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RHONE-POULENC RORER's NASACORT Rx NASAL INHALER APPROVED

Executive Summary

RHONE-POULENC RORER's NASACORT Rx NASAL INHALER APPROVED by FDA for the treatment of allergic rhinitis on July 11, the company announced July 15. The active ingredient of Nasacort -- triamcinolone -- is the same as in Rorer's metered-dose inhaled astha medication Azmacort. Triamicinolone is also marketed by Rugby Labs in a 0.1% ointment and cream as a topical corticosteroid. Nasacort is indicated for "seasonal and perennial allergic rhinitis." The product is approved for rhinitis in adults and children over 12 years old. Nasacort is to be administered once per day, two puffs of spray per nostril. A 10 gm metered-dose Nasacort inhaler provides 100 doses at 55 mg per dose. Nasacort is rated "3C" (new formulation with little or no therapeutic gain over already marketed drugs) by FDA. FDA's review of the once-a-day nasal formulation of triamicinolone acetonide was conducted by the agency's Pilot Drug Evaluation Staff because the drug is an inhaled corticosteroid. Rhone-Poulenc Rorer has agreed to conduct Phase IV postmarketing studies on Nasacort. In a June 21 letter to FDA's Pilot Drug Evaluation Staff, the company committed to: "a research program with a goal of achieving unique particle size distribution profiles for Azmacort and Nasacort"; "a new design and analysis methodology for dose-response and therapeutic equivalence studies"; "a dose-response study with the marketed Nasacort formulation"; and "a therapeutic equivalence trial comparing the new formulation to the marketed formulation." The company said it plans a "major U.S. launch of the product." Nasacort will be introduced to physicians on Aug. 19 and detailed by RPR's 900-person sales force. Pricing, advertising and promotional plans have yet to be announced. FDA's approval letter for Nasacort notes that the company and the agency will work together on creating an appropriate introductory campaign for the drug. "As a reflection of our mutual understanding of the importance of initial promotional campaigns on physicians' use of a new drug," the approval letter states, "we note your commitment to work with us and with the Division of Drug Advertising and Labeling on this advertising program to develop an introductory campaign satisfactory to all concerned." Rorer submitted the NDA for Nasacort on Jan. 22, 1988 and resubmitted an application on Dec. 22, 1988. Rorer filed the Nasacort NDA electronically in conjunction with Research Data Corp.

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