Navigation Links
Perforomist-comparable pharmacokinetic and pharmacodynamic profile to DPI formulation
Date:5/20/2008

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
amy.techtmann@fkhealth.com
617-761-6784
Feinstein Kean Healthcare
Source:Eurekalert

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:
*Name:
*Comment:
*Email:
(Date:6/25/2016)... ... 2016 , ... Conventional wisdom preaches the benefits of moderation, whether it’s a ... the bar too high can result in disappointment, perhaps even self-loathing. However, those who ... , Research from PsychTests.com reveals that behind the tendency to set ...
(Date:6/24/2016)... ... ... was in a crisis. Her son James, eight, was out of control. Prone to extreme ... “When something upset him, he couldn’t control his emotions,” remembers Marcy. “If there was ... other children and say he was going to kill them. If we were driving ...
(Date:6/24/2016)... , ... June 24, 2016 , ... Comfort Keepers® of ... Cancer Society and the Road To Recovery® program to drive cancer patients to and ... other adults to ensure the highest quality of life and ongoing independence. Getting ...
(Date:6/24/2016)... ... June 24, 2016 , ... The Haute Beauty Network, affiliated ... Weintraub as a prominent plastic surgeon and the network’s newest partner. , ... most handsome men, look naturally attractive. Plastic surgery should be invisible.” He stands ...
(Date:6/24/2016)... ... June 24, 2016 , ... Venture Construction Group (VCG) sponsors Luke’s ... June 20th at the Woodmont Country Club at 1201 Rockville Pike, Rockville, Maryland, 20852. ... helping service members that have been wounded in battle and their families. Venture Construction ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... -- According to a new market research ... Safety Pen Needles), Needle Length (4mm, 5mm, 6mm, 8mm, ... Purchase (Retail, Non-Retail) - Trends & Global Forecasts to ... for the forecast period of 2016 to 2021. This ... 2021 from USD 1.65 Billion in 2016, growing at ...
(Date:6/23/2016)... HOUSTON , June 23, 2016  MedSource ... platform as its e-clinical software solution of choice.  ... the best possible value to their clients by ... nowEDC.  The preferred relationship establishes nowEDC as the ... pricing for MedSource,s full-service clients.  "nowEDC has long ...
(Date:6/23/2016)...  In a startling report released today, National Safety Council ... a comprehensive, proven plan to eliminate prescription opioid overdoses. ... states are tackling the worst drug crisis in recorded U.S. history, ... Kentucky , New Mexico , ... the 28 failing states, three – Michigan , ...
Breaking Medicine Technology: