Navigation Links
PARI's eFlow Included in Gilead's NDA Submission for Aztreonam Lysine for Inhalation
Date:11/26/2007

MONTEREY, Calif., Nov. 26 /PRNewswire/ -- PARI Pharma's eFlow electronic nebulizer was included in Gilead's (Nasdaq: GILD) recent New Drug Application (NDA) submittal to the U.S. Food and Drug Administration (FDA) for marketing approval of aztreonam lysine for inhalation (75 mg three times daily). Aztreonam lysine for inhalation, delivered by eFlow, is an investigational therapy in development for people with cystic fibrosis (CF) who have pulmonary Pseudomonas aeruginosa (P. aeruginosa) infection.

The NDA is supported by data from two Phase III clinical studies (AIR-CF1 and AIR-CF2) and interim data from an ongoing open-label extension study (AIR- CF3) of patients who participated in AIR-CF1 or AIR-CF2 where eFlow was used exclusively in these trials. The model of the eFlow device used in the trials was optimized from the eFlow platform to deliver the aerosol formulation of aztreonam lysine for inhalation. Aztreonam lysine for inhalation was administered over a two to three minute period in these studies. This represents a significant reduction in aerosol treatment times, as currently available inhalation therapies can average 20 to 25 minutes.

PARI Pharma GmbH, the developer of the eFlow, also contributed to the development and optimization of the drug formulation (aztreonam lysine for inhalation) for delivery with the specific eFlow.

eFlow, an electronic, portable nebulizer, enables extremely efficient aerosolization of liquid medications via a vibrating, perforated membrane that includes thousands of small holes that produce the aerosol mist. Compared to other nebulizer systems, eFlow can produce aerosols with a very high density of active drug, a precisely defined droplet size, and a high proportion of respirable droplets delivered in the shortest possible period of time. Combined with its silent mode of operation, small size (it fits in the palm of your hand), light weight, and battery use, eFlow helps reduce the burden of taking daily, inhaled treatments.

Aztreonam lysine for inhalation is an investigational therapy and has not yet been determined safe or efficacious in humans.

About Cystic Fibrosis

Today, more than 30,000 people in the United States have CF. CF is a chronic, debilitating genetic disease. A major characteristic of CF is production of abnormally thick, sticky mucus in the lungs, trapping bacteria and predisposing patients to lung infections, which continually damage their lungs.

Pulmonary infection with Gram-negative bacteria, particularly pulmonary P. aeruginosa, represents the single greatest cause of morbidity and mortality among CF patients. Currently there is no known cure for CF, and the goal of CF therapy is to control symptoms and prevent further lung damage.

About Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia.

About PARI Pharma

PARI Pharma focuses on the development of aerosol delivery devices and therapies. Based on PARI's 100-year history working with aerosols, PARI Pharma develops treatments for pulmonary and nasal administration optimized to advanced delivery platforms, such as eFlow.

PARI Pharma provides comprehensive inhalation drug development, including nebulizer formulation development and optimization, CMC, analytics, aerosol characterization, clinical protocol development, and regulatory guidance. PARI Pharma has several clinical development programs ongoing, either partnered or on its own. PARI Pharma, a PARI Medical Holding company, is located in Munich, Germany with a major presence in the United States. Online at http://www.paripharma.com


'/>"/>
SOURCE PARI Pharma
Copyright©2007 PR Newswire.
All rights reserved

Related medicine technology :

1. Indevus Announces Submission of New Drug Application
2. BD Announces FDA 510(K) Submission of Rapid Molecular Test to Identify Patients Carrying Staph Superbug Prior to Surgery
3. Data from Three Clinical Trials for Perforomist(TM) Inhalation Solution to be Presented at CHEST 2007 on October 24, 2007
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/23/2017)... Research and Markets has announced the addition of the ... ... capillary electrophoresis market to grow at a CAGR of 7.06% during ... Market 2017-2021, has been prepared based on an in-depth market analysis ... and its growth prospects over the coming years. The report also ...
(Date:3/23/2017)... 23, 2017  Drug diversion is a significant ... deadly overdoses. A new oral fluid monitoring test, ... , reports more detailed and actionable information to ... improve therapy adherence, patient safety, and help to ... Oral fluid Rx Evaluation (CORE) system is the ...
(Date:3/23/2017)... SAN DIEGO , March 23, 2017 /PRNewswire/ ... for fast and accurate identification of individuals who ... at risk for a rare yet potentially deadly ... seizures and bipolar disorder.  The gene HLA-B*15:02 ... hypersensitivity reactions such as Stevens-Johnson syndrome and toxic ...
Breaking Medicine Technology:
(Date:3/23/2017)... ... March 23, 2017 , ... A recent report from the National ... preparation programs. The NCTQ report suggests, based on a review of GPA and SAT/ACT ... teacher quality in the U.S. It argues that this higher bar should be set ...
(Date:3/23/2017)... ... March 23, 2017 , ... Texas Physical Therapy ... 960 Gruene Road in Building 2. The clinic is the group’s second in New ... says opening the company’s second New Braunfels location brings things full circle for the ...
(Date:3/23/2017)... and Grimsby, Ontario (PRWEB) , ... March 23, 2017 , ... The MBI “Hall of ... industry or whose acts have had a significant impact on the careers of all others ... Marketing with NRB Inc. was inducted into the MBI’s Hall of Fame. The induction ...
(Date:3/23/2017)... ... 23, 2017 , ... March is National Kidney Month – the perfect time ... to maintaining good health. Every day, two kidneys filter about 120 to 150 quarts ... your blood, eliminating waste, regulating fluid levels and blood pressure, supporting bone health and ...
(Date:3/23/2017)... ... March 23, 2017 , ... Hakim Unique Group (HUG) ... company California Healthcom Group (CHG). , The HUG investment is a landmark ... in California, CHG is a growing, internationally recognized healthcare management, technology, and services ...
Breaking Medicine News(10 mins):