- Data demonstrates safety and efficacy of first FDA-approved nebulized formoterol fumarate in patients with moderate to severe COPD - NAPA, Calif., May 16
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
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 www.dey.com, www.accuneb.com, www.curosurfusa.com,
www.cyanokit.com, www.duoneb.com, www.epipen.com and 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.
