrenia Data Presented at ECP Congress in Madrid
March 28, 2007 - 4:17 PM
LONDON, March 18 /PR Newswire/ -- AstraZeneca (NYSE:AZN) today announced SEROQUEL(R) sustained release formulation (quetiapine fumarate sustained release) clinical trial data presented at the European Congress of Psychiatry (ECP) in Madrid. The data demonstrated that the SEROQUEL(R) sustained release formulation (quetiapine fumarate sustained release), administered once daily, significantly improved symptoms associated with schizophrenia(1) (measured by PANSS) and increased the time to psychiatric relapse(2), when administered through a 3-step dose initiation aimed at reaching the effective dose range on the second day of treatment.
SEROQUEL(R) sustained release formulation is under review by regulatory authorities around the world for the treatment of schizophrenia and has not been approved in any market.
