First New Prescription Smoking Cessation Treatment Approved In A DecadeFIRST NEW PRESCRIPTION SMOKING CESSATION TREATMENT APPROVED IN A DECADE
CHAMPIX™, the first in a new class of medications, provides superior efficacy in smoking cessation
| Kirkland, Quebec - February 01, 2007 |
Canadians now have a new option to help them quit smoking. Health Canada has approved CHAMPIX (varenicline tartrate) for smoking cessation treatment in adults in conjunction with smoking cessation counselling. In Canada, approximately 19 per cent of the population 15 years and older smoke1. Globally, it is estimated that as many as 80 per cent would like to quit, but only five per cent will succeed with no external assistance.2,3 In clinical trials, people receiving a 12-week course of CHAMPIX nearly quadrupled the likelihood of quitting smoking compared with those taking placebo, and had nearly twice the likelihood of quitting than those patients taking bupropion SR (Zyban*). "The Health Canada approval of CHAMPIX is good news for the almost five million Canadians who smoke," says Dr. Andrew Pipe, Medical Director of the University of Ottawa Heart Institute Prevention and Rehabilitation Centre, and Professor at the University of Ottawa. "Smoking is an addiction; not simply a habit. Nicotine dependency is a medical condition which makes quitting difficult. Smokers who are truly motivated to quit deserve support and the tools to be successful. CHAMPIX is a novel treatment with the potential to help many Canadians break the smoking cycle." CHAMPIX is unique because it is specifically designed to partially activate the nicotinic receptors in the brain and reduce a smoker's craving and withdrawal symptoms. Moreover, if a person smokes a cigarette while receiving treatment, CHAMPIX has the potential to diminish the sense of satisfaction associated with smoking.4 "I have smoked for over 50 years and I tried to quit once but just moved on to the pipe," said Marcel Lalonde, a former smoker. "Only when I realized that you need to combine medication with counselling was I able to quit smoking for good." Strong evidence suggests that smoking tobacco is related to more than two dozen diseases and conditions including cancer, cardiovascular diseases and respiratory diseases and symptoms.5 Health Canada has approved CHAMPIX according to their performance target date. CHAMPIX should be available in pharmacies in late April. Canadians interested in getting help to quit smoking, including learning more about CHAMPIX, should speak to their doctor. "This is an important milestone in the history of smoking cessation," said Dr. Bernard Prigent, Vice-President, Medical Affairs, Pfizer Canada. "Pfizer is committed to a wide range of therapeutic areas including cardiovascular disease and oncology. CHAMPIX is an innovative medical advancement and provides superior efficacy in smoking cessation." About Smoking
Nicotine addiction is a chronic medical condition6 that makes quitting smoking difficult. When inhaled, smoke from a cigarette reaches the brain within seconds and binds to nicotinic receptors, which activates the reward pathway and stimulates the pleasure centre in the brain. Over time, the body builds a tolerance to nicotine, which allows smokers to increase the amount of nicotine smoked without showing any immediate side effects.7 In Canada, smoking is responsible for 45,000 deaths annually, which is more than the total number of deaths from AIDS, car accidents, suicide, murder, fires and accidental poisonings combined.8 According to Health Canada, close to half of smokers will die from smoking before they turn 70 years old, after years of suffering reduced quality of life.9 Smoking is the single most important preventable cause of lung cancer, contributing to 85 per cent of all new cases in Canada.5 As well, smoking increases a person's risk of developing heart disease and stroke by contributing to a build-up of plaque in arteries, increased risk of blood clots, reduced oxygen in the blood, and increased blood pressure.10 About CHAMPIX
CHAMPIX, the first in a new class of prescription medications, is approved for smoking cessation treatment in adults in conjunction with smoking cessation counselling. CHAMPIX is specifically designed for smoking cessation. Unlike some other products, it is not a nicotine replacement therapy and therefore does not deliver any nicotine into the body. It works by specifically targeting nicotinic receptors in the brain to reduce craving, and no other treatment works this way. CHAMPIX's approval was based on a comprehensive clinical trial program including four pivotal trials involving almost 4,000 cigarette smokers. Participants, on average, had smoked about 21 cigarettes per day for an average of approximately 25 years. In two identically designed studies, participants receiving a 12-week course of CHAMPIX therapy (1 mg twice daily) nearly quadrupled the likelihood of quitting than those taking placebo and had nearly twice the likelihood of quitting than those patients taking bupropion SR (150 mg twice daily). Enrolled patients were provided with education materials. Patients were followed for an additional 40 weeks without treatment. After one year, approximately one-in-five patients who received the 12-week course of CHAMPIX remained smoke-free. In another study, a second course of CHAMPIX treatment in patients who quit at the end of the first course showed a greater likelihood of long-term success in quitting smoking. In clinical trials CHAMPIX was found to be safe and well tolerated. The most commonly observed adverse events associated with CHAMPIX(>5% and twice the rate seen in placebo-treated patients) were nausea, abnormal dreams, constipation, flatulence, and vomiting. CHAMPIX has been approved in the United States (under brand name CHANTIX) and the European Union. About Pfizer Canada
Pfizer Canada Inc. is the Canadian operation of Pfizer Inc, the world's leading pharmaceutical company. Pfizer discovers, develops, manufactures and markets leading prescription medicines for humans and animals. Pfizer Canada employs more than 1,800 people across the country. Canadian headquarters of Pfizer Global Pharmaceuticals Group is in Kirkland, Quebec. For more information, visit www.pfizer.ca. - 30 - CHAMPIX™ (varenicline) is a registered trademark of Pfizer Canada.
*Zyban (bupropion SR) is a registered trademark of Glaxo Group Limited. A selection of photographs is available at a secure ftp site. For access information, please contact one of the people below. B-roll coordinates: Live Satellite Coordinates: | DATE OF FEED: | January 25, 2007 | | TIME OF FEED: | 1:00 pm ET - 1:30 PM | | CO-ORDINATES: | Anik F2, C Band Analog, Transponder 3B
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Search by story ID # 07NAT1 or by headline | Physicians are available for interview in Halifax, Montreal, Ottawa, Toronto, Calgary and Vancouver. References: 1Health Canada. Canadian Tobacco Use Monitoring Survey (CTUMS) 2005. July 10, 2006. Available at: http://www.hc-sc.gc.ca/hl-vs/tobac-tabac/research-recherche/stat/ctums-esutc/2005/index_e.html. Accessed January 15, 2007.
2Nicotine use disorder. In: Diagnostic and statistical manual of mental disorders: DSM-IV-TR. 4th ed., text revision. Washington, D.C.: American Psychiatric Association; 2000. p.264-5.
3Health Canada. Nicotine Replacement Therapies - NRT. May 31, 1999. Available at: http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/1999/1999_78bk2_e.html. Accessed: January 15, 2007.
4Gonzales D, Rennard SI, Nides M, Oncken C, Azoulay S, Billing CB, Watsky EJ, Gong J, Williams KE, Reeves KR, "Varenicline, an 4 2 Nicotinic Acetylcholine Receptor Partial Agonist, vs Sustained-Release Bupropion and Placebo for Smoking Cessation." JAMA. 2006; 296: 47-55.
5Smoking and Your Body. Health Canada. http://www.hc-sc.gc.ca/hl-vs/tobac-tabac/body-corps/index_e.html. Accessed on December 20, 2006.
6National Institute on Drug Abuse (1998). NIDA Notes: Fact about nicotine and tobacco products, Volume 13, Number 3 (July 1998). http://www.drugabuse.gov. Accessed on September 2005.
7Tobacco. Smoking and Your Body. Addiction. Health Canada. http://www.hc-sc.gc.ca/hl-vs/tobac-tabac/body-corps/nicotine/addiction-dependance/index_e.html Accessed on December 19, 2006.
7Facts About Smoking: The Truth About Smoking. The Lung Association. http://www.lung.ca/protect-protegez/tabacco-tabagisme/facts/index_e.php#truth. Accessed on December 19, 2006.
9Overview of Health Risks of Smoking. Health Canada. http://www.hc-sc.gc.ca/hl-vs/tobac-tabac/res/news-nouvelles/fs-if/risks-risques_e.html. Accessed on December 20, 2006.
10Smoking, Heart Disease and Stroke. Heart and Stroke Foundation of Canada. http://ww2.heartandstroke.ca/Page.asp?PageID=1975&ArticleID=5214&Src=heart&From=SubCategory. Accessed December 13, 2006. For more information please contact:
1-866-9Pfizer (1-866-973-4937)
These press releases were issued in Canada and are intended as reference information for Canadians. The information contained in each press release was accurate at the time of issuance, and Pfizer Canada assumes no responsibility for updating the information to reflect subsequent developments. |
