-- Clinical trial data for Perforomist(TM) (Formoterol Fumarate) Inhalation
Solution 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 concomitant therapy with Perforomist(TM) Inhalation Solution
(formoterol fumarate inhalation solution; FFIS), delivered by nebulization,
and Spiriva(R) (tiotropium; TIO) is significantly more effective than
treatment with tiotropium alone.
Perforomist(TM) 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.
Donald P. Tashkin, MD, FACP, FCCP, Professor of Medicine, David Geffen
School of Medicine at the University of California at Los Angeles and lead
clinical investigator, presented the results from "Addition of Nebulized
Formoterol Fumarate to Tiotropium Treatment Relieves Dyspnea and Symptoms
in COPD Patients" in a poster session today.
"In this study there was a significant improvement in patients treated
concomitantly with Perforomist(TM) nebulized formoterol fumarate and
tiotropium over tiotropium alone," said Dr. Tashkin. "These data provide
physicians with a new and valuable treatment option for COPD patients with
moderate to severe manifestations of the disease."
This randomized, placebo-controlled double-blind trial was conducted in
130 patients with moderate to severe COPD to evaluate the efficacy and
safety of Perforomist(TM), nebulized FFIS, when added to Spiriva
maintenance treatment. Patient-centered outcomes were measured by the
baseline/transitional dyspnea index, daily recording of COPD symptoms,
rescue albuterol use and St. George's Respiratory Questionnaire (SGRQ).
In this trial there was a statistical significance between the mean
transitional dyspnea index scores in the Perforomist(TM)/TIO and
TIO/placebo groups (2.30 and 0.16, respectively; p=0.0002). Shortness of
breath, chest tightness, nighttime awakenings, and total symptom scores all
improved significantly with the Perforomist(TM)/TIO treatment compared with
TIO/placebo (p<0.05). Cough scores did not differ between groups. Albuterol
use declined in the Perforomist(TM)/TIO group from 2.4 to1.3 puffs/day and
increased in the TIO/placebo group from 2.8 to 3.4 puffs/day over six
weeks; another statistically significant difference (p< 0.0001). SGRQ total
scores did not change markedly from baseline or differ between groups
except for the symptom domain score, which was superior in the
Perforomist(TM)/TIO group compared to TIO/placebo (-6.3, p<0.04).
"DEY is very pleased with the results of this study and the benefit
that patients are seeing with Perforomist(TM) Inhalation Solution," said
Carolyn Myers, Ph.D., President of Dey, L.P. "We wish to thank Dr. Tashkin
and the other members of the research team for their careful investigation
into the clinical benefits of concomitant therapy of Perforomist and
tiotropium. At DEY, we are committed to developing effective new treatments
for serious and complex diseases, and with Perforomist are proud to provide
physicians and patients a twice-daily COPD maintenance medication that
offers the flexibility of dosing via nebulization."
For those attending ATS 2008, the presentation is 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 # F4: Addition of Nebulized Formoterol Fumarate to Tiotropium
Treatment Relieves Dyspnea and Symptoms in COPD Patients
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 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.
Spiriva(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.dey.com
http://www.accuneb.com http://www.curosurfusa.com
CONTACT:
Dey, L.P. Media Line, +1-800-755-5560 ext.
8363; or Amy Techtmann of Feinstein Kean Healthcare for Dey,
L.P., +1-617-761-6784, amy.techtmann@fkhealth.com
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