News Release

New brain imaging shows effects of withdrawal on smokers

Peer-Reviewed Publication

GolinHarris International

New Brain Imaging Shows The Effects of Withdrawal on Smokers Trying to Quit and How Therapeutic Nicotine Helps

Former US Surgeon General C. Everett Koop and panel of experts discuss new implications for physicians who treat smokers

San Diego, CA – Sept. 18, 2008 – New research highlighted at a symposium during an annual meeting for family physicians shows how nicotine withdrawal creates functional changes in the brains of smokers trying to quit causing cognitive performance deficits (such as ability to concentrate) that may make it more difficult to quit, and could be a driver of smoking relapse.1 Further, brain imaging technology shows that when treatment with the Commit® 4 mg nicotine lozenge is introduced, these symptoms of nicotine withdrawal can be reversed.2 This information is helping physicians better understand addiction and how treatment can help.

"The new research provides powerful new evidence as to why physicians need to intervene and help their patients understand and manage symptoms to help them quit successfully," said Dr. C. Everett Koop, former U.S. Surgeon General and driving force behind the 1988 Surgeon General's report entitled: The Health Consequences of Smoking: Nicotine Addiction. "Physicians should use these new data as reasons to speak with their patients to help them better understand their addiction, including the serious impact of withdrawal and how proven treatments can help reverse nicotine withdrawal symptoms that impact the brain."

Data from two similar studies were highlighted at the symposium. The studies reviewed the impact of nicotine withdrawal on the brain and demonstrated that the Commit 4 mg nicotine lozenge can significantly help reverse nicotine withdrawal symptoms associated with quitting smoking.3

Specific areas in the brain, particularly those associated with executive functioning, are impacted during nicotine withdrawal. The Commit 4 mg nicotine lozenge significantly improved cognitive performance compared to placebo and lessened symptoms of withdrawal including craving, difficulty concentrating, irritability and restlessness.3 Other nicotine withdrawal symptoms including short-term memory deficit, and selective and divided attention deficits were also significantly reduced.3

"In withdrawal, a smoker's brain is literally in dysfunction and this can impair the quitter's ability to think and act," said Dr. Jack Henningfield, Professor in the Department of Psychiatry and Behavioral Sciences at Johns Hopkins University School of Medicine and Vice President of Research and Health Policy at Pinney Associates and consultant to GlaxoSmithKline (GSK) Consumer Healthcare. "Research on the brain in withdrawal is important as it helps physicians and smokers trying to quit recognize and manage the symptoms. For smokers who experience withdrawal and can't afford lapse in concentration or judgement, FDA-approved medicines for smoking cessation such as the Commit 4 mg nicotine lozenge may make the difference between success and failure in their smoking cessation efforts."

Consistent with their FDA-approved labelling, therapeutic nicotine products are specifically designed to curb withdrawal symptoms by safely and gradually weaning a smoker off nicotine. The Commit 4 mg nicotine lozenge has shown in this research that it specifically improves symptoms of withdrawal including craving, difficulty concentrating, irritability and restlessness.3

Therapeutic nicotine products, including the Commit 4 mg nicotine lozenge, can double a smoker's chances of quitting versus placebo and remaining smoke-free long-term (6 months and longer.)4 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.5 Research from more than 110 clinical trials involving over 40,000 participants have established the safety and efficacy profile of therapeutic nicotine products when used as directed.4 Therapeutic nicotine products are readily available at over 35,000 retail outlets around the country and are available in flexible dosing options-so a smoker who wants to quit doesn't have to wait to see a doctor to get help.6

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About the Commit Lozenge

Commit is approved by the FDA to help control cravings associated with quitting smoking. Commit has a unique dosage selector based on how soon a smoker smokes his first cigarette in the morning, so he can choose the strength that's right for him. The Commit lozenge helps people stop smoking by providing low, safe doses of therapeutic nicotine to ease withdrawal from cigarettes. Commit comes in different strengths—2 mg or 4 mg—to be used depending on how soon a smoker has his first cigarette in the morning. The 2 mg dosage is for smokers who usually have their first cigarette more than thirty minutes after waking up. The 4 mg dosage is for smokers who usually have their first cigarette within thirty minutes of waking up. For more information visit www.commitlozenge.com.

About GlaxoSmithKline Consumer Healthcare

GSK Consumer Healthcare is one of the world's largest over-the-counter consumer healthcare products companies. More than 30 well-known brands including the leading smoking cessation products, Nicorette®, NicoDerm®CQ®, and Commit®, as well as many medicine cabinet staples-- alli®, Aquafresh®, Sensodyne®, and TUMS® -- are trademarks owned by and/or licensed to GlaxoSmithKline Group of Companies.

About the Research

The first study entitled, "Efficacy of a Nicotine Lozenge on Nicotine Withdrawal Induced Cognitive Impairment," conducted by GSK Consumer Healthcare, was a single-center, evaluator and subject blind, randomised, placebo-controlled, two-period crossover study in male and female adult smokers between the ages of 21 to 55 years old. The second study entitled, "Imaging Brain Cognitive Effects of Nicotine Withdrawal and the Impact of Treatment," conducted by the University of Surrey, Guildford and funded by GSK, was a single-blind, placebo-controlled, crossover study in male and female adult smokers. The study used functional magnetic resonance imaging (fMRI) which provides a measure of information processing in the brain by measuring blood oxygen levels to show how the brain works. The test shows how treatment affects certain areas of the brain.

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.

1 Henningfield, J. The brain in withdrawal; neuroscience of treatment. AAFP presentation. September 2008.

2 Boyle, J, Durcan MJ, et al. Efficacy of a nicotine (4mg) containing lozenge on the cognitive impairment of nicotine withdrawal. Poster presented at the annual European meeting of the Society for Research on Nicotine and Tobacco, Padua, Italy.

3 Matthews, P. Imaging brain cognitive effects of nicotine withdrawal and the impact of treatment. AAFP presentation. September 2008.

4 Silagy C, Stead LF, et. al. Nicotine replacement therapy for smoking cessation. Cochrane Database of Systematic Reviews 1996, Issue 3. Art. No.: CD000146. DOI: 10.1002/14651858.CD000146.pub3. Available at: http://www.cochrane.org/reviews/en/ab000146.html

5 Fiore MC, Jaén 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.

6 GSK Data on file.


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