FDA Clears First Electronic Nebulizer for Patients With CF

Megan Brooks

Disclosures

January 27, 2015

The US Food and Drug Administration (FDA) has approved the eRapid nebulizer system (PARI), the first electronic nebulizer to deliver dornase alfa (Pulmozyme, Genentech) for the treatment of cystic fibrosis (CF), PARI has announced.

According to the company, eRapid cuts the average treatment times with Pulmozyme from 6 to 8 minutes down to 2 to 3 minutes. In a clinical trial, there was a 10:1 preference for eRapid in children and a 20:1 preference in adults.

"For many years, eRapid has been successfully distributed in Europe (as eFlow Rapid) with favorable feedback from patients with CF," Geoff A. Hunziker, president of PARI USA, said in a news release.

"PARI was motivated to introduce eRapid to the US market based on encouragement from the Cystic Fibrosis Foundation and their input to have a general-use, electronic nebulizer that could improve therapy adherence," he added.

In a phase 4 study, "patients were more satisfied with treatment and eRapid had a positive influence on adherence — good for their overall [CF] management," Lisa Cambridge, director of medical science and pharmaceutical alliances at PARI Respiratory Equipment, Inc, added in the release.

CF is life-threatening genetic disease affecting an estimated 30,000 children and adults in the United States and 70,000 worldwide, according to the Cystic Fibrosis Foundation. Pulmozyme is used, along other therapies, to improve lung function in patients with the disease.

eRapid is available now by prescription through a select group of specialty pharmacies. For more information, visit the PARI website or call 1-800-FAST-NEB.

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