Executive Summary

CURATEK METROGEL TOPICAL METRONIDAZOLE LAUNCH is under way. The company received approval on Nov. 22 for MetroGel in the treatment of rosacea, a chronic acne-like facial inflammation accompanied by dilated or enlarged blood vessels. FDA gave the prescription antiprotozal/antibacterial product a 3B classification, a new formulation representing a modest therapeutic gain. Curatek filed its NDA for MetroGel in late 1987. Metrogel (7.5% metronidazole) gel will be available at an AWP price of $12.30 per one ounce aluminum tube, Curatek said. With the approval, MetroGel gains seven years of marketing exclusivity for the orphan indication. Curatek estimates that approximately 150,000 patients a year suffer from rosacea. "In advanced cases... the nose becomes red and enlarged, a condition known as rhinophyma," the firm noted in a Nov. 30 release announcing the approval. "In the past, the most common treatment for the disease has been with oral antibiotics, which may be ineffective or associated with adverse reactions such as allergies, nausea and genital infections," Curatek said in the release. MetroGel has demonstrated safety and efficacy in clinical trials, including situations where treatment with oral antibiotics had failed, the company added. Metronidazole is off patent and was previously available only in oral and I.V. formulations. The approved labeling for MetroGel states that the drug "is indicated for topical application in the treatment of inflammatory papules, pustules, and erythema of rosacea." The labeling instructs that MetroGel should be applied twice daily and notes that "significant therapeutic results should be noticed within three weeks." The precautions section of the labeling warns that MetroGel "has been reported to cause tearing of the eyes [and] therefore, contact with the eyes should be avoided." This section also states that although MetroGel is topically applied, that it should be kept in mind that oral metronidazole has been reported to increase the anticoagulant effect of coumarin and warfarin. Curatek is a privately-held company located in Elk Grove Village, Illinois. The firm says it "specializes in the development and marketing of new ethical pharmaceutical products for dermatology and other therapeutic areas."