Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : Sepracor-Looks very promising -- Ignore unavailable to you. Want to Upgrade?

To: j_fir2 who wrote (2541)	4/27/1999 7:14:00 AM
From: BMcV	Read Replies (2) \| Respond to of 10280

Formoterol study results biz.yahoo.com >>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.<<