PARI Respiratory Equipment, Inc. recently announced the enrollment of the first cystic fibrosis (CF) patient in its compressor access program called PARI PROVIDE, designed to support the launch of the Kitabis Pak. The product includes a combination of a drug and the device, which has already received approval from the U.S. Food and Drug Administration (FDA) and is expected to become the first co-packaging of generic tobramycin inhalation solution to use a PARI LC PLUS Nebulizer.
Since cystic fibrosis patients regularly need multiple inhaled medications for which they need to use a compressor to boost the nebulization and liquid medication, the company is aiming to provide a simpler solution, comprised of both the generic inhaled drug tobramycin and the nebulizer. The PARI PROVIDE program will ensure that users of the Kitabis Pak gain access to an air compressor that works with the product.
“Kitabis Pak makes taking nebulized tobramycin easier because it is one prescription for both the drug and nebulizer handset,” said the president of PARI U.S.A., Geoff Hunziker in a press release. “Distribution delays are eliminated because both the drug and nebulizer handset are dispensed together. PARI PROVIDE takes the program one step further by providing patients with the only FDA approved compressor to deliver tobramycin inhalation solution.”
In addition, the director of Medical Science at PARI Respiratory U.S.A., Lisa Cambridge, added that “it is important for patients to know that tobramycin inhalation solution is only approved for use with the nebulizer handset in Kitabis Pak and the compressor included in PARI PROVIDE.” Both the Kitabis Pak and the compressor access program PARI PROVIDE are exclusively marketed by PARI Respiratory.
Speaking about the current studies to evaluate the combined therapy, Cambridge said that “a lot of work went into the original clinical trials. The components of Kitabis Pak and PARI PROVIDE give patients with cystic fibrosis full access to what the FDA approved as an effective inhaled antibiotic therapy.” Kitabis Pak resembles the ones used as treatment for asthma and chronic obstructive pulmonary disease (COPD), and the price is similar to that of the generic tobramycin drug alone.
It was last December when the FDA granted final approval of the Company’s New Drug Application for the Kitabis Pak, given its indication for the treatment of respiratory infections caused by Pseudomonas aeruginosa in adult and pediatric patients with CF. PARI Respiratory is dedicated to the development of aerosol delivery systems for various pulmonary conditions such as asthma, chronic lung disease, RSV infections, VAP, and HAP, in addition to CF.