The U.S. Food and Drug Administration (FDA) has announced that Kitabis Pak, a co-packaging of generic tobramycin inhalation solution with the PARI LC PLUS Nebulizer developed by PulmoFlow, Inc. has been granted final approval. The combined treatment is currently in stock and will become available through PARI Respiratory Equipment, Inc.

With the FDA approval, Kitabis Pak has become the first nebulized drug and device combination for the treatment of patients suffering from cystic fibrosis (CF). It works in a similar way to the inhalers that patients use for asthma or chronic obstructive pulmonary disease (COPD) that include both the drug and the device together.

“Our goal is to streamline the process so patients receive tobramycin inhalation solution with the nebulizer proven to deliver it effectively,” stated the president of PARI USA, Geoff Hunziker. “Kitabis Pak is the easiest and most cost effective way for doctors to prescribe nebulized tobramycin without the added hassle of a separate nebulizer prescription or cost.”

“The FDA approval and more than a decade of experience of using tobramycin solution for inhalation is based on the delivery by the PARI LC PLUS Nebulizer for safety and efficacy of treatment. No other nebulizer has been proven to be as safe or effective as the original,” added the  former executive vice-president of Research & Development for TOBI, Bruce Montgomery, M.D.

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While the approval is good news, Cheryl Velotta, LPN/CRT of UH Rainbow Babies and Children’s Hospital notes the importance of ensuring that patients are aware of it. Because it is the only approved and proven delivery system for nebulized tobramycin, it “is very important both for the patient and healthcare professional,” she explained. “Knowing that we don’t have to worry about the device any longer is a huge benefit when we prescribe nebulized tobramycin,” she added.

In order to increase the range of the new therapy, PARI is launching along with Kitabis Pak a compressor access program, designed specially for patients who lack a proper compressor to deliver the tobramycin inhalation solution, called PARI PROVIDE. PulmoFlow expects it to set a new standard of care regarding nebulized drugs, and its price will be similar to the current price of the generic tobramycin drug alone.