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CURATEK's TOPICAL METROGEL (METRONIDAZOLE) GETS ORPHAN DESIGNATION

Executive Summary

CURATEK's TOPICAL METROGEL (METRONIDAZOLE) GETS ORPHAN DESIGNATION as treatment for acne rosacea, the company announced March 9. The firm estimates that approximately 140,000 patients in a given year suffer from acne rosacea, or "adult acne," a chronic inflammation of the facial skin accompanied by dilated or enlarged blood vessels. Describing the orphan disease, Curatek noted that it causes the nose to become red and enlarged "in extreme cases," a condition called rhinophyma. The company is a privately held company based in Elk Grove Village, Illinois. In a press statement, Curatek said it "specializes in the development and marketing of new ethical pharmaceutical products for dermatology and other therapeutic areas." Curatek filed its NDA for MetroGel in late 1987. The company said clinical studies, which have been completed, showed the drug to be "safe and effective in the treatment of rosacea, including cases where other drugs had failed." To date the most common treatment for rosacea has been the use of oral antibiotics to reduce inflammatory symptoms, Curatek noted. Metronidazole, a synthetic antibacterial, is off patent and currently available only in oral and I.V. form. The leading brand, Searle's Flagyl, is indicated for several types of infections, including anaerobic bacterial infections, amebiasis, and trichomoniasis. Upon approval, Curatek's topical MetroGel will receive seven years of exclusive marketing for the acne rosacea indication under the Orphan Drug Act.

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