FDA Approves Vusion Ointment
FDA Approves Vusion Ointment for the Treatment of Diaper Dermatitis Complicated by Candidiasis
The First and Only Product Specifically Developed For This Indication
PRINCETON, N.J., February 16, 2006-Barrier Therapeutics, Inc., a pharmaceutical company developing and commercializing products in the field of dermatology, today announced that the U.S. Food and Drug Administration (FDA) has approved 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.
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.
"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, Ph.D., 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."
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.
Mary Spraker, M.D., a pediatric dermatologist and associate professor in the department of dermatology and pediatrics at Emory University in Atlanta, assisted in designing the pivotal Vusion Phase 3 study protocol. Dr. Spraker explained, "There is solid data demonstrating the efficacy and safety of Vusion on infants with DDCC. With the product now approved for the U.S. market, pediatricians and dermatologists can prescribe a treatment specifically meant for the condition that it was designed for and that is well tolerated for use on infants. Doctors are no longer reliant on prescribing antifungal agents intended for adults that have not been tested on children with diaper dermatitis complicated by candidiasis."
In the pivotal Phase 3 clinical study conducted by Barrier, 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.
"We are very excited to be able to address this unique patient group and are well positioned to move forward with the anticipated launch of Vusion into the U.S. market," said Al Altomari, Chief Commercial Officer. "We have already begun implementing our strategic plans by increasing the sales force to sixty territories in support of this important new Barrier product. We anticipate the first shipment of Vusion will be made in the second quarter of this year."
Posted: February 2006