Barrier Therapeutics, Inc., a pharmaceutical company developing and commercializing products in the field of dermatology, has been issued a not approvable letter dated May 24, 2005 for its NDA for Zimycan (0.25% miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum ointment) for the treatment of diaper dermatitis complicated by candidiasis by the US FDA.

The FDA action is based on the insufficient information to characterize the systemic exposure to miconazole in infants. Characterization of systemic exposure to miconazole is a component of the safety evaluation of the product.

The Agency indicated that the percutaneous absorption study that was in the application was not sufficient since the product tested used a different grade of petrolatum than that used in the pivotal clinical studies. Both grades meet the same USP specifications for petrolatum. The percutaneous absorption study in the application concluded that there was minimal systemic absorption of miconazole.

Zimycan for the treatment of diaper dermatitis complicated by candidiasis, contains miconazole nitrate, which directly treats the infection, while zinc oxide and white petrolatum provide a barrier to keep excessive moisture away from the skin. This moisture contributes to the cause of the Candida infection. 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 US.