MARLBOROUGH, Mass.--(BUSINESS WIRE)--Sunovion Pharmaceuticals Inc. (Sunovion) today announced the results of two health outcomes studies and a placebo controlled randomized trial presented at the American Thoracic Society (ATS) 2015 Annual Meeting in Denver. Results from these studies demonstrated that a substantial proportion of hospitalized chronic obstructive pulmonary disease (COPD) patients are not provided maintenance treatments; one in three patients report low confidence in using COPD devices and a majority of these patients have low treatment adherence; and more patients on Brovana® (arformoterol tartrate) Inhalation Solution reported clinically significant improvements in health-status compared with placebo.
Treatment Patterns for Inpatients with Acute Exacerbation of Chronic Obstructive Pulmonary Disease (Poster Board #P620)
In a retrospective analysis of claims data collected from more than 500 hospitals across the U.S. in 2012, inpatient treatment patterns for patients hospitalized with acute exacerbations of COPD indicated that 78.2 percent were treated with multiple bronchodilators. Only 52.5 percent of patients received long-acting bronchodilators while hospitalized, although the Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) guidelines state that in the hospital prior to discharge, patients should start long-acting bronchodilators, either beta2-agonists and/or anticholinergics with or without inhaled corticosteroids.1
Confidence in Correct Inhaler Device Technique and Its Association with Overall Treatment Adherence: A Retrospective Database Analysis of Real-World US COPD Patients (Poster Board #217)
An analysis of COPD U.S. survey data evaluated physician and patient confidence in correct COPD device usage technique and its association with overall treatment adherence. In 30.0 percent of cases, patients reported higher confidence levels compared with what their physicians reported, although better treatment adherence significantly correlated with physician-reported higher confidence in correct COPD device usage. About 33.0 percent of patients had low confidence in correct COPD device usage and six in ten of this group had low treatment adherence.
“Findings from this analysis further demonstrate the importance of confidence in COPD device use and suggest that a switch to a different device, such as a nebulizer, should be considered for some patients,” said Vamsi Bollu, PhD, MBA, Respiratory Group Director, Health Economics and Outcomes Research, Sunovion.
Improvements in Health Status for Individuals with COPD Treated With Nebulized Arformoterol Tartrate: Results from a 52-Week Trial (Poster Board #620)
In a 52-week multicenter, double blind, parallel-group, placebo-controlled, randomized trial of BROVANA, the Clinical COPD Questionnaire (CCQ), a validated, self-administered, 10-item patient outcomes instrument, was used to measure health status at three, six, and twelve months. Patients treated with BROVANA had greater improvements in self-reported health status compared with placebo-treated patients. At 12 months, 38.3 percent of the BROVANA-treated patients and 30.8 percent of placebo-treated patients reported clinically significant improvements in the CCQ total score.
“COPD can have a detrimental impact on patients’ health status. Improving patient’s health status should be considered a treatment goal along with lung function improvements when making COPD treatment selection,” said Bollu.
“BROVANA is an effective maintenance treatment option for people with COPD and these health outcomes data further validate its benefits and overall value to the COPD community,” said Krithika Rajagopalan, PhD, Head of Global Health Economics and Outcomes Research, Sunovion. “These data underscore the importance of matching patient needs to appropriate device selection, including nebulizers, in improving patient outcomes and reducing healthcare burden of COPD.”
BROVANA is a twice-daily nebulized long-acting beta2-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.
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 beta2-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 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 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, i.e., 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 beta2-agonists. BROVANA should not be used with other medications containing long-acting beta2-agonists. Patients who have been taking inhaled short-acting beta2-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 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.
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 beta2-agonists, should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or drugs known to prolong the corrected QT interval (QTc) 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 trough forced expiratory volume in 1 second (FEV1) improvement 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 more information, please see the full Prescribing Information and Medication Guide for BROVANA.
For additional information, please see the full Prescribing Information and Medication Guide for BROVANA (arformoterol tartrate) Inhalation Solution.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit 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 to improve the lives of patients and their families.
Sunovion, an indirect, wholly owned 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. 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.
BROVANA is a registered trademark of Sunovion Pharmaceuticals Inc.
Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Sumitomo Dainippon
Pharma Co., Ltd.
© 2015 Sunovion Pharmaceuticals Inc.
For a copy of this release, visit Sunovion’s web site at www.sunovion.com
1 From the Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2015. Available from: http://www.goldcopd.org/.