Formoterol study results
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>>Sepracor's (R,R)-Formoterol Phase IIA Study Complete
Study Demonstrates Immediate FEV1 Improvement and 24-Hour Duration
MARLBOROUGH, Mass., April 27 /PRNewswire/ -- Sepracor Inc. (Nasdaq: SEPR - news) today announced the results of a Phase IIA, 49-patient single-dose study comparing four doses of (R,R)-formoterol with the marketed dose of Ventolin® and placebo. This randomized, double-blind, placebo-controlled six-way cross- over study was designed to evaluate the duration and onset of improvement in forced expiratory volume in one second (FEV1), as well as the beta-agonist effects at the doses tested. The mean baseline FEV1 of patients tested was 60% of the predicted value. The four doses of (R,R)-formoterol studied were 12, 24, 48 and 72 mcg. The marketed dose of Ventolin is 2.5 mg. Patients abstained from using concomitant medications prior to testing.
(R,R)-Formoterol demonstrated an immediate increase in FEV1 after administration at all doses tested, with comparable peak FEV1 improvement. After 24 hours, patients receiving higher doses of (R,R)-formoterol showed improvements in FEV1 greater than 15%, and these improvements were greater than those exhibited by patients on Ventolin or placebo, (p <.05). Beta- mediated side effects of patients on doses of (R,R)-formoterol were equivalent to or less than those of patients on Ventolin. These side effects include pulse rate and blood glucose increases, and tremor.
(R,R)-Formoterol is a single-isomer form of Novartis' Foradil® and Yamanouchi's Atock®. The worldwide market for long-acting bronchodilators was approximately $1 billion in 1998.
''This study demonstrates the potential for (R,R)-formoterol to become the first bronchodilator to combine a rapid onset of FEV1 increase with clinically relevant lung function improvement for a full 24 hours,'' said Paul D. Rubin, M.D., Executive Vice President, Drug Development and ICE Research.
''We believe that a once-a-day prophylactic beta-agonist will provide a treatment option presently unavailable to patients with asthma and emphysema. The long-acting bronchodilator market is approximately $1 billion worldwide and rapidly growing,'' said Timothy J. Barberich, President and Chief Executive Officer.
''Based on these encouraging study results, we look forward to (R,R)- formoterol joining our growing portfolio of respiratory products,'' said David S. Barlow, President, Pharmaceuticals. ''Sepracor received U.S. Food and Drug Administration marketing approval last month for Xopenex(TM), its short-acting bronchodilator. Physicians are being
actively educated about Xopenex, which has been distributed to major drug wholesalers and chains.''
The Company plans to initiate larger dose-ranging trials in urgent and chronic care settings for (R,R)-formoterol in the second half of 1999.<< |
