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www.fdanews.com/articles/169733-fda-approves-paris-erapid-nebulizer-system-for-cystic-fibrosis-drug-delivery

FDA Approves PARI’s eRapid Nebulizer System for Cystic Fibrosis Drug Delivery

January 28, 2015

Richmond, Va., devicemaker PARI Respiratory Equipment said Monday that the FDA approved its eRapid Nebulizer System to deliver Genetech’s Pulmozyme, making it the first electronic nebulizer for use with the cystic fibrosis drug. eRapid reduces average Pulmozyme (dornase alfa) treatment times from 6 to 8 minutes to 2 to 3 minutes, the company said.

In a clinical study, both adult and pediatric patients with CF showed a strong preference for eRapid over conventional nebulizers, PARI said. "We have been pleased with eRapid's fast treatment times in the lab and are excited that patients now have access to a much faster Pulmozyme therapy,” said Lisa Cambridge, PARI’s director of medical science and pharmaceutical alliances. 

eRapid is available by prescription through a select group of specialty pharmacies that can offer both the drug and the nebulizer, PARI spokeswoman Kirsten Ayars said.

The eRapid Nebulizer System was first cleared by FDA in May 2012 as a general-use nebulizer, Ayars added.  — Kellen Owings