Barrier Therapeutics Gets 'Not Approvable' Letter for Zimycan

The FDA has issued Barrier Therapeutics a "not approvable" letter for Zimycan, saying the firm's new drug application for the pediatric dermatitis treatment contained insufficient safety data.

The agency based its decision on a percutaneous absorption study, which, according to the not approvable letter, was deemed inadequate because it used a different grade of petrolatum than that used in Barrier's pivotal clinical studies for Zimycan (miconazole nitrate/zinc oxide/white petrolatum ointment). The absorption study was intended to characterize the systematic exposure to miconazole in infants.

The company noted that the grades of petrolatum used in the absorption study and the pivotal studies met the same USP specifications, and that the absorption study concluded there was minimal systematic absorption of miconazole in infants.

"The company stands fully behind the safety profile of this 0.25 percent concentration of miconazole," Barrier CEO Geert Cauwenbergh said. "Barrier will continue discussions with the agency and is looking at all available options. We believe that one option is to conduct a second percutaneous absorption study using the current product."

Barrier is seeking approval for Zimycan as a treatment for diaper rash complicated by candidiasis, a fungal infection.