Sunovion Pharmaceuticals Inc. Announces Data Published in the CHEST Journal from a One-year, Large Simple Safety Study Evaluating BROVANAВ® (arformoterol tartrate) Inhalation Solution
MARLBOROUGH, Mass.--(BUSINESS WIRE)--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 BROVANAВ®
(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.
Diovan (Valsartan) with no Rx The complete
study is available on the journal’s website: 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.
About Diovan Hct (Valsartan-Hydrochlorothiazide) with free Rx 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.
About Diamox (Acetazolamide) with free prescription “This study supports BROVANA as a safe and
effective treatment option for COPD patients.”
BROVANA is a twice-daily nebulized long-acting beta2 agonist
(LABA) approved by the U.S.
About Baxan with free prescription 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.
Buy Digestion Supplements online Among 841 subjects, 466 completed one year of
treatment.
http://cholesterolreviews.wordpress.com 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 (FEV1) 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 BROVANAВ®
В
WARNING: ASTHMA-RELATED DEATH
В
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, 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 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 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 FEV1В 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 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 .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 AlvescoВ®(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 .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 .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.В©
2014 Sunovion Pharmaceuticals Inc.
For a copy of this release, visit Sunovion’s web site at .sunovion.com
1 .cdc.gov/copd/2
.nhlbi.nih.gov/resources/docs/2009_ChartBook.pdf
