- Study shows significantly improved bronchodilation and symptom control
with combination therapy -
NAPA, Calif., May 20 /PRNewswire/ -- A newly published study presents
data demonstrating that patients with Chronic Obstructive Pulmonary Disease
(COPD), including emphysema and chronic bronchitis, experienced markedly
improved bronchodilation and symptom control when treated with a
combination of nebulized formoterol fumarate inhalation solution
(Perforomist(TM) Inhalation Solution) and tiotropium (TIO), compared to
treatment with tiotropium alone. The two medications, when used
adjunctively, were also well tolerated by patients over the course of the
6-week study.
"Concomitant Treatment with Nebulized Formoterol and Tiotropium in
Subjects with COPD: A Placebo-Controlled Trial," published in Respiratory
Medicine, assesses the efficacy and safety of the concomitant treatment of
Perforomist(TM) nebulized formoterol fumarate (a long-acting beta-agonist
[LABA]) and tiotropium (an anticholinergic) in 130 adults with moderate to
severe COPD.
"These data provide additional insight into the additive benefit of
concomitant therapy with a LABA and a long-acting anticholinergic," said
Dr. Donald Tashkin, MD, FACP, FCCP, Professor of Medicine, David Geffen
School of Medicine at the University of California at Los Angeles, lead
author and principal investigator of the study. "When Perforomist(TM)
Solution's rapid onset of action is combined with tiotropium's prolonged
bronchodilation, the result appears to be a safe and effective treatment
option for patients. This is great news for the millions of patients -- and
their families -- who live with COPD, and who too often struggle with an
insufficient number of robust treatment options."
About the Study
The study was a six-week, randomized, double-blind, placebo-controlled,
parallel-group design study. COPD patients entered a 7-14 day run-in period
during which subjects received once-daily treatment with tiotropium bromide
inhalation powder (TIO; Spiriva(R), 18mcg) administered with a
HandiHaler(R). Following randomization, subjects entered a six-week
treatment period to evaluate the safety and efficacy of formoterol fumarate
inhalation solution (FFIS; Perforomist(TM), 20mcg/2mL) while maintaining
once-daily treatment with TIO. The primary efficacy endpoint was
standardized area under the curve for FEV(1) over three hours (FEV(1)
AUC(0-3)) at the last visit (week 6).
The standardized absolute AUC(0-3) for FEV(1) following the first dose
of study medication at Day 1 was statistically significantly improved in
the Perforomist(TM)/TIO group compared with placebo/TIO group (PLA/TIO).
FEV(1) AUC(0-3) remained significantly greater in the Perforomist(TM)/TIO
group after six weeks without any decrease of effect or evidence of
tolerance (p< 0.0001). Peak FEV(1) levels were significantly higher in the
Perforomist(TM)/TIO group compared with PLA/TIO (p< 0.0001). Symptoms,
including shortness of breath, chest tightness, night-time awakenings, and
the total respiratory symptom score, were all significantly improved in the
Perforomist(TM)/TIO group compared with PLA/TIO. Use of albuterol rescue
medication declined in the Perforomist(TM)/TIO group and remained low
throughout the treatment, whereas albuterol use in the PLA/TIO group
trended higher through the six weeks of treatment (p<0.0001), suggesting
enhanced control of COPD symptoms.
Quality of life was assessed with St. George's Respiratory
Questionnaire (SGRQ), the results of which were similar at day 1 and did
not change markedly over the six weeks of treatment. The only statistically
significant and clinically relevant treatment difference observed with
Perforomist(TM)/TIO compared with PLA/TIO was an improvement in symptom
score (LS mean change of - 5.8 units).
Other Recently Published Data
Results from the Phase III pivotal trial of Perforomist(TM) (formoterol
fumarate) Inhalation Solution, the first and only FDA-approved nebulized
formoterol fumarate, were also recently published. Perforomist(TM)
Inhalation Solution is indicated for long-term, twice-daily maintenance
treatment of COPD.
-- "Efficacy and Safety of Formoterol Fumarate Delivered by Nebulization
to COPD Patients," published in the February 2008 issue of Respiratory
Medicine, detailed pivotal Phase III data that supported the NDA
approval for Perforomist(TM) (formoterol fumarate) Inhalation Solution.
The study demonstrated that Perforomist(TM) Inhalation Solution has a
rapid onset of significant bronchodilation within five minutes of
administration and is safe and effective. The study assessed the
efficacy and safety of Perforomist(TM) Inhalation Solution in 351
adults with moderate-to-severe COPD. Nicholas J. Gross, MD, PhD, Hines
VA Hospital, Stricht Loyola School of Medicine, was lead author and
principal investigator of the study.
-- In October 2007, Clinical Therapeutics published cardiac safety results
from the Phase III trial for Perforomist(TM) Inhalation Solution. In
"Cardiac Safety Profile of Nebulized Formoterol in Adults with COPD: A
12-Week, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo-
and Active-Controlled Trial," the data showed that Perforomist(TM)
Inhalation Solution was associated with rapid and sustained improvement
in pulmonary function with no clinically significant cardiac effects,
including QT prolongation, increased proarrhythmic events, or changes
in serum potassium levels. Harold S. Nelson, MD, Professor of
Medicine, National Jewish Medical and Research Center; was lead author
of the article and principal investigator of the study. Patients with
cardiac problems were excluded from the study. Perforomist(TM) should
be used with caution in patients with cardiovascular disorders,
especially coronary insufficiency, cardiac arrythmias, and
hypertension.
Funding for these studies was provided by Dey, L.P., manufacturer and
marketer of Perforomist(TM) (formoterol fumarate) Inhalation Solution.
Perforomist(TM) Inhalation Solution is the first and only FDA-approved
nebulized form of formoterol fumarate. Formoterol fumarate is a rapid and
long-acting beta(2)-agonist (LABA) that has been previously available in
the U.S. in a dry powder formulation with twenty years of worldwide
experience. Nebulizers convert liquid medication into a mist that patients
inhale through a mouthpiece or facemask.
"Taken together, these studies expand our understanding of the clinical
benefits of Perforomist(TM) Inhalation Solution for the treatment of COPD,"
said Carolyn Myers, Ph.D., President of Dey, L.P. "Perforomist Inhalation
Solution offers physicians a flexible, safe, and highly effective treatment
option for COPD -- and many patients may benefit from this new addition to
the treatment armamentarium."
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 that 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 may 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.
Spiriva(R) is a registered trademark of Boehringer Ingelheim
Pharmaceuticals, Inc.
HandiHaler(R) is a registered trademark of Boehringer Ingelheim
Pharmaceuticals, Inc.
(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.
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Related links:
http://www.perforomist.com
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
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