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Flonase: Allergies
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The data showed twice the number of patients preferred NASONEX, which is scent-free and alcohol-free, to Flonase when asked to consider the product's attributes of scent/odor, immediate taste and after-taste. Efficacy was not measured. Researchers, led by Eli O. Meltzer, M.D. of the Allergy and Asthma Medical Group & Research Center in San Diego and lead author of the study, evaluated 100 patients using a double-blind, cross-over method, which exposed subjects to both treatments within 30 minutes of one another.
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The patent covering Flonase ® expired in 2004, taking into account an extension for pediatric exclusivity. Flonase ® is an intranasal corticosteroid spray that helps reduce inflammation and relieves the nasal symptoms associated with seasonal and perennial allergic and perennial non-allergic rhinitis.
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These claims and presentations are misleading because they suggest that Flonase is superior to Nasonex for the treatment of seasonal allergic rhinitis symptoms, when this has not been demonstrated by substantial evidence or substantial clinical experience. The reference cited' to support this claim does not provide substantial evidence for the following reasons. First, the study design raises multiplicity issues. It was designed as a placebo-controlled trial comparing Nasonex to placebo; the active comparison was not clearly planned. It is therefore difficult to determine exactly what significance level should be attached to that comparison. Second, the study was not replicated. In general, a claim of superiority, like other claims under the Act, should be based on comparisons of the two drug products in two adequate, well-designed, head-to-head clinical trials. FDA is not aware of substantial evidence or substantial clinical experience demonstrating that Flonase is superior to Nasonex. If you have additional data to support such claims, please submit them to FDA for review.
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