Monday, October 09, 2006

FDA Approves Sepracor, Inc. BROVANA Inhalation Solution For Chronic Obstructive Pulmonary Disease

MARLBOROUGH, Mass.--Sepracor Inc. today announced that the U.S. Food and Drug Administration (FDA) approved its New Drug Application (NDA) for BROVANA(TM) (arformoterol tartrate) Inhalation Solution 15 mcg (micrograms) as a long-term, twice-daily (morning and evening), maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. BROVANA is for use by nebulization [see below] only.

BROVANA is the first long-acting beta2-agonist [Beta adrenoceptor type 2] to be approved as an inhalation solution for use with a nebulizer, which is a machine that converts liquid medication into a fine mist that is inhaled through a mouthpiece or mask.

"COPD mortality rates have been increasing and are expected to continue to rise," said William Bailey, M.D., Professor of Medicine, University of Alabama and Chairman, U.S. COPD Coalition, an organization comprised of 42 government, professional and patient groups dedicated to improving the lives of patients with COPD. "There are millions of Americans living with COPD(a) who may benefit from this new treatment option."

WHAT ARE beta2 receptors? These types of drugs, Beta2 agonists, work by bronchodilation. The open up the tubes in the lungs for easier breathing. They have a long duration of activity up to 3-4 hours. The most known, although not used very much anymore, is ephedrine, which was once used as an asthma treatment. Beta receptors regulate many functions in the body and are very large drug targets.

Sepracor is publicly traded on (Nasdaq: SEPR) is up 76 cents this morning to 50.96 in active trading.

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