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news.PARI Pharma's eFlow electronic nebulizer has been included in Gilead's recent new drug application to the FDA for marketing approval of aztreonam lysine for inhalation, which is an investigational therapy in development for cystic fibrosis patients who have pulmonary Pseudomonas aeruginosa infection.
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The new drug application (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.
eFlow, an electronic, portable nebulizer, enables efficient aerosolization of liquid medications via a vibrating, perforated membrane that includes thousands of small holes that produce the aerosol mist. According to PARI Pharma, 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.