MERRELL DOW NICORETTE ANTI-SMOKING Rx CHEWING GUM TRADE SHIPMENTS

Executive Summary

MERRELL DOW NICORETTE ANTI-SMOKING Rx CHEWING GUM TRADE SHIPMENTS will begin in the last half of February. The company anticipates that the product will be widely available at the retail level by March 1. The average whsle. price for a box of 96, 2 mg pieces of the gum will be $14.21. The product is expected to be priced at the retail level at about $20 per box. Nicorette received FDA approval on Jan. 13. Merrell Dow plans to hold a press conference on the product in NYC on Jan. 24. According to FDA-approved labeling, Nicorette is indicated as a "temporary aid to the cigarette smoker seeking to give up his or her smoking habit while participating in a behavioral modification program under medical surpervision." The labeling states that "the efficacy of Nicorette as an aid to smoking cessation was demonstrated in clinical studies which showed that Nicorette gum, in comparison to control chewing gums, increased the likelihood of smoking cessation among participants in behavior modification programs. As used in the context of this labeling, behavioral modification refers to supervised programs of education, counseling and psychological support. The efficacy of Nicorette use without concomitant participation in a behavioral modification program has not been established." According to the package insert, smokers most likely to benefit from Nicorette use are those "who have a high physical type dependence on nicotine." FDA approved Nicorette after a 34-month review; the NDA was filed in March 1981. The U.S. data submitted by the firm included studies involving over 100 MDs and 3,000 patients. The product was recommended for approval last June by FDA's Drug Abuse Advisory Cmte. That group also urged in October that Nicorette be marketed without DEA scheduling controls. Merrell Dow licensed Nicorette from AB Leo (Sweden). The Swedish firm is manufacturing the product for Merrell Dow.