The US Food and Drug Administration (FDA) has approved the first electronic nebulizer to deliver cystic fibrosis patients their therapy.
The agency approved PARI’s eRapid nebulizer system to deliver Genentech’s Pulmozyme (dornase alfa [recombinant human DNase] for treatment of cystic fibrosis (CF). According to PARI, eRapid cuts the average treatment time with Pulmozyme from six to eight minutes down to two to three minutes, providing a significant convenience for CF patients. Both adult and pediatric patients strongly preferred eRapid over conventional nebulizers in a clinical study.
“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. As the first electronic nebulizer to deliver Pulmozyme, eRapid is a true breakthrough for cystic fibrosis patients who take the therapy daily, often for years,” said Lisa Cambridge, director of Medical Science and Pharmaceutical Alliances at PARI Respiratory Equipment, Inc.
According to the company, the delivery system, part of a variety of nebulizers offered by PARI, has been distributed in Europe for years, with a high approval rate among patients.
In the Pulmozyme clinical trial, there was a 10:1 preference for eRapid in the pediatric group and a 20:1 preference in the adult group, which confirmed the company’s decision to bring eRapid to the US, according to PARI USA’s President Geoff A. Hunziker.
“After the successful results of a Phase IV study, we are confident that physicians will see that both pediatric and adult patients favor eRapid based on reduced treatment times, quiet operation, and its small, portable size. We were also happy to see that patients were more satisfied with treatment and eRapid had a positive influence on adherence – good for their overall cystic fibrosis management,” said Cambridge.
CF is a life-threatening genetic disease that primarily affects the lungs and digestive system. According to the Cystic Fibrosis Foundation, there are an estimated 30,000 children and adults in the US with CF and 70,000 worldwide. In CF patients, the body produces unusually thick, sticky mucus that clogs the lungs and leads to life-threatening lung infections and obstructs the pancreas and stops natural enzymes from helping the body break down food and absorb vital nutrients.
Sources: PARI Respiratory Equipment; Cystic Fibrosis Foundation