ANSWERS 02/12/1996
T96-10 Ivy Fleischer Kupec
Feb. 12, 1996 (301) 443-3285
FDA APPROVES NICORETTE FOR OTC MARKETING
FDA approved for over-the-counter marketing Nicorette gum,
making it the first smoking cessation aid available without a
prescription for adults. The following can be used to answer
questions:
Based on recommendations of a joint advisory panel
(Nonprescription Drugs and Drug Abuse Advisory Committees) that
met in September 1995, FDA officials approved over-the-counter
status for Nicorette gum (nicotine polacrilex) in both 2 mg and 4
mg strengths. Available in the United States since 1984 by
prescription only, Nicorette will now be sold as a 12-week
smoking cessation treatment that includes a user's guide and
audio tape.
Nicorette gum, when used according to directions, delivers a
low level of nicotine that helps reduce craving and other
withdrawal symptoms.
Almost half of those who use Nicorette are able to stop
smoking for at least a few days, but many start smoking again.
Most smokers must try to quit several times before they
completely stop. The one-month quit rates among smokers who use
-more- Page 2, T96-10, Nicorette for OTC Marketing
Nicorette and who seek no additional treatment (i.e. via support
groups) is less than 10 percent. Approximately 45 to 50 million
U.S. adults are addicted to nicotine.
Persons with significant heart disease should speak with
their doctors before using Nicorette. And, as is the case with
any gum product, some people using Nicorette may experience
problems with their teeth or dental work.
SmithKline Beecham Consumer Healthcare of Pittsburgh markets
Nicorette gum.
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