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FDA approves TOBI Podhaler for cystic fibrosis patients with infection

The FDA approved this week tobramycin inhalation powder for the management of Pseudomonas aeruginosa infection in patients with cystic fibrosis.

The tobramycin inhalation powder (TOBI Podhaler, Novartis) is delivered through a plastic, hand-held inhaler device. The powder is inhaled twice daily using the device for 28 days. Patients should then stop the inhaled tobramycin therapy for 28 days before resuming again, according to an FDA press release.

The drug’s effectiveness was established in a study of 95 pediatric and adult patients with cystic fibrosis. All patients were aged 6 years or older and had P. aeruginosa infection. Patients were randomly assigned to receive either tobramycin inhalation powder or a placebo for the first 28 days of the study. All patients then received treatment with tobramycin inhalation powder for the remainder of the study.

Patients treated with tobramycin inhalation powder experienced a statistically significant increase of 12.5% in forced expiratory volume in 1 second (FEV1) compared with 0.09% in patients treated with placebo.

Common adverse effects reported in patients treated with tobramycin inhalation powder during the clinical studies included cough; coughing up of blood; lung disorder; shortness of breath; fever; mouth and throat pain; changes in voice volume or quality; and headache.

Cystic fibrosis is a genetic disease that affects about 30,000 pediatric and adult patients in the United States.

For more information: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm345123.htm.