CaystonTreatment for Pneumonia with Cystic Fibrosis
PARI's eFlow Included in Gilead's NDA Submission for Aztreonam Lysine for Inhalation
MONTEREY, Calif., November 26, 2007 /PRNewswire/ -- PARI Pharma's eFlow electronic nebulizer was included in Gilead's 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.
Posted: November 2007
- U.S. Food and Drug Administration Approves Cayston (Aztreonam for Inhalation Solution) for the Improvement of Respiratory Symptoms in Cystic Fibrosis Patients with Pseudomonas Aeruginosa - February 23, 2010
- FDA Advisory Committee Supports Use of Aztreonam for Inhalation Solution for Patients With Cystic Fibrosis - December 11, 2009
- Gilead's Aztreonam for Inhalation Solution to be Reviewed by FDA Anti-Infective Drugs Advisory Committee on December 10, 2009 - October 26, 2009
- Gilead Receives Response From U.S. FDA on Company's Request for Formal Dispute Resolution for Aztreonam for Inhalation Solution - February 19, 2009
- Gilead Receives Complete Response Letter from U.S. Food and Drug Administration for Aztreonam Lysine for Inhalation, an Investigational Treatment for Cystic Fibrosis - September 17, 2008
- Gilead Submits New Drug Application to U.S. FDA for Aztreonam Lysine for Inhalation for Cystic Fibrosis - November 16, 2007