PARI Respiratory Equipment, Inc, has announced that its proprietary Kitabis Pak has been added to the Preferred Drug List (PDL) in more states across the United States. The Kitabis Pak, which is the co-packaging of tobramycin inhalation solution and the PARI LC PLUS Reusable Nebulizer, is indicated for the management of cystic fibrosis (CF) in adults and pediatric patients 6 years of age and older with P. aeruginosa. A Cystic Fibrosis News Today report indicates that the Pak has been clinically proven to be therapeutically equivalent to TOBI (tobramycin inhalation solution, USP).
The CF treatment also carries the “AN” designation in the Orange Book of the Food and Drug Administration, indicating that “there are no known or suspected bioequivalence problems” associated with the Kitabis Pak. Each Pak contains a 28-day treatment of generic tobramycin inhalation solution and the PARI LC PLUS nebulizer handset, which is currently the only device approved by the FDA for the delivery of tobramycin inhalation solution, according to the Cystic Fibrosis News Today report.
Lisa Cambridge, MSHS, RRT, director of Medical Science & Pharmaceutical Alliances at PARI, states, “Patients with CF that are covered by these Medicaid plans, and prescribed Kitabis Pak will have complete access to the only nebulizer handset used in the clinical trials for tobramycin inhalation solution. The goal of Kitabis Pak is to increase patient access through this strategic co-packaging of both drug and device in one box.”
Mary Lester, RRT, RCP, says, “Expanded patient access to Kitabis Pak is welcome news for both CF patients and healthcare professionals. A new LC PLUS nebulizer handset co-packaged with each course of drug not only improves patient access to the right device, but also helps maintain drug delivery and address the challenges of nebulizer maintenance and acquisition.”
Source: Cystic Fibrosis News Today