ROANOKE TIMES
Copyright (c) 1996, Roanoke Times
DATE: Sunday, February 11, 1996 TAG: 9602130084
SECTION: NATIONAL/INTERNATIONAL PAGE: A9 EDITION: METRO
DATELINE: WASHINGTON
SOURCE: ASSOCIATED PRESS
Smokers trying to kick the habit can soon try the first nicotine gum ever approved by the Food and Drug Administration for over-the-counter sale.
Nicorette, which helps relieve withdrawal symptoms by providing an alternative source of nicotine without the tar and carbon monoxide of cigarette smoke, has been available by doctor's prescription for 12 years.
The FDA removed the prescription requirement Friday, and manufacturer SmithKline Beecham Consumer Healthcare said the gum will be available for walk-in sale in April.
``According to surveys, 75 percent of smokers would like to quit, but 70 percent won't see a doctor to do so,'' said Jack Ziegler, executive vice president at SmithKline Beecham. ``Making Nicorette available without a prescription will increase access for people who are ready to quit smoking.''
FDA spokesman Jim O'Hara confirmed the approval Friday night, and said that sale of the gum would be restricted to consumers ages 18 and over.
In September, an advisory panel unanimously recommended that the FDA drop its prescription requirement for Nicorette.
Nicorette is marketed in 50 countries. U.S. sales produce revenue of approximately $250 million per year, according to SmithKline.
Company representatives said they plan to market the gum in two kits. The first will be an introductory package, retailing for about $50, that will include a two-week dosage of gum, a program guide and a user tape.
The second kit, about $30, would include gum and program guide.
At an advisory panel hearing last year, SmithKline executives said they would market the gum at a high enough price to discourage impulse buying.
``It's important to remember that Nicorette alone won't make a smoker quit,'' Ziegler said in a press release. ``He or she must decide to quit and stay committed to it.''
LENGTH: Short : 43 linesby CNB