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TOBI Podhaler Approved for Bacterial Lung Infection in CF Patients

Inhalation device contains dry-powder tobramycin (Mar. 22)

The FDA has approved TOBI Podhaler (tobramycin inhalation powder, Novartis) for the management of patients with cystic fibrosis (CF) who are infected with Pseudomonas aeruginosa, a bacterium that causes lung infections.

CF is a genetic disease that affects approximately 30,000 pediatric and adult patients in the U.S. The disease causes the body to produce thick, sticky mucus that builds up in the lungs and blocks airways. The buildup of mucus makes it easy for bacteria such as P. aeruginosa to grow and cause a chronic lung infection that, over time, can severely damage the lungs. Many patients with CF are treated with antibiotics using a nebulizer machine.

TOBI Podhaler — a plastic, handheld inhaler device — contains a dry-powder formulation of tobramycin, an antibiotic used to treat P. aeruginosa infection. The powder is inhaled twice daily using the Podhaler device for 28 days. Patients should then stop TOBI Podhaler therapy for 28 days before resuming again.

The effectiveness of the device was established in a study of 95 pediatric and adult patients with CF. All of the patients were 6 years of age or older and were infected with P. aeruginosa. The patients were randomly assigned to receive treatment with the TOBI Podhaler or placebo for the first 28 days of the study. All of the patients were then treated with the TOBI Podhaler for the remainder of the study.

The trial was designed to determine improvement in lung function by measuring the change in the forced expiratory volume in 1 second (FEV1). The patients treated with the TOBI Podhaler showed a statistically significant increase of 12.5% in the FEV1 compared with an increase of 0.09% in patients treated with placebo. Additional data supporting the safety and efficacy of the inhalation device were available from other studies that enrolled a total of 487 patients.

Common adverse effects of treatment with the TOBI Podhaler during clinical studies included cough that produces phlegm or mucus; coughing up of blood (hemoptysis); lung disorders; shortness of breath; fever; mouth and throat pain; changes in voice volume or quality (dysphonia); and headache.

Source: FDA; March 22, 2013.

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