The US FDA has approved Barrier Therapeutics' Vusion (0.25% miconazole nitrate, 15% zinc oxide and 81.35% white petrolatum) Ointment. Vusion was specifically formulated 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.
"We are very pleased that the FDA has approved Vusion and we are proud to bring a product to the market that fills a significant need in this important pediatric patient population," commented Geert Cauwenbergh, chairman and CEO of Barrier Therapeutics. "The launch of Vusion will allow us to continue our commercial build out and further execute upon our business strategy," he added.
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 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.
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.