MONDAY, March 25 (HealthDay News) -- The TOBI Podhaler (tobramycin inhalation powder) has been approved by the U.S. Food and Drug Administration to treat cystic fibrosis patients infected with Pseudomonas aeruginosa, a bacterium that can damage the lungs.
The powder, delivered via a plastic, handheld inhaler device, is inhaled twice daily for 28 days. Patients are then expected to stop TOBI Podhaler therapy for 28 days before resuming again, according to an FDA news release.
The TOBI Podhaler was evaluated in clinical trials involving 95 adults and children 6 years and older with cystic fibrosis. The most common side effects included cough, coughing up blood, shortness of breath, fever, mouth and throat pain, changes in voice, and headache.
"Today's approval broadens the available delivery mechanism options for patients with cystic fibrosis who require treatment for Pseudomonas aeruginosa," Edward Cox, M.D., M.P.H, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, said in a statement. "This product is the first dry powder antibacterial drug delivered with a handheld dry powder inhaler."
The antibiotic inhaler is marketed by Novartis, based in East Hanover, N.J.