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Executive Summary

EDGEFIELD's TABMINT SILVER ACETATE OTC SMOKING DETERRENT CHEWING GUM is significantly effective compared to placebo, the firm maintains in a recent study submission to FDA for Category I classification. The study, conducted at the Medical University of South Carolina, reported smoking cessation in 22% (15) of the 68 subjects completing the study using Tabmint, and 7% (6) of the 87 subjects using placebo (p = 0.03). The study concluded that "silver acetate is a deterrent to smoking in the setting of minimal health professional contact in a three week treatment program." Edgefield noted in its submission that the purposes of the study "was to confirm -- or deny -- the results of tests that had previously been made in Europe, which showed effectiveness, but which the advisory panel felt were statistically flawed." The firm said that it expected the study would "confirm the effectiveness of Tabmint chewing gum as a smoking deterrent. The study report showed that of 282 subjects beginning the three week trial, only 155 completed the study -- with a drop out rate of 50% in the silver acetate group and 41% in the placebo group. In a four month follow-up of 98 test subjects, 4.5% of those in the placebo group and 13% in the silver acetate group were still not smoking. The 57 subjects who completed the trial but did not take part in the follow-up were treated as "smokers" in the statistical analysis. Acknowledging the relatively high failure rate with the therapy over the four month follow-up period, Edgefield suggested that labeling for OTC Tabmint recommend occasional use of the gum for up to six months following the initial three-week course of therapy. Edgefield's suggested "instructions for use" would read: "Chew up to 6 tablets daily for 3 weeks -- 1 every 3 to 4 hours as needed -- (chew each tablet for at least 20 or 30 minutes). If you have not stopped smoking, or greatly reduced the number of cigarettes smoked by this time, discontinue treatment. After this period Tabmint may be used occasionally as needed -- not more than 1 or 2 tablets per day -- for up to six months, if helpful in continuing not smoking." The firm also noted that given FDA's "recently expressed desire that the format listed on the package contain all ingredients," package labeling for Tabmint would read: "Active Ingredient, Silver Acetate 6 mg; also contains co-carboxylase, ammonium chloride, sugar, flavor additive, gum base, color." Although "co-carboxylase and ammonium chloride cannot be considered active ingredients . . . there are sound technical reasons for including them in the formula," Edgefield explained. "Their purpose is to enhance the reaction (metallic taste) between the silver acetate and cigarette smoke -- and therefore the effectiveness of the product -- and to inhibit the formation of silver compounds which might accumulate in the body."

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