
Breakthrough Cystic Fibrosis Drug Utilizes DeVilbiss Pulmo-Aide By Sunrise
07:59 p.m Feb 19, 1998 Eastern
CARLSBAD, Calif.--(BW HealthWire)--Feb. 19, 1998--Sunrise Medical (NYSE:SMD) announced today that the Food and Drug Administration (FDA) recently granted marketing clearance for a breakthrough drug designed for use with the DeVilbiss Pulmo-Aide(r) compressor, manufactured by Sunrise. The innovative new drug TOBI(tm) (Tobramycin Solution for Inhalation), developed by PathoGenesis Corp., is indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa.
"TOBI is a significant advance in treating people with cystic fibrosis," said Robert J. Beall, Ph.D., president and chief executive officer of the Cystic Fibrosis Foundation (CFF). "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 hospitalization. TOBI is the first FDA-approved antibiotic solution for inhalation to treat people with CF." Cystic Fibrosis is the most common life-threatening inherited disease in the United States, affecting about 30,000 children and adults.
"TOBI is specifically formulated for inhalation using a DeVilbiss Pulmo-Aide compressor," said Maryellen Thielen, spokesperson for PathoGenesis Corp. "The Pulmo-Aide was chosen to administer TOBI in our clinical trials of the drug. Six-month clinical trial data indicated improved and maintained lung function, fewer days in the hospital and fewer days requiring anti-pseudomonal antibiotics."
"The evidence we've seen gives us every reason to believe this medication is going to have a significant impact on the treatment of cystic fibrosis," said Rich Kocinski, vice president of product management for Sunrise Medical's respiratory products division. "PathoGenesis intends for this drug to be aerosolized using a DeVilbiss Pulmo-Aide compressor because of the performance it has delivered to patients for more than 30 years."
Sunrise Medical designs, manufactures and markets medical products used in homecare and extended care settings that address the recovery, rehabilitation and respiratory needs of the patient. (See also: http://www.businesswire.com)
Copyright 1998, Business Wire
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