PARI, a company working on the development and commercialization of effective aerosol delivery systems (drug and device) for patients suffering from respiratory disorders like cystic fibrosis, chronic lung disease and asthma, has announced the first patient enrolled in the company’s PARI PROVIDE compressor access program. The program is designed to accompany the launch of PARI’s FDA-approved Kitabis Pak — a drug and device combination that co-packages generic tobramycin inhalation solution with the PARI LC PLUS Nebulizer for patients with cystic fibrosis. PARI PROVIDE will give users of the Kitabis Pak access to an air compressor needed to administer the therapy.
Cystic fibrosis is a life-threatening genetic disease that causes the body to produce unusually thick mucus that can result in serious respiratory and gastrointestinal manifestations. The Kitabis Pak is used by individuals with cystic fibrosis that have an infection caused by the bacteria Pseudomonas aeruginosa. Infection by these bacteria when combined with cystic fibrosis can easily colonize the lungs, causing severe complications in lung function and overall well-being.
Kitabis Pak is a kit that combines two components: a drug called Tobramycin Inhalation Solution, and a drug delivery device – PARI LC PLUS Reusable Nebulizer. Tobramycin is an antibacterial drug prescribed to treat individuals who are at least 6 years of age, suffer from cystic fibrosis and have an infection from Pseudomonas aeruginosa. The PARI LC PLUS is the only nebulizer that has been approved by the Food and Drug Administration (FDA) to deliver Tobramycin Inhalation Solution in a safe and effective manner.
A compressor is required to deliver the Tobramycin Inhalation Solution via the PARI LC PLUS nebulizer, as the liquid medication needs to be transformed into an inhalable mist. The launch of PARI PROVIDE, a patient access program that provides the correct and approved compressor to patients, will make it easier for Kitabis Pak patients to get access to the correct air compressors for administering the therapy.
“Kitabis Pak makes taking nebulized tobramycin easier because it is one prescription for both the drug and nebulizer handset. 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,” explained Geoff Hunziker, president of PARI USA, in a news release.
“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. A lot of work went into the original clinical trials,” concluded Lisa Cambridge, director of Medical Science at PARI USA. “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.”