Healthcare Industry News: sinusitis
News Release - April 11, 2007
BROVANA(TM) Inhalation Solution Now Available by Prescription for Patients with Chronic Obstructive Pulmonary Disease (COPD)MARLBOROUGH, Mass.--(HSMN NewsFeed)--Sepracor Inc. (Nasdaq: SEPR ) 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® Inhalation Solution and XOPENEX HFA® 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
Long-acting beta2-adrenergic agonists may increase the risk of asthma-related death. Data from a large placebo-controlled U.S. study that compared the safety of another long-acting beta2-adrenergic agonist (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol may apply to arformoterol (a long-acting beta2-adrenergic agonist), the active ingredient in BROVANA.
Data are not available to determine whether the rate of death in patients with COPD is increased by long-acting beta2-adrenergic agonists. BROVANA is indicated for the long-term, twice-daily (morning and evening) maintenance treatment of bronchoconstriction in chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. BROVANA is for use by nebulization only. BROVANA is not indicated for the treatment of acute episodes of bronchospasm, i.e. rescue therapy. BROVANA should not be initiated in patients with acutely deteriorating COPD, which may be a life-threatening condition.
BROVANA should not be used in conjunction with other inhaled, long-acting beta2-agonists. BROVANA should not be used with other medications containing long-acting beta2-agonists. As with other inhaled beta2-agonists, BROVANA can produce paradoxical bronchospasm that may be life threatening. If paradoxical bronchospasm occurs, BROVANA should be discontinued immediately and alternative therapy instituted. BROVANA, like other beta2-agonists, can produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, blood pressure, and/or symptoms. Although such effects are uncommon after administration of BROVANA at the recommended dose, if they occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce ECG changes, such as flattening of the T wave, prolongation of the QTC interval and ST segment depression. The clinical significance of these findings is unknown. BROVANA, as with other sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias and hypertension; in patients with convulsive disorders or thyrotoxicosis; and in patients who are unusually responsive to sympathomimetic amines.
In clinical studies, the numbers and percent of patients who reported adverse events were comparable in the BROVANA 15 mcg twice daily and placebo groups. The most frequent adverse events reported in patients taking BROVANA that were greater than the frequency reported in patients taking placebo were pain (8%), chest pain (7%), back pain (6%), diarrhea (6%) and sinusitis (5%). BROVANA, as with other long-acting beta2-adrenergic agonists, should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or drugs known to prolong the QTC interval because these agents may potentiate the action of adrenergic agonists on the cardiovascular system.
Important Safety Information - XOPENEX
XOPENEX HFA Inhalation Aerosol and XOPENEX Inhalation Solution are contraindicated in patients with a history of hypersensitivity to levalbuterol, racemic albuterol or any other component of XOPENEX HFA Inhalation Aerosol or XOPENEX Inhalation Solution. XOPENEX HFA Inhalation Aerosol and XOPENEX Inhalation Solution and other beta-agonists can produce paradoxical bronchospasm, which may be life threatening. If additional adrenergic drugs, including other short-acting sympathomimetic bronchodilators or epinephrine, are to be administered by any route, they should be used with caution to avoid deleterious cardiovascular effects. Due to the cardiovascular side effects associated with beta-agonists, caution is generally recommended for patients with cardiovascular disorders (especially coronary insufficiency, cardiac arrhythmias and hypertension), diabetes, hyperthyroidism, or convulsive disorders. Also, see the complete prescribing information regarding potential drug interactions with beta-blockers, diuretics, digoxin or MAOI and tricyclic antidepressants.
Sepracor Inc. is a research-based pharmaceutical company dedicated to treating and preventing human disease by discovering, developing and commercializing innovative pharmaceutical products that are directed toward serving unmet medical needs. Sepracor's drug development program has yielded a portfolio of pharmaceutical products and candidates with a focus on respiratory and central nervous system disorders. Sepracor's corporate headquarters is located in Marlborough, Massachusetts.
This news release contains forward-looking statements that involve risks and uncertainties, including statements with respect to the expected commercial launch of BROVANA brand arformoterol tartrate Inhalation Solution and the safety, efficacy, potential benefits, possible uses and commercial success of BROVANA, XOPENEX brand levalbuterol HCl Inhalation Solution and XOPENEX HFA brand levalbuterol tartrate Inhalation Aerosol. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are: unexpected delays in commercial introduction of BROVANA; the scope of Sepracor's patents and the patents of others and the success of challenges by others of Sepracor's patents; the outcome of litigation and regulatory decisions relating to Sepracor's patents, products and product candidates; the clinical benefits of BROVANA, XOPENEX Inhalation Solution and XOPENEX HFA Inhalation Aerosol; changes in the use and/or label of BROVANA or Sepracor's other products; the ability of the company to attract and retain qualified personnel; and certain other factors that may affect future operating results and are detailed in the company's annual report on Form 10-K for the year ended December 31, 2006 filed with the Securities and Exchange Commission.
In addition, the statements in this press release represent Sepracor's expectations and beliefs as of the date of this press release. Sepracor anticipates that subsequent events and developments may cause these expectations and beliefs to change. However, while Sepracor may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Sepracor's expectations or beliefs as of any date subsequent to the date of this press release.
(1) IMS estimates 25% of COPD patients as nebulized solution users (2.9MM patients).
(2) Source: IMS NPA 2006, total prescriptions for short-acting beta-agonist and long-acting beta-agonist markets, excluding ADVAIR®; all channels. Data do not include all hospital and Medicare Part B transactions.
(3) Percentages from Datamonitor DMHC2147, 2005. Pipeline Insight: Asthma/COPD. Reference code: DMHC2251. November 2006.
Brovana is a trademark and Xopenex and Xopenex HFA are registered trademarks of Sepracor Inc. Advair is a registered trademark of Glaxo Group Limited.
For a copy of this release or any recent release, visit Sepracor's web site at www.sepracor.com.
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