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Positive Phase 3 Data Results Announced for Candida-Associated Diaper Dermatitis
"These Phase III clinical results provide Barrier Therapeutics with a clear path to filing an amendment to our New Drug Application for Zimycan in the U.S.," said Geert Cauwenbergh, Ph.D., Chairman and CEO of Barrier Therapeutics. "Currently there is no treatment specifically developed and approved for Candida-associated diaper dermatitis in the U.S. This means that infants are often treated with drugs that have been developed for adult uses. The formulations of these products are not necessarily suitable for use on infant skin, and the potency of the active ingredient is not adjusted for infant use," he added. "Barrier Therapeutics is proud to be the first Company to have developed a drug specifically aimed at treating this common skin problem in this vulnerable patient group."
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 3 years who were diagnosed with diaper dermatitis that was complicated by the presence of the yeast, Candida. The children were treated for 7 days with either the vehicle, consisting of zinc oxide plus petrolatum, or with Zimycan, Barrier's product consisting of 0.25% miconazole nitrate, an anti- fungal agent, in the zinc oxide petrolatum base. The vehicle used in this study is generally recognized as the standard of care for uncomplicated diaper dermatitis. The primary endpoint was "overall cure" at day 14, one week after the end of treatment. "Overall cure" was defined as eradication of the fungus and complete clearing of all signs and symptoms of the disease.
At the end of treatment (day 7) the average reduction in the signs and symptoms score was 72% with Zimycan versus 25% with the vehicle ointment. Both Zimycan and the vehicle were well tolerated. There were no serious adverse events in either group nor were there adverse events related to treatment in either group. The non-serious adverse events were evenly distributed between the groups and were considered typical in this patient population.
Zimycan is a topical ointment consisting of 0.25% miconazole nitrate, an antifungal agent, in a zinc oxide and petrolatum base. Barrier is developing Zimycan for the treatment of infants with Candida-associated diaper dermatitis, an inflammatory disease in which an infant's diaper rash is complicated with an infection caused by the fungus called Candida. Diaper dermatitis, commonly known as diaper rash, is one of the most common skin conditions in infants and is observed in approximately one million pediatric outpatient visits each year in the United States. The Company believes that more than 40% of all diaper dermatitis treated by a physician involves Candida. In the United States, there currently is no prescription drug approved to treat Candida-associated diaper dermatitis. If and when approved by the FDA, the Company plans to initially market the product in the U.S. to pediatric dermatologists and pediatricians using a contract sales organization under the supervision of a Barrier sales management team. The product has received marketing approval from the Belgian Health Authorities and is the subject of a Mutual Recognition Procedure for approval in the major markets of Europe.
Source: Barrier Therapeutics, Inc.