A Statement From GlaxoSmithKline Consumer Healthcare on FDA Public Hearing Regarding Expanded Use of Smoking Cessation Products

PARSIPPANY, N.J., Dec. 17, 2012 /PRNewswire/ -- GlaxoSmithKline (GSK) Consumer Healthcare looks to the U.S. Food and Drug Administration (FDA) to advance the discussion of expanded uses of smoking cessation medicines, including nicotine replacement therapy (NRT), by holding a hearing related to Sec. 918 of the 2009 Family Smoking Prevention and Tobacco Control Act.

GSK endorses FDA's actions and any action designed to help more smokers stop their dependence on tobacco, and strongly recommends the FDA adopt a comprehensive regulatory policy that allows smokers options of flexible and novel approaches for quitting.

Currently, more than 45 million Americans continue to smoke, and research indicates approximately 70 percent of them want to quit. However, success rates remain sub-optimal. 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.

Opening the discussion around Sec. 918 represents a tremendous opportunity to maximize the public health impact and lead to an increased interest and ability to quit. Numerous clinical studies and the current U.S. Public Health Service (PHS) Guideline on Treating Tobacco Use and Dependence already support the use of extended indications for NRT. In fact, these guidelines support the use of NRT products longer than directed for a subset of smokers for whom flexible use of NRT products is needed to help them quit smoking.

There is an abundance of evidence that NRT products have safely and effectively 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. Several other countries already encourage the use of NRT products for longer durations and with more flexible indications.

Comments gathered at the FDA hearing will be compiled in a report to Congress recommending how to best regulate, promote and encourage innovative cessation treatments. GSK is committed to continuing to work with medical and clinical experts and the FDA to ensure smokers have the best possible chance to quit smoking. GSK will submit written comments into the FDA public docket on its position regarding Sec. 918 in Jan., 2013.

About GlaxoSmithKline Consumer Healthcare

GlaxoSmithKline Consumer Healthcare is one of the world's largest over-the-counter consumer healthcare products companies. Its well-known brands include Nicorette^® and NicoDerm^® CQ, the leading smoking cessation products; alli, the only FDA-OTC weight loss aid; as well as medicine cabinet staples, Aquafresh^®, Sensodyne^®, Tums^®, and Breathe Right^®, all of which are trademarks owned by and/or licensed to GlaxoSmithKline Group of Companies.

About GlaxoSmithKline

GlaxoSmithKline one of the world's leading research-based pharmaceutical and healthcare companies is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information visit: http://www.gsk.com.

SOURCE GlaxoSmithKline Consumer Healthcare