The FDA ( Food and Drug Administration ) has approved Tobi Podhaler ( Tobramycin inhalation powder ) for the management of cystic fibrosis patients with Pseudomonas aeruginosa, a bacterium that causes lung infections.
Cystic fibrosis is a genetic disease that affects about 30,000 pediatric and adult patients in the United States. Cystic fibrosis 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 like Pseudomonas aeruginosa to grow and cause a chronic lung infection that, over time, can severely damage the lungs. Many patients with cystic fibrosis 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 Pseudomonas 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.
Tobi Podhaler’s effectiveness was established in a study of 95 pediatric and adult patients with cystic fibrosis. All patients were 6 years of age or older and infected with Pseudomonas aeruginosa. Patients were randomly assigned to receive Tobi Podhaler or a placebo for the first 28 days of the study. All patients then received treatment with Tobi Podhaler for the remainder of the study.
The study was designed to determine the improvement in lung function by measuring the change in forced expiratory volume in one second ( FEV1 ). Patients treated with Tobi Podhaler experienced a statistically significant increase of 12.5% in FEV1 compared to 0.09% in patients treated with placebo. Additional data supporting safety and effectiveness were available from other studies enrolling 487 patients.
Common side effects reported in patients treated with Tobi Podhaler during the clinical studies included cough, including a cough that produces phlegm or mucus; coughing up of blood ( hemoptysis ); lung disorder; shortness of breath; fever; mouth and throat pain; changes in voice volume or quality ( dysphonia ); and headache. ( Xagena )
Source: FDA, 2013