A Statement from GlaxoSmithKline Consumer Healthcare on FDA Workshop to Explore Extended Use of Nicotine Replacement Therapy

Oct 28, 2010, 08:00 ET from GlaxoSmithKline Consumer Healthcare

PARSIPPANY, N.J., Oct. 28 /PRNewswire/ -- GlaxoSmithKline Consumer Healthcare strongly supports the Food and Drug Administration for holding a scientific workshop this week that focused on the risks and benefits associated with the long-term use of nicotine replacement therapy (NRT) products.  GSK views this workshop as a first step in supporting language in the 2009 Family Smoking Prevention and Tobacco Control Act which called upon FDA to "consider approving the extended use of nicotine replacement products (such as nicotine patches, nicotine gum and nicotine lozenge) for the treatment of tobacco dependence."(1)

Smoking is the number one preventable cause of disease and death in the United States.  More than 46 million Americans smoke.(2)  Research indicates about 70 percent of them want to quit at any given time, but the success rates remain sub-optimal.(2)  Tobacco use causes over 400,000 deaths in the United States each year, and approximately 8.6 million Americans have chronic illnesses related to smoking.(2)

As a result of the FDA's review of long-term use, GSK has submitted a statement into the FDA public docket on its position regarding the long-term use of NRT.  GSK believes that using NRT products to quit smoking is far safer than continuing to smoke.(3)  In fact, there is overwhelming evidence that NRT products such as NicoDerm® CQ® patch and Nicorette® gum and lozenge*, have safely and effectively helped millions of people around the world quit smoking over the past 20 years, and, as a result, have significantly reduced their exposure to the risks of cancer and other smoking-related diseases.(4)  NRT products offer a step-down therapy that doubles a smoker's chances of quitting versus cold turkey.(5)  Additionally, several other countries already encourage the use of NRT products for longer durations to keep people tobacco-free.

Leading experts in the field of smoking control, non-governmental bodies such as the World Health organization (WHO) and many governments around the world agree that NRT products have a crucial role to play in helping to reduce the devastating toll of disease caused by tobacco dependence.(6)  Additionally, the 2008 U.S. Public Health Service Guideline, "Treating Tobacco Use and Dependence," recommends NRT products as a first-line therapy for quitting, as they "increase significantly rates of long-term smoking abstinence."(7)   In fact, these guidelines along with several studies support the use of NRT products longer than directed for a subset of smokers for whom longer-term use of NRT products is needed to keep them tobacco-free.(7,8,9)  

If the overriding goal is to help smokers escape their tobacco dependence and the consequences associated with smoking, then GSK urges the FDA to consider permitting longer-term use of NRT products when necessary.  GSK is committed to continuing to work with medical and clinical experts, and the FDA, to ensure that consumers have the best possible chance to quit smoking.

*brand name is NiQuitin in the U.K. and Nicabate in Australia

1. Family Smoking Prevention and Tobacco Control Act, U.S. Government, 2009.

2. American Cancer Society "Guide to Quitting Smoking" Available at http://www.cancer.org/docroot/PED/content/PED_10_13X_Guide_for_Quitting_Smoking.asp

3. Benowitz NL. Summary: risks and benefits of nicotine. Nicotine Safety and Toxicity. Oxford University Press, New York, 1998:185-194.

4. GSK Data on file.

5. Stead LF, Perera R, Bullen C, Mant D, Lancaster T. Nicotine replacement therapy for smoking cessation. Cochrane Database of Systematic Reviews 2008, Issue 1. Art. No.: CD000146. DOI: 10.1002/14651858.CD000146.pub3.  Available at: http://www.cochrane.org/reviews/en/ab000146.html .

6. World Bank.  Curbing the epidemic: governments and the economics of tobacco control, 1999; www.worldbank.org/tobacco/reports.htm.

7. Fiore MC, Jaen CR, Baker TB, et al. Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Services. Public Health Service. May 2008.

8. Hajek P; McRobbie H; Gillison F. Dependence potential of nicotine replacement treatment: Effects of product type, patient characteristics, and cost to user. Preventive Medicine 2007 March:44(3):230-234.

9. Schnoll, R, et. al. Effectiveness of Extended-Duration Transdermal Nicotine Therapy. Annals of Internal Medicine 2010 February: Volume 152, Number 3.


Deborah Bolding

Teresa Murtaugh

GlaxoSmithKline Consumer Healthcare






SOURCE GlaxoSmithKline Consumer Healthcare