FDA Approves Vusion
Vusion Approved - Barrier Therapeutics, Inc. - Treatment for Diaper Dermatitis Complicated by Candidiasis
February 16, 2006 - The FDA has approved Barrier Therapeutics, Inc., Vusion ointment for the treatment of diaper dermatitis complicated by candidal infection in infants 4 weeks and older. It is estimated that over 40% of cases of "diaper rash" are complicated by yeast infection. Current treatments include antifungal creams, topical corticosteroids, and combination products.
Vusion is the first FDA approved medication for this condition. It is a steroid-free ointment which contains miconazole nitrate 0.25%, zinc oxide, and white petrolatum. In Phase III clinical trials, including 236 children in 20 sites across the US and Latin America, double the number of patients receiving Vusion achieved clearance of yeast and dermatitis 14 days after treatment. Statistically significant improvement was seen as early as 3 days into treatment. At the end of the treatment phase at day 7, the average reduction in severity score as assessed by the Diaper Dermatitis Severity Score was 72% in patients treated by Vusion compared to 25% with vehicle alone.
Posted: February 2006
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- Barrier Therapeutics Receives Not Approvable Letter From the FDA for Zimycan - May 25, 2005
- Barrier Therapeutics Submits Amendment to NDA for U.S. Regulatory Approval of Zimycan - November 29, 2004
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