To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Tobi Approved In Canada For Cystic Fibrosis URL: http://www.pslgroup.com/dg/FD06E.htm Doctor's Guide May 11, 1999
MONTREAL, QC -- May 11, 1999 -- Health Canada's Therapeutic Products Programme has approved PathoGenesis Canada Ltd.'s Tobi(TM) (tobramycin solution for inhalation) for the management of cystic fibrosis (CF) patients with chronic pulmonary Pseudomonas aeruginosa infections. P. aeruginosa bacteria are responsible for nearly 90 percent of all lung infections in CF patients. Tobi is the first antibiotic specifically designed for inhalation approved in Canada. "Tobi could represent an important therapeutic option for cystic fibrosis patients. Chronic lung infections are extremely common in these patients. These infections have a serious impact on lung function and contribute to the overall deterioration of CF patients," said Dr. André Cantin, professor of medicine and Cystic Fibrosis Clinic director, University of Sherbrooke. The Canadian Cystic Fibrosis Foundation estimates that 3,000 Canadians live with CF. One in 2,500 children born in Canada has cystic fibrosis. Cystic fibrosis is an incurable hereditary disease that mainly affects the lungs and the digestive system. It is characterised by the production of unusually thick and sticky mucus, which prevents the clearance of bacteria, and by frequent and prolonged pneumonia and weight loss in spite of excessive appetite. It is estimated that 95 percent of cystic fibrosis patients eventually die of respiratory failure after many years of deteriorating lung function caused by recurring respiratory infections. Important progress has been made in the treatment of cystic fibrosis since the disease was first identified in the 1930s. According to 1997 statistics from the Canadian Cystic Fibrosis Foundation, the median survival rate of CF patients is 32.5 years. Just over a decade ago, most CF patients were dying in their mid-20s. Current treatments include bronchodilators, steroidal anti-inflammatories, mucolytics (used to break up mucus), bronchial constriction prophylactics, anti-pseudomonal agents and airway clearing techniques such as postural drainage. "With a better understanding of the disease and the development of new treatments, the future of people with cystic fibrosis is becoming brighter," Dr. Cantin said. The active ingredient in Tobi is tobramycin, a member of the aminoglycoside antibiotic class. Tobi comes in 5mL ampoules containing 300mg of tobramycin with no potentially toxic preservatives. It is administered twice-daily using a PARI LC Plus(TM) reusable nebulizer and a DeVilbiss Pulmo-Aide(R) air compressor. Patients take Tobi in cycles of 28 days on the drug and 28 days off the drug. In clinical trials, Tobi was generally well-tolerated. Hoarseness and ringing in the ears were the only side-effects occurring at a higher rate in the treatment group versus the placebo group. All episodes of ringing in the ears were transient in nature and did not cause the patients to abandon therapy. In two six-month studies published in the New England Journal of Medicine, Tobi was shown to significantly benefit CF patients suffering from P. aeruginosa lung infections. A total of 520 patients were randomly assigned to receive either 300mg of inhaled Tobi or an inhaled placebo. Both groups also received standard treatments for the management of cystic fibrosis including other antibiotics. Tobi was administered in three on and off 56-day cycles. Patients received Tobi for a period of 28 days and were then taken off the treatment for a period of 28 days. This cycle was repeated three times. Key findings include: -- 10 percent average increase in lung function in the Tobi group versus two percent decline in placebo group -- Tobi-treated patients were 26 percent less likely to be hospitalised -- Tobi-treated patients were, on average, hospitalised for 37 percent less time than patients in the placebo group (5.1 days in treated group versus 8.1 days in placebo group) -- Tobi-treated patients were 36 percent less likely to require intravenous anti-pseudomonal therapies (9.7 days in treated group versus 14.1 days in placebo group) Related Links: Tobi, PathoGenesis Canada Ltd. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.