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| |  Tobi Cleared For Lung Infection In Cystic Fibrosis Patients SEATTLE, WA -- December 23, 1997 – The United States Food and Drug Administration (FDA) has granted marketing clearance to PathoGenesis Corp.’s Tobi(TM) (tobramycin solution for inhalation), a new formulation of the antibiotic tobramycin, specifically designed for inhalation and indicated for the management of cystic fibrosis (CF) patients with Pseudomonas aeruginosa. "Tobi is a significant advance in treating people with cystic fibrosis," said Robert Beall, Ph.D., president and chief executive officer of the Cystic Fibrosis Foundation. "By an early age, P. aeruginosa, the bacteria that causes 80 percent of CF lung infections, becomes the dominant pathogen in the lungs. "These infections make it difficult to breathe and often cause hospitalisation. Tobi is the first FDA-approved antibiotic solution for inhalation to treat people with CF." CF is the most common life-threatening inherited disease in the U.S., affecting about 30,000 children and adults. Two double-blind, randomised, placebo-controlled clinical trials were conducted for 24 weeks at cystic fibrosis centres across the U.S. A total of 520 cystic fibrosis patients ages six to 63 with P. aeruginosa lung infections participated in the Phase III trials. Patients were divided into two groups -- those receiving standard CF therapy and those receiving Tobi plus standard CF therapy. Tobi-treated patients received drug in repeated cycles of 28-days on drug, 28-days off drug. Compared with placebo plus standard CF therapy, six-month clinical trials of Tobi showed: -- Improved and maintained lung function: Tobi-treated patients demonstrated a significant improvement in lung function compared to those receiving standard CF therapy. -- Fewer days in the hospital: On average, Tobi-treated patients were hospitalised three fewer days than patients receiving standard CF therapy -- 5.1 days for Tobi patients, compared to 8.1 days for placebo patients. -- Fewer days requiring anti-pseudomonal antibiotics: On average, Tobi-treated patients required 4.4 fewer days of intravenous anti-pseudomonal therapies than patients receiving standard CF therapies -- 9.7 days for Tobi patients, compared to 14.1 days for placebo patients. "The results from the clinical trials were excellent -- Tobi maintained improvement in pulmonary function over six months," said Bonnie Ramsey, M.D., CF Center director, Children's Hospital and Regional Medical Center in Seattle, and principal investigator of the Tobi clinical trials. "Patients typically lose two percent of lung function annually, so this level of improvement is a significant step forward in managing the disease." Clinical studies show Tobi was well tolerated by patients. More Tobi-treated patients experienced hoarseness (13 percent versus seven percent in placebo patients) and ringing in the ears (three percent versus none of the placebo patients). All episodes of ringing in the ears were temporary and resolved without stopping the Tobi treatment regimen. Bronchospasm also may occur with inhalation of Tobi. Caution should be used with patients receiving Tobi who are known or suspected to have kidney, hearing or neuromuscular problems; are pregnant or become pregnant; or are receiving intravenous aminoglycoside treatment. Safety and effectiveness were not studied in patients under the age of six years, patients with lung function of less than 25 percent or more than 75 percent of predicted normal levels, or patients colonised with Burkholderia cepacia. Treatment with Tobi did not affect the susceptibility of the majority of P. aeruginosa isolates during the six-month studies. Tobi therapy resulted in a significant reduction in P. aeruginosa density in sputum (phlegm) during the on-drug periods. Sputum bacterial density returned to baseline during the off-drug periods. Reductions in sputum bacterial density were smaller in each successive cycle. Each ready-to-use ampule of Tobi contains 300 milligrams of tobramycin in a five millilitre solution. Tobi is aerosolised and administered using a Pari LC Plus(TM) reusable nebulizer and a DeVilbiss Pulmo-Aide(R) compressor. It is inhaled twice daily and requires about 10 to 15 minutes per treatment. The Tobi treatment regimen consists of repeated cycles of 28-days on drug, followed by 28-days off drug. Cystic fibrosis is characterised by the production of unusually thick, sticky mucus that typically blocks the airways of the lungs. Consistent production of mucus prevents clearance of bacteria, allowing them to colonise and multiply. As a result, chronic infection and inflammation occur, causing people with cystic fibrosis to experience persistent coughing, sputum expectoration and wheezing. The continuous inflammation and infection lead to lung damage and destruction, and ultimately, death. CF can also affect other areas of the body, including the pancreas and sweat glands.
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