- Data demonstrates safety and efficacy of first FDA-approved nebulized
formoterol fumarate in patients with moderate to severe COPD -
NAPA, Calif., May 16 /PRNewswire/ -- Dey, L.P. announced today that
three clinical data presentations will be given at the International
Conference of the American Thoracic Society (ATS) on May 20, 2008 at the
Metro Toronto Convention Center. One of the presentations details the
effects on dyspnea and other COPD symptoms of using Perforomist(TM)
Inhalation Solution, nebulized formoterol fumarate, adjunctively with
tiotropium to treat COPD patients. The other two presentations compare the
clinical effect of two types of drug delivery - nebulization versus DPI -
when treating COPD patients with formoterol fumarate.
Perforomist(TM) (formoterol fumarate) Inhalation Solution was approved
in 2007 by the FDA for long-term, twice-daily maintenance treatment of
bronchoconstriction in patients with chronic obstructive pulmonary disease
(COPD), including chronic bronchitis and emphysema. It is the only FDA-
approved nebulized formoterol fumarate.
For those attending ATS, the three presentations are available as follows:
-- "Addition of Nebulized Formoterol Fumarate to Tiotropium Treatment
Relieves Dyspnea and Symptoms in COPD Patients," Poster Board #F4
-- "Dose-Ranging Study in COPD Patients Comparing Pharmacodynamics of
Formoterol Fumarate Delivered by Nebulization and DPI," Poster Board
#F13
-- "A Pharmacokinetic Study in COPD Patients Comparing Formoterol Fumarate
Delivered by Nebulization and DPI," Poster Board #F14
Poster Viewing: Tuesday May 20th, 10:45 AM - 12:15 PM EDT
Room: Area F (Halls A-B, North Building, Level 300), Metro Toronto
Convention Centre
Session Info: Thematic Poster Session, [C42] COPD Pharmacotherapy I:
Effects of Bronchodilators
Please note that the principal investigators will be available to
discuss the research results.
About Perforomist(TM) Inhalation Solution
Indication
Perforomist(TM) Inhalation Solution is indicated for the long-term,
twice-daily (morning and evening) administration in the maintenance
treatment of bronchoconstriction in patients with chronic obstructive
pulmonary disease (COPD), including chronic bronchitis and emphysema.
Important Safety Information
Perforomist(TM) Inhalation Solution belongs to a class of medications
known as long-acting beta2-adrenergic agonists (LABAs). LABAs may increase
the risk of asthma-related death. Data from a large placebo-controlled US
study comparing the safety of another LABA (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
formoterol (a LABA), the active ingredient in Perforomist(TM) Inhalation
Solution.
Perforomist(TM) Inhalation Solution should not be used in patients with
acutely deteriorating COPD or to treat acute symptoms. Acute symptoms
should be treated with fast-acting rescue inhalers. Perforomist(TM)
Inhalation Solution should not be used with other medications containing
LABAs. Do not use more than one nebule twice daily. Perforomist(TM)
Inhalation Solution should be used with caution in patients with
cardiovascular disorders. Perforomist(TM) Inhalation Solution is not a
substitute for inhaled or oral corticosteroids. The safety and efficacy of
Perforomist(TM) Inhalation Solution in asthma has not been established.
In COPD clinical trials, the most common adverse events reported with
Perforomist(TM) Inhalation Solution were diarrhea, nausea, nasopharyngitis,
dry mouth, vomiting, dizziness, and insomnia.
Please see full Prescribing Information, including Boxed Warning, at
http://www.perforomist.com or call 800-755-5560 and ask for Customer Service.
About COPD(1)
COPD refers to a number of chronic lung disorders in which the airways
to the lungs become narrowed and breathing becomes increasingly difficult.
The most common forms of COPD are chronic bronchitis and emphysema and many
patients suffer from a combination of the two diseases.
COPD is the fourth leading cause of death in America, behind heart
disease, cancer and stroke. Twelve million Americans have been diagnosed
with COPD and at least another 12 million have symptoms but have not been
diagnosed. COPD is not well understood or recognized - most Americans have
not heard of it, not even those who may be living with the condition. The
most common cause of COPD is cigarette smoking, which is responsible for an
estimated 80 to 90 percent of COPD cases. Estimates of the total incidence
of COPD in America range from 24 to 30 million.
About Nebulization
Of the three types of devices used to deliver bronchodilators --
nebulizers, metered-dose inhalers, and dry powder inhalers -- nebulizers
require no special technique or coordination, as the medication is
converted into a fine mist that the patient inhales through a mouthpiece or
face-mask while breathing naturally.(2) Nebulization is an easy and
effective method of delivering medicine directly into the lungs for
patients, particularly as their symptoms worsen.(3)
With Perforomist(TM) Inhalation Solution, nebulization may become a
more widely used treatment option for many COPD patients at earlier
treatment stages who could benefit from twice-daily maintenance dosing of a
nebulized LABA such as Perforomist(TM) Inhalation Solution. For example,
this new COPD treatment may be a valuable clinical option for many patients
whose symptoms are not adequately controlled with their current therapy.(4)
COPD patients should consider asking their doctor whether nebulized
treatment may be right for them.
About Dey, L.P.
Dey, L.P., a subsidiary of Mylan Inc. (NYSE: MYL), is a specialty
pharmaceutical company focused on the development, manufacturing and
marketing of prescription drug products for the treatment of respiratory
diseases, respiratory-related allergies, and emergency care medicine. As
the U.S. leader in sales of nebulized respiratory medication, Dey, L.P.
puts patients first through its development of innovative and affordable
therapies. The Web sites for Dey, L.P. include http://www.dey.com,
http://www.accuneb.com, http://www.curosurfusa.com, http://www.cyanokit.com, http://www.duoneb.com,
http://www.epipen.com and http://www.perforomist.com.
Perforomist(TM) is a trademark of Dey, L.P.
Media contacts: Dey, L.P. Media Line
1-800-755-5560 ext. 8363
or
Amy Techtmann
Feinstein Kean Healthcare
617-761-6784
amy.techtmann@fkhealth.com
(1) National Heart Lung and Blood Institute. COPD: Are you at Risk? Fact
Sheet. Available at
http://www.nhlbi.nih.gov/health/public/lung/copd/campaign-materials/index.htm
(2) WebMD. "A-Z Health Guide from WebMD." Accessed on May 9, 2006 from
http://www.webmd.com/hw/health_guideatoz/stn166150.asp?navbar=hw32561.
(3) Ibid
(4) Gross, N. et. al. Efficacy and safety of formoterol fumarate delivered
by nebulization to COPD patients. Respiratory Medicine, 2008, 102,
189-197
SOURCE Dey, L.P.
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Related links:
http://www.dey.com
CONTACT:
Dey, L.P. Media Line, +1-800-755-5560, ext.
8363, or Amy Techtmann of Feinstein Kean Healthcare,
+1-617-761-6784, amy.techtmann@fkhealth.com, for Dey, L.P.
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