Sunovion Pharmaceuticals Inc. Announces Data Published in the CHEST Journal from a One-year, Large Simple Safety Study Evaluating BROVANA® (arformoterol tartrate) Inhalation Solution *The study objective was met demonstrating that chronic obstructive pulmonary disease (COPD) patients treated with BROVANA are not at an increased risk of respiratory death or COPD exacerbation-related hospitalization compared to placebo. *BROVANA was well tolerated and improved lung function versus placebo in patients with COPD. Business Wire MARLBOROUGH, Mass. -- July 8, 2014 Sunovion Pharmaceuticals Inc. (Sunovion) today announced that data from a one-year, Large Simple Safety Study (LSSS) were published online in the CHEST Journal (e-publication ahead of print), the official publication of the American College of Chest Physicians. The objective of the study was to demonstrate that the risk of respiratory death or chronic obstructive pulmonary disease (COPD) exacerbation-related hospitalization for patients treated with BROVANA^® (arformoterol tartrate) Inhalation Solution was not greater than 40 percent more than the risk for patients treated with placebo. The trial objective was met demonstrating that COPD patients treated with BROVANA are not at an increased risk of respiratory death or COPD exacerbation-related hospitalizations compared to placebo. The complete study is available on the journal’s website: http://journal.publications.chestnet.org/article.aspx?articleid=1884678. “Approximately 15 million adults living in the country are currently diagnosed with COPD and many more who have the disease have not yet been diagnosed. In addition to burdens on the patient, COPD is associated with approximately $50 billion in costs, including those caused by hospitalizations,”^1,2 said James Donohue, M.D., lead investigator, and Professor of Medicine and the former Chief of Pulmonary Diseases and Critical Care Medicine at the University of North Carolina, School of Medicine. “This study supports BROVANA as a safe and effective treatment option for COPD patients.” BROVANA is a twice-daily nebulized long-acting beta agonist (LABA) approved by the U.S. Food and Drug Administration (FDA) for the long-term maintenance treatment of bronchoconstriction in patients with COPD, including chronic bronchitis and emphysema. The primary assessment of the study was time from randomization to respiratory death or first COPD exacerbation-related hospitalization, whichever occurred first. Among 841 subjects, 466 completed one year of treatment. Patients who discontinued treatment for any reason were followed for up to one year after randomization to assess for primary events. Fewer patients on BROVANA experienced a primary event (respiratory death or first COPD exacerbation-related hospitalization) compared to placebo (9.5% vs. 15.0%, respectively) as well as fewer COPD exacerbation-related hospitalizations (9.0% vs. 14.3%, respectively). Additionally, the risk for first respiratory serious adverse event was 50 percent lower with BROVANA than placebo. The study, which also measured efficacy, showed that BROVANA was associated with greater improvements in lung function, demonstrating significant improvements in placebo adjusted trough forced expiratory volume in one second (FEV) and trough forced vital capacity (FVC) from baseline. “The data from the Large Simple Safety Study reinforce the long-term safety and efficacy of BROVANA as a maintenance treatment for COPD and serve to demonstrate the impact of a long acting bronchodilator administered via nebulization,” said Alistair Wheeler, M.D., Vice President, Clinical Development and Medical Affairs at Sunovion. “As part of our commitment to respiratory care, these findings underscore our dedication to delivering impactful treatments for patients.” “Sunovion has a long history in providing therapies for patients suffering from respiratory disease,” said Richard Russell, Executive Vice President and Chief Commercial Officer at Sunovion. “This study represents the completion of our post-marketing commitment to the FDA. More importantly it adds to the growing body of evidence concerning the safety profile of BROVANA and reinforces it as an important and relevant option for appropriate patients with COPD. We are extremely proud of the results from this study.” About the BROVANA Large Simple Safety Study This multicenter, double-blind, randomized, placebo-controlled, parallel group, non-inferiority study enrolled 841 patients at least 40 years old with COPD and a baseline of ≤65 percent forced expiratory volume in one second (FEV1), a ≥15-pack-year smoking history and baseline breathlessness severity grade ≥2. Patients received BROVANA 15 mcg or placebo twice daily for one year, and were evaluated for the incidence of respiratory-related deaths and/or COPD exacerbation-related hospitalizations. The study participants were followed for up to one year after randomization to treatment; 466 subjects completed one year of treatment. Patients in both groups were also treated with their previous COPD medications, with the exception of LABAs [NCT00909779]. About BROVANA^®(arformoterol tartrate) Inhalation Solution BROVANA^®(arformoterol tartrate) Inhalation Solution is indicated for the 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. Important Safety Information for BROVANA^® WARNING: ASTHMA-RELATED DEATH Long-acting beta-adrenergic agonists (LABA) increase the risk of asthma-related death. Data from a large placebo-controlled US study that compared the safety of another long-acting beta-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 is considered a class effect of LABA, including arformoterol, the active ingredient in BROVANA (see WARNINGS). The safety and efficacy of BROVANA in patients with asthma have not been established. All LABA, including BROVANA, are contraindicated in patients with asthma without use of a long-term asthma control medication (see CONTRAINDICATIONS). BROVANA is not indicated for the treatment of acute episodes of bronchospasm, ie, rescue therapy, and does not replace fast-acting rescue inhalers. 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 beta-agonists. BROVANA should not be used with other medications containing long-acting beta-agonists. Patients who have been taking inhaled short-acting beta-agonists on a regular basis should be instructed to discontinue their regular use and to use them only for symptomatic relief for acute respiratory symptoms. All LABA, including BROVANA, are contraindicated in patients with asthma without use of a long-term asthma control medication. As with other inhaled beta-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 beta-agonists, can produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, blood pressure, and/or symptoms. BROVANA 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. BROVANA, as with other beta-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 the action of adrenergic agonists on the cardiovascular system may be potentiated by these agents. Overall efficacy of BROVANA was maintained throughout the 12-week trial duration. Some tolerance to the bronchodilator effect of BROVANA was observed after 6 weeks of dosing (at the end of the dosing interval), although the FEVimprovement remained statistically significant. This was not accompanied by other clinical manifestations of tolerance. The five most common adverse events reported with frequency ≥ 2% in patients taking BROVANA, and occurring more frequently than in patients taking placebo, were pain (8% vs 5%), chest pain (7% vs 6%), back pain (6% vs 2%), diarrhea (6% vs 4%), and sinusitis (5% vs 4%). For additional information, please see the full Prescribing Information and Medication Guide for BROVANA (arformoterol tartrate) Inhalation Solution at SunovionProfile.com/BROVANA. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088. About Sunovion Pharmaceuticals Inc. (Sunovion) Sunovion is a leading pharmaceutical company dedicated to discovering, developing and commercializing therapeutic products that advance the science of medicine in the Psychiatry & Neurology and Respiratory disease areas. Sunovion’s drug development program, together with its corporate development and licensing efforts, has yielded a portfolio of pharmaceutical products including Aptiom^®(eslicarbazepine acetate), Latuda^®(lurasidone HCl) tablets, Lunesta^®(eszopiclone) tablets, Xopenex^®(levalbuterol HCI) inhalation solution, Xopenex HFA^®(levalbuterol tartrate) inhalation aerosol, Brovana^®(arformoterol tartrate) inhalation solution, Omnaris^®(ciclesonide) nasal spray, Zetonna^®(ciclesonide) nasal aerosol and Alvesco^®(ciclesonide) inhalation aerosol. Sunovion, an indirect, wholly-owned U.S. subsidiary of Sumitomo Dainippon Pharma Co., Ltd., is headquartered in Marlborough, Mass. More information about Sunovion Pharmaceuticals Inc. is available at www.sunovion.com. About Sumitomo Dainippon Pharma Co., Ltd. Sumitomo Dainippon Pharma is a top-ten listed pharmaceutical company in Japan with a diverse portfolio of pharmaceutical, animal health and food and specialty products. Sumitomo Dainippon Pharma aims to produce innovative pharmaceutical products in the Psychiatry & Neurology area and the Oncology area, which have been designated as the focus therapeutic areas. Sumitomo Dainippon Pharma is based on the merger in 2005 between Dainippon Pharmaceutical Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has about 7,000 employees worldwide. Additional information about Sumitomo Dainippon Pharma is available through its corporate website at www.ds-pharma.com LATUDA ^ is a registered trademark of Sumitomo Dainippon Pharma Co., Ltd., Ltd. LUNESTA, XOPENEX, XOPENEX HFA, and BROVANA are registered trademarks of Sunovion Pharmaceuticals Inc. OMNARIS and ALVESCO are registered trademarks of Takeda GmbH, used under license. APTIOM is under license from BIAL. Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Sumitomo Dainippon Pharma Co., Ltd.^© 2014 Sunovion Pharmaceuticals Inc. For a copy of this release, visit Sunovion’s web site at www.sunovion.com ^1 http://www.cdc.gov/copd/ ^2 http://www.nhlbi.nih.gov/resources/docs/2009_ChartBook.pdf Contact: Sunovion Pharmaceuticals Inc. Patricia Moriarty, 508-787-4279 Senior Director, Corporate Communications email@example.com
Sunovion Pharmaceuticals Inc. Announces Data Published in the CHEST Journal from a One-year, Large Simple Safety Study
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