BROVANA(TM) Inhalation Solution Now Available by Prescription for Patients with Chronic Obstructive Pulmonary Disease (COPD)
Apr 11, 2007 07:00:20 (ET)
MARLBOROUGH, Mass., Apr 11, 2007 (BUSINESS WIRE) -- Sepracor Inc. (SEPR, Trade ) today announced that BROVANA(TM) brand arformoterol tartrate Inhalation Solution is now available by prescription in pharmacies nationwide. BROVANA is 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 only.
BROVANA is the first long-acting bronchodilator to be approved as an inhalation solution for use with a nebulizer, which is a device that converts liquid medication into a fine mist that is inhaled through a mouthpiece or mask. Approximately 25 percent of patients with COPD in the U.S. currently use nebulizers(1).
"The launch of BROVANA expands our respiratory portfolio of products, which includes XOPENEX(R) Inhalation Solution and XOPENEX HFA(R) metered-dose inhaler, into the 13th largest prescription drug market in the U.S.(2)," said Adrian Adams, President and Chief Operating Officer of Sepracor Inc. "Sepracor's experienced respiratory sales force will promote BROVANA in hospitals and to primary care physicians and pulmonologists who treat patients with COPD. We are excited to offer this differentiated product to patients with COPD, and believe that BROVANA has significant potential as an answer to patient need for a long-acting beta-agonist inhalation solution."
Approximately 70 percent of patients with COPD have been diagnosed as having moderate, severe or very severe COPD(3). Long-acting bronchodilators are recommended for the long-term maintenance therapy of patients with COPD whose disease severity has progressed to moderate or higher.
"BROVANA is an important new treatment option for patients with COPD. Until now, many patients with COPD who use medications delivered via a nebulizer have had to depend on frequent dosing with short-acting bronchodilators to relieve their symptoms. However, the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines recommend the addition of long-acting bronchodilators for patients with moderate, severe or very severe COPD, when needed," said James Donohue, M.D., Professor of Medicine and Division Chief of Pulmonary Diseases and Critical Care Medicine, University of North Carolina, School of Medicine, Department of Medicine at Chapel Hill. "Availability of BROVANA provides the first-ever opportunity for physicians to prescribe a nebulized long-acting bronchodilator for maintenance therapy for patients who either require or prefer nebulizer therapy."
According to the National Center for Health Statistics, COPD is the fourth leading cause of death in the U.S. and it is estimated to be the third leading cause by the year 2020. Approximately 12 million adults in the U.S. are reported to have COPD, although approximately 24 million adults have evidence of impaired lung function, which may indicate that COPD is under-diagnosed, according to the National Heart, Lung, and Blood Institute (NHLBI). COPD is a slowly progressive disease of the airways that is characterized by a gradual loss of lung function and includes chronic bronchitis, chronic obstructive bronchitis and emphysema, or combinations of these conditions. BROVANA has not demonstrated an impact on patient mortality or progression of disease.
Sepracor's sales force has marketed XOPENEX brand levalbuterol HCl Inhalation Solution, which is a short-acting beta-agonist indicated for the treatment or prevention of bronchospasm in patients six years of age and older with reversible obstructive airway disease, since 1999. In December 2005, Sepracor launched XOPENEX HFA brand levalbuterol tartrate Inhalation Aerosol, a hydrofluoroalkane (HFA) metered-dose inhaler (MDI), which is a portable, hand-held device consisting of a pressurized canister containing medication and a mouthpiece through which the medication is inhaled. Indicated for the treatment or prevention of bronchospasm in adults, adolescents and children four years of age and older with reversible obstructive airway disease, XOPENEX HFA complements the XOPENEX Inhalation Solution product line and provides patients with a portable means of administering XOPENEX.
Important Safety Information - BROVANA |
