Powder Tobramycin Okayed for Cystic Fibrosis Lung Infections

Disclosures

March 22, 2013

The US Food and Drug Administration (FDA) approved a tobramycin inhalation powder (TOBI Podhaler, Novartis) for treating patients with cystic fibrosis (CF) whose lungs are infected with the bacterium Pseudomonas aeruginosa, the agency announced today.

P. aeruginosa infections easily develop in the excess mucus accumulating in the lungs of patients with CF, according to the FDA. One antibiotic remedy in the past has been tobramycin inhalation solution (TOBI, Novartis), on the market since 1997. It is delivered through a nebulizer. In contrast, tobramycin inhalation powder (TIP) is delivered through a hand-held, pocket-sized inhaler.

"Today's approval broadens the available delivery mechanism options for patients with cystic fibrosis who require treatment for P. aeruginosa," said Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research in a press release. "This product is the first dry powder antibacterial drug delivered with a handheld dry powder inhaler."

An FDA advisory panel last September voted 13 to 1 to recommend approval of TIP even though FDA staff had questioned the drug's effectiveness in helping patients with CF breathe better.

In its press release today, the FDA said the efficacy of TIP was established in a clinical trial involving 95 patients with CF who were 6 years of age and older and infected with P. aeruginosa. The study attempted to determine gains in lung function by measuring the change in forced expiratory volume in one second (FEV1). For patients receiving TIP, FEV1 rose a statistically significant 12.5%. Patients given a placebo experienced a 0.09% gain. Other studies supported the effectiveness as well as the safety of the drug, according to the FDA.

Common adverse events that surfaced in the studies include coughs producing phlegm or blood, lung disorder, shortness of breath, fever, mouth and throat pain, changes in voice volume or quality, and headache.

More information about today's FDA announcement is available on the agency's Web site.

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