HHS NEWS

U.S. Department of Health and Human Services




P97-46                        FOOD AND ADMINISTRATION

For Immediate Release         Susan M. Cruzan: 301-827-6242

December 22, 1997             

                              Consumer Inquires: 800-532-4440

FDA Approves Inhaled Antibiotic for Management Of Cystic Fibrosis Patients

The Food and Drug Administration today has announced approval of the first inhaled antibiotic for patients with cystic fibrosis. The new product, tobramycin solution for inhalation (Tobi) is used to suppress pseudomonas aeruginosa in the airways of patients with cystic fibrosis. Pseudomonas aeruginosa is a dangerous microorganism that affects the lungs or respiratory system of most of the 30,000 cystic fibrosis patients in the United States.

Cystic fibrosis is an inherited condition that causes thick mucous secretions in the lungs, resulting in severely diminished lung function and chronic lung infections. Tobramycin, which was first approved in l975 in injection form was reformulated for inhalation to reduce side effects associated with systemic therapy.

The new form of the antibiotic was designated as an orphan drug and will receive incentives under the Orphan Drug Act of l983. It was approved in less than 6 months under an accelerated procedure of the Prescription Drug User Fee Act (PDUFA), the agency's user fee program.

"This is an important new therapy for cystic fibrosis patients," said Lead Deputy Commissioner Michael A. Friedman, M.D. "It also shows the benefits of FDA's Orphan Program and demonstrates the effectiveness of our fast track procedures for medicines for serious diseases."

The new formulation of tobramycin was proven safe and effective in two placebo-controlled trials of about 500 patients with the chronic condition. The trials demonstrated improvement in lung function and reduction of the bacteria in sputum. The drug was administered, often in combination with other standard therapies, in a regimen of 28 days on drug and 28 days without drug therapy to reduce the potential for drug resistance.

Side effects reported in clinical trials included voice alteration and tinnitus (ringing in the ears).

Tobi will be marketed by PathoGenesis Corporation of Seattle, Washington.

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