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Executive Summary

GLAXO's CUTIVATE (FLUTICASONE PROPIONATE) OINTMENT AND CREAM APPROVED as a twice daily mid-potency treatment for inflammation and pruritis associated with corticosteroid-responsive dermatoses. Cutivate ointment 0.005% was approved Dec. 14; Cutivate cream 0.05% was approved Dec. 17. Glaxo filed the NDAs for topical fluticasone propionate on Oct. 26, 1989. FDA rated the drug "1C" (new molecular entity with little or no therapeutic gain over already marketed treatments). The drug had been "approvable" since October. Glaxo plans to launch Cutivate in "mid-1991" in 15 gm and 30 gm tubes. Pricing has not yet been determined. Cutivate will flesh out the line of corticosteroids marketed by Glaxo Dermatology, which also includes the low-potency Alcovate (alclometasone dipropionate 0.05% cream and ointment), the high-potency product Temovate (clobetasol propionate 0.05% cream and ointment) and the broad-spectrum antifungal cream Oxistat (oxiconazole nitrate 1%). Glaxo Dermatology, staffed by 51 sales reps, was established in 1985 as a specialized marketing division in preparation for the launch of Temovate in 1986. Alcovate was introduced in Janauary 1987 and Oxistat in May 1989. Division sales rose 30% in the last fiscal year, Glaxo noted. Approved labeling states that in clinical trials, the total number of adverse reactions associated with Cutivate ointment was "approximately 4%," and were "mild [and] usually self-limiting." The adverse reactions consisted "primarily of pruritis, burning, hypertrichosis, increased erythema, hives, irritation and lightheadedness." The incidence of each of these adverse reactions was less than 1%. Glaxo submitted data in the NDA on more than 950 patients for fluticasone propionate cream and more than 2,500 patients for Cutivate ointment. Labeling says that the compound "should not be used in the treatment of rosacea and perioral dermatitis." Other labeling precautions warn of the potential, found among all systemically absorbed topical corticosteroids, for hypothalamic-pituitary-adrenal (HPA) axis suppression, and note that the drug's "safety and effectiveness in children and infants has not been established." Glaxo maintains in introductory material that Cutivate shows a "low incidence of HPA axis suppression." The active ingredient is also being studied by Glaxo in a topical formulation as part of its next generation of asthma products. The asthma product will be called Flixotide. Labeling for the dermatological states that in clinicals, fluticasone propionate at 10 times the actual concentration "did not supress plasma cortisol in any of six patients but did moderately suppress 24-hour urinary free cortisol levels in two of six patients when used at a dose of 30 gm per day for a week in patients with psoriasis and eczema." In a second study, the drug "caused a minimal depression of a.m. plasma cortisol levels in three of 12 normal volunteers when applied at doses of 50 gm per day for 21 days." Levels "returned to normal within the first week" of discontinuing the drug. In the summary basis of approval, FDA says Glaxo has agreed to submit the results of a Phase IV vasoconstriction study using the marketed ointment formulation.

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