Zimycan "Not Approvable" Letter Could Mean One-Year Delay In Approval
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA's concerns stem from Barrier Therapeutics' use of a different grade of petrolatum in the absorption study than in clinical trials for the diaper dermatitis agent. The firm says conducting an additional study would take two to four months, plus six months for an agency review.
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Barrier Therapeutics believes it may have to conduct a second absorption study for its antifungal ointment Zimycan following receipt of a "not approvable" letter May 24. Barrier licensed Zimycan (0.25% miconazole, 15% zinc oxide and 81.35% petrolatum) from Johnson & Johnson in 2002. J&J had initially, but unsuccessfully, sought approval as an over-the-counter drug with a general diaper rash claim (1 (Also see "OTC-To-Rx Switch: Barrier Expects Zimycan Trial Data To Boost NDA" - Pink Sheet, 11 Aug, 2004.)). Barrier is seeking a prescription indication for treatment of diaper dermatitis complicated by candidiasis. The company submitted an amendment, which included positive efficacy data, to J&J's original NDA in November 2004. While discussions with FDA are ongoing regarding regulatory options for Zimycan, "one of these options could be an additional percutaneous absorption study, which could take us two to four months to conduct," Barrier Chief Operating Officer Chuck Nomides told investors May 25. "If you add to that an FDA review, which could take up to six months, we could be looking at a year from now for further FDA action," Nomides said. FDA's key concern with the NDA stems from the company's use of a different grade of petrolatum in the absorption study than that used in clinical trials, the exec explained. "The agency said there is insufficient information to characterize the systemic exposure to miconazole in infants," Barrier said. The Princeton, N.J.-based company asserts that despite FDA's concern, both petrolatum grades "meet the same USP specifications." - Lee Szilagyi |