Head-to-head Study Results Demonstrated No Significant Difference Between NicoDerm CQ and Chantix (Varenicline Tartrate) in Long Term Quit Rates

Therapeutic nicotine (TN) remains first-line treatment option

PITTSBURGH, July 28, 2008 /PRNewswire/ -- New data published today in the August issue of Thorax shows no significant differences in 6-month and 1-year quit rates between the NicoDerm(R) CQ(R) Clear Patch and Chantix (varenicline tartrate) despite statistically higher quit rates for Chantix (varenicline tartrate) at 12 weeks. According to the official 2008 U.S. Public Health Service Guideline, longer-term quit rates at the 6-month milestone are the most predictive of long-term success.

The Thorax paper, entitled, "Varenicline versus transdermal nicotine patch for smoking cessation: results from a randomised open-label trial", reports on a 52-week study that is the first-ever direct comparison of the NicoDerm CQ Clear Patch to Chantix (varenicline tartrate). The study was conducted using an "open-label" design, meaning that subjects knew what medication they were taking. Though this design may have favored the new pill, Chantix (varenicline tartrate) did not demonstrate long-term superiority to NicoDerm CQ.

"This study confirms that there is no magic bullet when it comes to smoking cessation and that both therapeutic nicotine and Chantix (varenicline tartrate) demonstrate long-term effectiveness," stated Dr. Howard Marsh, vice president of Worldwide Medical Affairs for GlaxoSmithKline Consumer Healthcare. "There is also no single approach that will work for everyone. For example, a substantial proportion of quit attempts are made spontaneously, without much planning. Therapeutic nicotine is widely available without the need for a prescription or a visit to a doctor's office."

Each smoking cessation medicine has been proven effective. In separate double blind placebo-controlled studies for NicoDerm CQ and Chantix (varenicline tartrate), NicoDerm CQ patch had a 45 percent success rate (vs. 18 percent for placebo) at the end of 10-week treatment and Chantix (varenicline tartrate) had a success rate of 44 percent (vs. 18 percent for placebo) at the end of 12-week treatment.

In fact, the recently updated 2008 U.S. Public Health Service Guideline recommends these products as well as Commit(R) lozenge and Nicorette(R) gum as first-line therapy for quitting, as they significantly increase rates of long-term smoking abstinence.

Dr. Howard Marsh continued, "The aim of all quitters is to quit for good, so although short-term quit rates are useful indicators of efficacy, long-term abstinence will prolong improved health. These results confirm that NicoDerm CQ patch enables a significant proportion of patients to quit for a year."

Over-the-counter therapeutic nicotine products like NicoDerm CQ patch, Nicorette gum and Commit lozenge are first-line treatments for smoking cessation and are thoroughly researched, well-understood and highly accessible stop smoking therapies. Unfortunately, the majority of smokers try to quit with no assistance at all and only 3-5 percent of smokers who quit "cold turkey" are successful long-term.

GlaxoSmithKline Consumer Healthcare's family of over-the-counter therapeutic nicotine products, NicoDerm CQ patch, Nicorette gum and Commit lozenge have helped more than six million smokers around the world quit successfully. Of these smokers, over three million have successfully quit smoking specifically with the help of the NicoDerm CQ patch.

Consistent with their FDA-approved labeling, the GlaxoSmithKline Consumer Healthcare's therapeutic nicotine products help reduce nicotine withdrawal symptoms, including nicotine craving, associated with quitting smoking. Therapeutic nicotine products are designed to allow smokers to wean off nicotine gradually and safely. GlaxoSmithKline Consumer Healthcare's therapeutic nicotine products are available without a doctor's prescription, in flexible dosing options at over 35,000 retail outlets across the country. So a smoker who wants to quit doesn't have to wait to see a doctor to get help.

With more than 10 years of experience in smoking cessation therapy, GlaxoSmithKline Consumer Healthcare understands successful quitting requires breaking the dependence on tobacco and changing behaviors associated with smoking. GlaxoSmithKline Consumer Healthcare recommends that quitters wanting to improve their chances of success use our individually-tailored Committed Quitters(R) program or other behavioral support programs in combination with our therapeutic nicotine products. Our tailored Committed Quitters program is available to anyone, and further increases a smoker's chances of quitting.

For more information on the Committed Quitters program and managing both the physical and psychological aspects of smoking dependence, visit http://www.Way2Quit.com, a comprehensive smoking cessation resource offered by GlaxoSmithKline Consumer Healthcare.

Notes to editors:

"Varenicline versus transdermal nicotine patch for smoking cessation: results from a randomised open-label trial". The head to head study was a 52 week, open-label, randomised, multicenter trial conducted in Belgium, France, the Netherlands, UK and U.S.A. Seven hundred and forty-six participants were eligible for primary analysis. Participants were randomly assigned to receive Chantix (varenicline tartrate) for 12 weeks or transdermal therapeutic nicotine for 10 weeks. The primary endpoint was confirmed abstinence for the last four weeks of treatment and secondary endpoints were 24 and 52 week confirmed abstinence, and effect on craving and withdrawal symptoms.

About GlaxoSmithKline Consumer Healthcare

GlaxoSmithKline Consumer Healthcare is one of the world's largest over-the-counter consumer healthcare products companies. Its more than 30 well-known brands include the leading smoking cessation products, Nicorette(R) and NicoDerm(R)CQ(R), and Commit(R), as well as many medicine cabinet staples -- alli(R), Aquafresh(R), Sensodyne(R), and TUMS(R) -- 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.

CONTACT: Mark Polisky, of GolinHarris, +1-312-729-4417,, for GlaxoSmithKline; or Jennifer May ofGlaxoSmithKline Consumer Healthcare, +1-412-200-3729, mpolisky@golinharris.com jennifer.l.may@gsk.com

Web site: http://www.gsk.com//

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Posted: July 2008

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