Healthcare Industry News: sinusitis
News Release - October 23, 2006
BROVANA(TM) (Arformoterol Tartrate) Inhalation Solution Study Data Presented at American College of Chest Physicians Annual ConferenceBROVANA Recently Approved by U.S. Food & Drug Administration for the Long-Term Maintenance Treatment of Bronchoconstriction With COPD
MARLBOROUGH, Mass.--(HSMN NewsFeed)--Sepracor Inc. (Nasdaq: SEPR ) today announced that it presented data from a Phase III pivotal trial of BROVANA(TM) (arformoterol tartrate) Inhalation Solution at CHEST 2006, the annual meeting of the American College of Chest Physicians (ACCP), in Salt Lake City.
Efficacy and Safety of Nebulized Arformoterol in COPD: A Prospective Phase III Clinical Trial
Results of a double-blind, randomized, placebo-controlled multi-center Phase III study that included 739 adult patients with chronic obstructive pulmonary disease (COPD) were presented. The study evaluated airway function improvement with BROVANA and salmeterol (SEREVENT®) metered-dose inhaler compared with placebo over a period of 12 weeks in patients with COPD.
"In this study, treatment with nebulized BROVANA resulted in rapid bronchodilation and maintenance improvement, providing beneficial therapeutic effects for patients with COPD," said William J. Calhoun M.D., Sealy and Smith Distinguished Professor of Internal Medicine; Director, Division of Allergy, Pulmonary, Immunology, CCM, and Sleep at the University of Texas Medical Branch, Galveston, Texas. "We've successfully used nebulizers for many patients with pulmonary diseases for years, and I'm excited that BROVANA received FDA approval, making it the first nebulized long-acting bronchodilator for use in COPD."
Patients treated with BROVANA demonstrated clinically meaningful and statistically significant improvement in morning trough FEV1 throughout the 12-week study period versus patients administered placebo. Morning trough FEV1 refers to the measure of forced expiratory volume in one second, obtained just prior to the morning dose. At Week 0, representing the first day of treatment, patients treated with BROVANA 15 mcg demonstrated mean percent improvement in morning trough FEV1 change from baseline of 21.8% versus 6.3% for those administered placebo (p<0.001). At Week 12, patients treated with BROVANA 15 mcg showed a mean percent improvement in morning trough FEV1 change from baseline of 14% versus 4.7% for those administered placebo (p=0.003).
In the study, the percentage of patients in the BROVANA 15 mcg treatment group who achieved improvement in FEV1 that was greater than or equal to 10% from predose was 88.3% versus 55.1% for patients administered placebo, at Week 0. The median time to achieve this response was 3.3 minutes in the BROVANA 15 mcg group and 213.7 minutes for those administered placebo. At Week 12, 84.3% of patients administered BROVANA 15 mcg demonstrated a 10% or greater increase in FEV1 while 40.7% of patients in the placebo group achieved a 10% or greater improvement in FEV1. At Week 12, the median time to achieve this response was 10.0 minutes for the BROVANA 15 mcg group and not applicable for the placebo treatment group, given that less than 50% of subjects responded. BROVANA was well tolerated in this study.
Approved by the U.S. Food and Drug Administration (FDA) on October 6, 2006, BROVANA is a long-term, twice-daily (morning and evening), maintenance treatment of bronchoconstriction in patients with 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 machine that converts liquid medication into a fine mist that is inhaled through a mouthpiece or mask.
Sepracor is targeting completion of launch preparations and introduction of BROVANA during the second quarter of 2007. Upon launch, Sepracor's sales force will promote BROVANA in hospitals and to primary care physicians and pulmonologists who treat patients with COPD.
According to the National Center for Health Statistics, COPD is the fourth leading cause of death in the U.S., and in 2004, approximately 12 million adults in the U.S. were reported to have COPD. 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. According to the NHLBI, COPD includes chronic bronchitis, chronic obstructive bronchitis and emphysema, or combinations of these conditions.
BROVANA has not been demonstrated to have an impact on the progression of disease or the survival of patients with COPD.
Important Safety Information
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 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.
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 are located in Marlborough, Massachusetts.
Forward Looking Statement
This news release contains forward-looking statements that involve risks and uncertainties, including statements with respect to safety, efficacy and potential benefits of BROVANA, and the expected commercial launch of BROVANA. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are: Sepracor's ability to fund further clinical trials; results of further clinical trials; Sepracor's ability to timely complete preparations for commercial launch of BROVANA and successfully commercialize BROVANA; continued growth of the COPD market; the scope of Sepracor's patents and the patents of others; Sepracor's ability to attract and retain qualified sales personnel and other employees; and certain other factors that are detailed in the company's quarterly report on Form 10-Q for the quarter ended June 30, 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.
Brovana is a trademark of Sepracor Inc. Serevent is a registered trademark of Glaxo Group Limited Corporation. For a copy of this release or any recent release, visit Sepracor's web site at www.sepracor.com.
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