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FDA Approves Tobramycin and Nebulizer Combo for Cystic Fibrosis
The FDA has granted final approval of a new drug application for Kitabis Pak (PulmoFlow, Inc.) –– a co-packaging of generic tobramycin inhalation solution with a PARI LC Plus nebulizer. It is the first nebulized drug and device combination to be approved for patients with cystic fibrosis (CF). Kitabis Pak is available through PARI Respiratory Equipment, Inc.
The price of the combo product will be similar to the price of generic tobramycin alone.
Kitabis Pak is indicated for the management of CF in adults and pediatric patients 6 years of age and older with Pseudomonas aeruginosa infection. The product’s safety and efficacy have not been demonstrated in patients under the age of 6 years, in patients with a forced expiratory volume in 1 second (FEV1) of less than 25% or greater than 75% predicted, or in patients colonized with Burkholderia cepacia.
Tobramycin is an aminoglycoside antibacterial drug produced by Streptomyces tenebrarius. It acts primarily by disrupting protein synthesis, leading to altered cell-membrane permeability, progressive disruption of the cell envelope, and eventual cell death. The drug has in vitro activity against Gram-negative bacteria, including P. aeruginosa. It is bactericidal in vitro at peak concentrations equal to or slightly greater than the minimum inhibitory concentration.
In two identically designed, double-blind, randomized, placebo-controlled, parallel-group, 24-week studies, a total of 258 patients received tobramycin inhalation solution therapy on an outpatient basis using a PARI LC Plus nebulizer along with a DeVilbiss Pulmo-Aide compressor. Subjects who were less than 6 years of age, had a baseline creatinine level of greater than 2 mg/dL, or had B. cepacia isolated from sputum were excluded from the trial.
In each study, patients treated with tobramycin inhalation solution experienced significant improvement in pulmonary function. In the first study, improvement was demonstrated in the tobramycin inhalation solution group by an average increase in FEV1 percent predicted of approximately 11% relative to baseline (week 0) during 24 weeks compared with no average change in placebo patients. In the second study, patients treated with tobramycin inhalation solution had an average increase of approximately 7% compared with an average decrease of about 1% in placebo patients.
Patients treated with tobramycin inhalation solution were hospitalized for an average of 5.1 days compared with an average of 8.1 days for placebo patients. In addition, patients treated with tobramycin inhalation solution required an average of 9.6 days of parenteral anti-pseudomonal antibiotic treatment compared with 14.1 days for placebo patients.
Sources: Pipeline Review; December 3, 2014; and Kitabis Pak Prescribing Information; August 2014.