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A Statement From GlaxoSmithKline Consumer Healthcare on the Petition to FDA to Help People Quit Smoking

Thursday, February 18, 2010 General News J E 4
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PITTSBURGH, Feb. 17 GlaxoSmithKline (GSK) Consumer Healthcare, marketer of nicotine replacement therapy (NRT) products, including Nicorette®, NicoDerm® CQ® and Commit®, applauds two leading smoking cessation organizations for their efforts to improve the regulation of smoking cessation aids designed to help people quit smoking.

A citizen petition, filed jointly by the Association for the Treatment of Tobacco Use and Dependence (ATTUD) and the Society for Research on Nicotine and Tobacco (SRNT), urged the FDA to adopt a more flexible regulatory approach to expand access to and use of NRT products. These smoking cessation products have helped millions of people around the world quit smoking and, as a result, have significantly reduced their exposure to the risks of cancer and other smoking-related diseases.(1)

GSK Consumer Healthcare agrees that the packaging and labeling of these products should reflect the best available science to reduce barriers for smokers to access life-saving treatments. While the FDA is the final authority on the labeling of GSK's NRT products sold in the U.S., GSK is committed to continuing to work with medical and clinical experts, and the FDA, to assure that consumers have the best possible chance to quit smoking, and stands ready to assist in the effort.

Quitting smoking is the single most important step smokers can take to improve their health - and it's also one of the most difficult. NRT products can help smokers break their dependence on tobacco and safely wean off nicotine.(2) Clinical trials have demonstrated that these products can double a smoker's chances of quitting versus placebo.(3) They are extensively proven to significantly reduce cravings and other withdrawal symptoms during quitting, allowing smokers to focus on behavior change.(2)

By developing innovative new products and support systems to improve the quit experience, and helping to make the products as accessible as possible, GSK Consumer Healthcare is working to inspire and enable every smoker to quit.

(1) GSK data on file.

(2) Shiffman S, Di Marino ME, Pillitteri JL. The effectiveness of nicotine patch and nicotine lozenge in very heavy smokers. J Subst Abuse Treat. 2005 Jan;28(1):49-55.

(3) Silagy et al. Nicotine replacement therapy for smoking cessation (Cochrane Review). In: The Cochrane Library, Issue 1, 2004. Chichester, UK: John Wiley & Sons, LTD.

SOURCE GlaxoSmithKline Consumer Healthcare
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