Vusion Ointment
Generic Name: miconazole nitrate, zinc oxide and white petrolatum ointment
Date of Approval: February 16, 2006
Company: Barrier Therapeutics, Inc.
Treatment for: Diaper Dermatitis Complicated by Candidiasis
 | |||||||||
 Feedback for Vusion
| |||||||||
The U.S. Food and Drug Administration (FDA) has approved Vusion (0.25% miconazole nitrate, 15% zinc oxide and 81.35% white petrolatum) Ointment for the treatment of diaper dermatitis complicated by candidiasis (DDCC) in infants 4 weeks and older.
This inflammatory condition occurs when diaper dermatitis, also known as diaper rash, is complicated with a fungal infection caused by yeast known as Candida. The existence of Candida is readily determined by microscopic evaluation for presence of pseudohyphae or budding yeast. Vusion is the only prescription product approved for the treatment of this condition in the United States.
There are approximately 8 million infants under the age of two in the U.S. It is estimated that diaper dermatitis is observed in approximately one million pediatric outpatient visits each year. Additionally, it is estimated that of all diaper dermatitis cases treated by physicians, more than 40% are complicated by the yeast Candida. Until now, common treatment options have included the use of antifungal products, steroids, and combination products not specifically approved for the treatment of DDCC or for use on infants.
Vusion is a steroid-free formulation that contains the active ingredient miconazole nitrate at a concentration of 0.25%, which directly treats the infection with proven antifungal efficacy. The ointment base for Vusion is comprised of zinc oxide and white petrolatum, which are the main components in most common diaper rash products. In clinical trials, statistically significant improvement was observed in infants with DDCC within three days of treatment with Vusion.
In the pivotal Phase 3 clinical study, more than twice the percentage of patients treated with Vusion achieved the primary endpoint of elimination of the yeast and complete clearing of all signs and symptoms of the disease at day 14, one week after stopping treatment, as compared with patients treated with the vehicle (zinc oxide and petrolatum). At the end of treatment (day 7), the average reduction in the signs and symptoms score, as determined by the Diaper Dermatitis Severity Score, was 72% with Vusion versus 25% with the vehicle ointment. The double-blind, vehicle-controlled study, which was conducted at 20 sites in the United States and Latin America, included 236 children under the age of three years who were diagnosed with DDCC.
Source: Barrier Therapeutics, Inc.
For full prescribing information, please visit the Vusion Ointment website.
 |
Link to Page |  |
Print Page |  |
Email Page |  | Add to List |
More Vusion resources
