eFlow Included In NDA Submission For Aztreonam Lysine For Inhalation
PARI Pharma's eFlow electronic nebulizer was included in Gilead's recent New Drug Application (NDA) submittal to 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.