Navigation Links
Perforomist-comparable pharmacokinetic and pharmacodynamic profile to DPI formulation

Napa, CA (May 20, 2008) Data presented today at the International Conference of the American Thoracic Society (ATS) demonstrate that Perforomist™ 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® Aerolizer® 12 g (FA).

Perforomist™ (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 20 g of FFIS (Perforomist™ 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™ 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™ 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™ Inhalation Solution comparable to that of the marketed DPI, Foradil® Aerolizer®. Mean FEV1 AUC0-12 (standardized area under the curve for FEV1 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™ Inhalation Solution 20 g and Foradil® Aerolizer®. 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 24 g with Foradil® Aerolizer®, which confirmed pharmacokinetic comparability between Perforomist™ Inhalation Solution 20 g by nebulization and Foradil® Aerolizer® 12 g (Foradil) by DPI.

This research continues to support and highlight the clinical value of Perforomist™ 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.


Contact: Amy Techtmann
Feinstein Kean Healthcare

Related medicine news :

1. Phase I pharmacokinetic study of ECO-4601, a novel bifunctional targeting agent
2. Fry Construction Selected for High-Profile Medical Imaging Project
3. CIGNA Behavioral Health Offers Members Online Provider Profiles
4. Los Angeles Jewish Home Support Group Continues High-Profile Speaker Program With Noted Legal Scholar and Expert Laurie L. Levenson
5. Waterville Investment Research Profiles Impact Medical Solutions
6. ENDEAVOR IV achieves primary endpoint, demonstrates similar safety profile compared to Taxus stent
7. INVEGA(TM) Shows Favorable Long-Term Safety Profile in a One-Year Study of Patients With Schizophrenia
8. Randone Trasylol Lawsuit Profiled on CBS 60 Minutes
9. MHA Announces Initial Results of the Specialty Pharmacy Member Profile Initiative
10. GSK Data Suggests Efficacy of Advair(R) and Serevent(R) is Not Impacted by Genetic Profile
11. Photos: Compact Barbell System With Flat, Streamlined Profile Travels Easily and Stores Conveniently
Post Your Comments:
(Date:11/24/2015)... ... November 24, 2015 , ... Charitable giving is at ... are made in the last five weeks of the year totalling over $358 billion ... 2012 to connect the nation’s charities with those individuals who want to “give back” ...
(Date:11/24/2015)... CA (PRWEB) , ... November 24, 2015 , ... ... sizes, has launched their Black Friday sale a week early, offering 40% off ... to transform the intimate apparel industry through both mobile fit technology and the ...
(Date:11/24/2015)... Los Angeles, CA (PRWEB) , ... November 24, 2015 , ... ... author explored the different restrictions and variables that determine which patients are or are ... are those patients that have a BMI over 40, are more than 100 pounds ...
(Date:11/24/2015)... ... November 25, 2015 , ... Catalent ... for drugs, biologics, consumer health and global clinical supply services, today announced that ... Clinical Trial Supply East Asia Conference, to be held at the InterContinental Seoul ...
(Date:11/24/2015)... ... November 24, 2015 , ... DMG Productions announced that they ... airing first quarter 2016 via Discovery Channel. Dates and show times TBA. , Aphria, ... is in the business of producing and supplying medical marijuana pursuant to the Marijuana ...
Breaking Medicine News(10 mins):
(Date:11/24/2015)... 2015  Thanks to a donor with a personal ... Center,s Sister Diane Grassilli Center for Women,s Health now ... San Francisco . Fred ... with a gift of $617,320 that allowed the Center ... Tomosynthesis and Whole Breast Ultrasound. Tomosynthesis, three-dimensional (3-D) mammography ...
(Date:11/24/2015)... Nov. 24, 2015  Natera, Inc. (Nasdaq: ... genetic testing and the analysis of circulating ... present at the 27 th  Annual Piper ... 2015 at 1:00 p.m. ET.  Matthew Rabinowitz, Ph.D., CEO of ... business activities and financial outlook. ...
(Date:11/24/2015)... , Nov. 24, 2015  Array BioPharma Inc. ... Chief Executive Officer, Ron Squarer , will ... in New York.  The public is welcome to ... the Array BioPharma website.Event:Piper Jaffray Annual Healthcare ConferencePresenter:  ... December 2, 2015Time:1:30 p.m. Eastern Time Webcast: ...
Breaking Medicine Technology: