FDA Approves Brovana Inhalation Solution for Chronic Obstructive Pulmonary Disease

FDA Approves Sepracor’s Brovana (Arformoterol Tartrate) Inhalation Solution for Chronic Obstructive Pulmonary Disease

MARLBOROUGH, Mass., October 7, 2006 -- Sepracor Inc. today announced that the U.S. Food and Drug Administration (FDA) approved its New Drug Application (NDA) for Brovana (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 only.

Brovana is the first long-acting beta2-agonist 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."

"We are very excited about the approval of Brovana," said Rudolf A. Baumgartner, M.D., Vice President, Respiratory and Immunology at Sepracor. "Brovana is the only FDA-approved, nebulized, long-acting beta2-agonist for patients with COPD, and we are looking forward to providing these patients with this new treatment option for managing their bronchoconstriction."

"The approval of Brovana adds another important treatment option to Sepracor’s respiratory franchise," said W. James O’Shea, President and Chief Operating Officer of Sepracor. "Upon launch, Sepracor’s sales force will promote Brovana in hospitals and to primary care physicians and pulmonologists who treat COPD patients. It remains our target to complete launch preparations and introduce Brovana during the second quarter of 2007."

Sepracor completed more than 100 preclinical and 16 clinical studies of Brovana, involving more than 2,000 patients. Among the clinical studies conducted were two 12-week pivotal studies, each with more than 700 patients, as well as an 800-patient, 12-month safety study. In Phase III studies, patients treated with Brovana demonstrated a statistically greater improvement in FEV1, a measure of lung function, than placebo. Brovana 15 mcg twice daily significantly improved bronchodilation compared to placebo over the 12 hours after dosing (FEV1 AUC0-12). This improvement was maintained over the 12-week study period. Following the first dose of Brovana 15 mcg, the median time to onset of bronchodilation, defined by an FEV1 increase of 15%, occurred at 6.7 minutes. When defined as an increase in FEV1 of 12% and 200 mL, the time to onset of bronchodilation was 20 minutes after dosing. Peak bronchodilator effect was generally seen within 1-3 hours of dosing.

"Patients who need a nebulized treatment may benefit from the rapid and sustained bronchodilation that Brovana, a long-term maintenance treatment, can provide," said James Donohue, M.D., Division Chief of Pulmonary Diseases and Critical Care Medicine, University of North Carolina at Chapel Hill. "Having Brovana as a choice in our COPD treatment arsenal offers us an effective and safe way to manage bronchoconstriction associated with this disease."

About 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 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.

Please refer to the product’s full prescribing information for additional information at: http://www.sepracor.com/BrovanaApprovedLabelingText.pdf.

(a) Summary Health Statistics for US Adults: National Health Interview Survey, 2004, Data from National Health Interview Survey (National Center for Health Statistics)

Source: Sepracor Inc.

Posted: October 2006


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