FDA approves asthma drug for patients as young as 4
FDA approves asthma drug for patients as young as 4
Flovent Rotadisk well-tolerated in children
If you delay starting an asthma patient on inhaled corticosteroids, you risk a loss of lung function that can’t be restored. But what if your patient is younger than 11, too young for approved use of inhaled corticosteroids? In the past, your choices were to face irreversible damage or prescribe a drug off-label. Now there’s another option for many of the 4.8 million children suffering from the most common chronic disease of childhood: Flovent Rotadisk, an anti-inflammatory corticosteroid recently approved for children between the ages of 4 and 11.
The drug’s approval by the Rockville, MD-based U.S. Food and Drug Administration comes on the heels of the Bethesda, MD-based National Heart, Lung and Blood Institute’s (NHLBI) updated asthma guidelines. The new guidelines heavily emphasize the inflammatory nature of asthma and the need for long-term control medications that reduce the inflammation. They state that early intervention with inhaled corticosteroids can improve asthma control and normalize lung function and may prevent irreversible airway injury.
The researchers and marketers of Flovent Rotadisk say the drug is a good answer to the NHLBI suggestions. "When it comes to treating children with asthma, it is important to begin treatment with an anti-inflammatory medication as early as possible," says Edwin Bronsky, MD, co-director of the Pediatric Allergy Clinic at the Primary Children’s Hospital in Salt Lake City. "In our studies, Flovent Rotadisk was shown to be effective and well-tolerated in children as young as 4 years of age who have asthma."
Flovent Rotadisk (fluticasone propionate), at doses of 50 and 100 mcg given twice daily, is the first anti-inflammatory corticosteroid medication to be cleared as preventive therapy for young asthma patients. The drug has low absorption into the bloodstream and a high level of anti-inflammatory action that helps improve asthma control and normalize lung function, says Kathy Rickard, MD, director of U.S. Respiratory Medical Affairs for Research Triangle Park, NC-based Glaxo Wellcome, the drug’s marketer. The drug makes breathing easier by reducing the swelling and irritation in the walls of the small air passages in the lungs, and, when used regularly, it may help prevent asthma attacks and alleviate the need for other medications that have significant side effects. It is not indicated for the rapid relief of asthma attacks since the drug does not affect symptoms immediately. Improvement is usually seen within 24 hours of beginning treatment, but it may take one to two weeks to see maximum benefits.
In a 12-week clinical trial of 263 patients ages 4 to 11 who were inadequately controlled on bronchodilators alone, Flovent Rotadisk improved morning peak expiratory flow by 28% at 50 mcg twice daily and 34% at 100 mcg twice daily compared with placebo (11% change). In a second year-long trial of 325 patients ages 4 to 11, the drug improved lung function by the first week of treatment, and the improvement continued for a year compared with patients in the control group. Clinical trials were also done on 1,197 adolescent and adult asthma patients to test appropriate dosing to cover a range of asthma severity, and the drug was found to be effective and well-tolerated.
"One of the best things about Flovent Rotadisk is that it’s more topically potent and works better in reducing inflammation in smaller doses," Rickard says. "It’s a significant benefit that you only have to take the drug twice a day, as opposed to four times with other drugs and that lower doses are highly effective. Twice-a-day dosing minimizes disruption to the child’s daily routine."
Alternative to metered dose
The drug also offers an easy-to-use device that enhances patient compliance. The device, called the Diskhaler, is a flat disk that Rickard likens to the Starship Enterprise designed especially for kids. "You just cock the lever, put the mouthpiece in, and inhale," she says. "There’s nothing to coordinate. It’s also good for adults who can’t use a metered dose inhaler."
Reported side effects among patients in the trials were those common to all inhaled corticosteroids hoarseness, rhinitis, sinusitis, nasal congestion, sore throat, headache, upper respiratory infection but they were mostly mild to moderate in severity and tended to be dose-related, Rickard says. Less than 2% of the patients discontinued participation in the trials because of side effects.
[For more information on Flovent Rotadisk, contact Glaxo Wellcome, P.O. Box 13398, Research Triangle Park, NC 27709. Telephone: (919) 248-2100.]
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