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:10/13/2017)... (PRWEB) , ... October 13, ... ... School of Pharmacy (SOP) alumni Hannah Randall, PharmD ‘17, and Jennifer Huggins, ... professionals on guideline updates for the primary prevention of cardiovascular diseases during ...
(Date:10/13/2017)... ... October 13, 2017 , ... Ellevate Network, the leading network for professional women, ... towards gender equality at their inaugural Summit in New York City in June. The ... social audience of over 3 million. To watch the Mobilize Women video, click ...
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the ... danger possible to save lost souls in the Philippines. “The Journey: From the Mountains ... a dedicated teacher of the Bible. She has taught all ages and currently teaches ...
(Date:10/12/2017)... ... 2017 , ... The company has developed a suite of ... authorities worldwide. From Children’s to Adults 50+, every formula has been developed by ... , These products are also: Gluten Free, Non-GMO, Vegan, Soy Free, Non-Dairy*, Preservative ...
(Date:10/12/2017)... (PRWEB) , ... October 12, 2017 , ... ... Mohebi Hair Restoration, has recently contributed a medical article to the newly revamped ... cosmetictown.com. Dr. Mohebi’s article spotlights the hair transplant procedure known as Follicular ...
Breaking Medicine News(10 mins):
(Date:10/7/2017)... 2017   Provista, a proven leader in ... in purchasing power, today announced a new resource area ... Newsroom is the online home for case studies, ... bios, news releases, slideshows and events. ... of resources at their fingertips, viewers can also watch ...
(Date:10/4/2017)... 4, 2017 OBP Medical , ... medical devices, today announced regulatory approval from ... (or Agência Nacional de Vigilância Sanitária (ANVISA)) to ... surgical retractor with integrated LED light source and ... and exposure of a tissue pocket or cavity ...
(Date:10/2/2017)... Halo Labs announces the European launch of their new low volume, ... 2017 in Cambridge, U.K on October 4th. ... samples with unprecedented speed and sensitivity while using far less sample ... ... system ...
Breaking Medicine Technology: