- Data from two clinical trials presented at International ATS Conference -
NAPA, Calif., May 20 /PRNewswire/ -- Data presented today at the
International Conference of the American Thoracic Society (ATS) demonstrate
that Perforomist(TM) Inhalation Solution (formoterol fumarate inhalation
solution; FFIS) has a pharmacodynamic and pharmacokinetic profile that is
comparable to the dry powder inhaler (DPI) formulation of formoterol
fumarate, Foradil(R) Aerolizer(R) 12mcg (FA).
Perforomist(TM) (formoterol fumarate) Inhalation Solution, the only
FDA- approved nebulized formoterol fumarate, 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.
The first of the two studies presented, "Dose-Ranging Study in COPD
Patients Comparing Pharmacodynamics of Formoterol Fumarate Delivered by
Nebulization and DPI," showed that 20mcg of FFIS (Perforomist(TM)
Inhalation Solution) delivered by nebulization provides bronchodilation
comparable to DPI delivery.
The second study; "A Pharmacokinetic Study in COPD Patients Comparing
Formoterol Fumarate Delivered by Nebulization and DPI," showed
comparability in linear kinetics and excreted drug levels between
formoterol fumarate administered by nebulization and DPI. Transient and
dose-related effects on serum potassium, serum glucose and vital signs were
observed and found to be comparable between the two formulations.
Dr. Nicholas J. Gross, MD, PhD, Hines VA Hospital, Stricht Loyola
School of Medicine and lead clinical investigator in the first study,
commented, "The results of both of these studies provide additional
evidence of the clinical benefit of Perforomist(TM) Inhalation Solution as
a valuable treatment option for patients with COPD. Nebulization is an
alternative way to deliver medication to the lungs and since many patients
may have difficulty coordinating the use of other devices as their disease
progresses, nebulized Perforomist(TM) offers an effective, long-term
treatment option."
The first study was a single-dose, double-blind, double-dummy crossover
dose-ranging study conducted in 47 patients to establish the dose of
Perforomist(TM) Inhalation Solution comparable to that of the marketed DPI,
Foradil(R) Aerolizer(R). Mean FEV(1) AUC(0-12) (standardized area under the
curve for FEV(1) over twelve hours) following FFIS treatment ranged from
1.3 to 3.0 L/hr in a dose-related manner, with identical values (2.3 L/hr)
for Perforomist(TM) Inhalation Solution 20mcg and Foradil(R) Aerolizer(R).
All other spirometry measures were comparable between FFIS and FA.
The second study involving thirteen COPD patients was a randomized,
single-dose, open-label, crossover study comparing FFIS 10, 20, and 24mcg
with Foradil(R) Aerolizer(R), which confirmed pharmacokinetic comparability
between Perforomist(TM) Inhalation Solution 20mcg by nebulization and
Foradil(R) Aerolizer(R) 12mcg (Foradil) by DPI.
"This research continues to support and highlight the clinical value of
Perforomist(TM) Inhalation Solution," said Carolyn Myers, Ph.D., President
of Dey, L.P. "We thank all of these eminent researchers for their
contributions to the trials that were presented today and we remain
dedicated to developing nebulized treatment options for those suffering
from serious respiratory illnesses such as COPD."
For those attending ATS 2008, the presentations are available as follows:
Poster viewing: Session ID C42 COPD Pharmacotherapy I: Effects of
Bronchodilators
Tuesday, May 20, 2008, 10:45 a.m. - 12:30 p.m. EDT
Metro Toronto Convention Center; Area F: Halls A-B North Building, Level
300
-- Poster #F13: Dose-Ranging Study in COPD Patients Comparing
Pharmacodynamics of Formoterol Fumarate Delivered by Nebulization and
DPI
-- Poster #F14: A Pharmacokinetic Study in COPD Patients Comparing
Formoterol Fumarate Delivered by Nebulization and DPI
The research presented at ATS 2008 was supported through grants
provided by Dey, L.P., which developed and markets Perforomist(TM)
Inhalation Solution. Dey, L.P. is a subsidiary of Mylan Inc. (NYSE: MYL).
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 beta(2)-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.
Foradil(R) Aerolizer(R) is a registered trademark of Novartis Pharma AG
(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
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
SOURCE Dey L.P.
 back to top
Related links:
http://www.dey.com
http://www.perforomist.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
|
