Pfizer Inc announced today
that CHANTIX(TM) (varenicline) is now available in U.S. pharmacies.
CHANTIX,
the first new prescription aid to smoking cessation treatment
approved by the U.S. Food and Drug Administration in nearly a decade,
was
approved in May 2006. Those who are prescribed CHANTIX will be offered
the opportunity to enroll in a behavioral modification program called
GETQUIT(TM) Support Plan at no additional cost. The plan was developed
by Pfizer with input from smoking cessation experts.
"By developing CHANTIX to help people quit smoking, we hope to take a positive step toward improving the health of smokers, their families and friends, and society in general," said Karen Katen, Pfizer vice chairman and president of Pfizer Human Health. "Quitting smoking is challenging physiologically and psychologically. Oftentimes, smokers are very much on their own during the difficult quitting process. To help people break free from the powerful grip of smoking, we are offering CHANTIX with a personalized behavior modification program called GETQUIT Support Plan. It is our hope that this will help smokers achieve their goal of living smoke-free."
There are 45 million adult smokers in the U.S., but approximately 70 percent say they want to quit. CHANTIX offers an important advance in smoking cessation. When a smoker takes CHANTIX as part of their efforts to quit, it is believed that the medication binds to the same receptors to which nicotine would bind, but CHANTIX appears to activate the receptors to a much lesser extent. Also, if a person does smoke while taking CHANTIX, CHANTIX may block the nicotine from binding and lessen nicotine's effects.
Behavioral Support Available to Patients Prescribed CHANTIX
Nicotine addiction is a chronic medical condition that is difficult to overcome. According to a research report on nicotine addiction from The National Institute on Drug Abuse, less than 7 percent of smokers who try to quit achieve at least one year of abstinence. That same report says that most smokers relapse within a few days of attempting to quit. However, for individuals who are motivated to quit smoking, literature has shown that a combination of medication and behavior modification can increase successful quit rates.
The GETQUIT(TM) Support Plan was developed using principles of cognitive therapy with input from smoking cessation experts to help educate patients about managing cravings and behavioral triggers. It will be available at no additional cost to CHANTIX patients. The plan will feature extensive behavior modification support that patients can customize to their individual needs, including a "Habit Changer" to identify and address their personal triggers to smoke, and daily communications that help them track their progress. "The U.S. Public Health Service Clinical Practice Guidelines say that increased behavioral support is associated with significantly better chances of quitting. At this time, there are many initiatives being passed in various states, including clean air laws, as well as the adoption of smoke-free workplaces that are designed to discourage smoking and drive people to consider a quit attempt," said Dr. Scott Leischow, a behavioral specialist and professor in the Department of Family and Community Medicine at the University of Arizona. "It is critically important that, when smokers want to try to quit, they have access to behavioral support programs and treatment modalities to help them in their quit attempts."
Smoking Cessation Benefits and CHANTIX Coverage
Smoking is the leading preventable cause of disease and premature death in the U.S. Smoking is also financially costly. Smokers spend an average of $700 per year on cigarettes and according to the American Lung Association, the economic cost of smoking on an annual basis is approximately $167 billion in the U.S.
Currently, however, many smokers do not have access to smoking cessation benefits. According to the Centers for Disease Control (CDC), although 66 percent of Americans under the age of 65 are insured through an employer, only 24 percent of employers offer coverage for treatment of tobacco use. Last month, the CDC released a new guide, Save Lives, Save Money: Make Your Business Smoke-Free, which recommends that employers, among other actions, check with their HMOs to see if their policies cover smoking cessation services. If they do not, the CDC recommends that they consider the addition of coverage for cessation services.
Patients who have insurance programs that cover the cost of prescription medicine should check with their insurance carrier and employer to see if they cover CHANTIX. Pfizer is working with third party payers to facilitate reimbursement of CHANTIX. The price of CHANTIX will vary depending on what a retail pharmacy charges for the product.
For those without insurance for prescription medicines, CHANTIX may be available through Pfizer Helpful Answers -- a family of programs that helps people without prescription coverage save on many Pfizer medicines, no matter their age or income. People with limited incomes may even qualify to get their Pfizer medicines for free. For more information call toll free 1-866-706-2400 or visit http://www.PfizerHelpfulAnswers.com.
CHANTIX Shown Effective in Clinical Trials
In two identically designed clinical trials, approximately 44 percent of patients who took CHANTIX (1 mg twice a day) quit smoking by the end of the 12-week treatment period versus approximately 30 percent who used buproprion SR (150 mg twice a day) and approximately 18 percent who used placebo. In a separate study, patients who quit with 12 weeks of treatment with CHANTIX were randomized to receive an additional 12 weeks of treatment with CHANTIX or placebo. At the end of a total of 24 weeks of therapy, 70.5 percent of patients who continued on CHANTIX remained smoke-free compared to 50 percent who switched to placebo.
CHANTIX Dosing Information
After a one week titration, the recommended dosing of CHANTIX is 1 mg twice a day. CHANTIX comes in user-friendly packaging. Each monthly package contains four weekly dosing packs.
Safety Information
CHANTIX is indicated as an aid to smoking cessation treatment in adults. The most frequently reported adverse events (>10 percent) with CHANTIX were nausea, headache, insomnia, and abnormal dreams.
Nausea was reported by approximately 30 percent of patients treated with CHANTIX (1 mg twice a day), with approximately a 3 percent discontinuation rate during 12 weeks of treatment. Nausea was generally described as mild or moderate and often transient. For some subjects, it was persistent over the course of treatment. Dose adjustment with CHANTIX is recommended in subjects with severe renal impairment. Patients who cannot tolerate adverse effects of CHANTIX may have the dose lowered temporarily or permanently.
In November 2005, Pfizer submitted a European marketing authorization application for varenicline for smoking cessation.
Patients and health care providers can visit http://www.chantix.com or call 1-877-CHANTIX to receive more information about CHANTIX.
To preview and request free broadcast-standard video about this announcement digitally or by tape please log onto http://www.thenewsmarket.com/pfizer.
Pfizer Inc
http://www.pfizer.com
"By developing CHANTIX to help people quit smoking, we hope to take a positive step toward improving the health of smokers, their families and friends, and society in general," said Karen Katen, Pfizer vice chairman and president of Pfizer Human Health. "Quitting smoking is challenging physiologically and psychologically. Oftentimes, smokers are very much on their own during the difficult quitting process. To help people break free from the powerful grip of smoking, we are offering CHANTIX with a personalized behavior modification program called GETQUIT Support Plan. It is our hope that this will help smokers achieve their goal of living smoke-free."
There are 45 million adult smokers in the U.S., but approximately 70 percent say they want to quit. CHANTIX offers an important advance in smoking cessation. When a smoker takes CHANTIX as part of their efforts to quit, it is believed that the medication binds to the same receptors to which nicotine would bind, but CHANTIX appears to activate the receptors to a much lesser extent. Also, if a person does smoke while taking CHANTIX, CHANTIX may block the nicotine from binding and lessen nicotine's effects.
Behavioral Support Available to Patients Prescribed CHANTIX
Nicotine addiction is a chronic medical condition that is difficult to overcome. According to a research report on nicotine addiction from The National Institute on Drug Abuse, less than 7 percent of smokers who try to quit achieve at least one year of abstinence. That same report says that most smokers relapse within a few days of attempting to quit. However, for individuals who are motivated to quit smoking, literature has shown that a combination of medication and behavior modification can increase successful quit rates.
The GETQUIT(TM) Support Plan was developed using principles of cognitive therapy with input from smoking cessation experts to help educate patients about managing cravings and behavioral triggers. It will be available at no additional cost to CHANTIX patients. The plan will feature extensive behavior modification support that patients can customize to their individual needs, including a "Habit Changer" to identify and address their personal triggers to smoke, and daily communications that help them track their progress. "The U.S. Public Health Service Clinical Practice Guidelines say that increased behavioral support is associated with significantly better chances of quitting. At this time, there are many initiatives being passed in various states, including clean air laws, as well as the adoption of smoke-free workplaces that are designed to discourage smoking and drive people to consider a quit attempt," said Dr. Scott Leischow, a behavioral specialist and professor in the Department of Family and Community Medicine at the University of Arizona. "It is critically important that, when smokers want to try to quit, they have access to behavioral support programs and treatment modalities to help them in their quit attempts."
Smoking Cessation Benefits and CHANTIX Coverage
Smoking is the leading preventable cause of disease and premature death in the U.S. Smoking is also financially costly. Smokers spend an average of $700 per year on cigarettes and according to the American Lung Association, the economic cost of smoking on an annual basis is approximately $167 billion in the U.S.
Currently, however, many smokers do not have access to smoking cessation benefits. According to the Centers for Disease Control (CDC), although 66 percent of Americans under the age of 65 are insured through an employer, only 24 percent of employers offer coverage for treatment of tobacco use. Last month, the CDC released a new guide, Save Lives, Save Money: Make Your Business Smoke-Free, which recommends that employers, among other actions, check with their HMOs to see if their policies cover smoking cessation services. If they do not, the CDC recommends that they consider the addition of coverage for cessation services.
Patients who have insurance programs that cover the cost of prescription medicine should check with their insurance carrier and employer to see if they cover CHANTIX. Pfizer is working with third party payers to facilitate reimbursement of CHANTIX. The price of CHANTIX will vary depending on what a retail pharmacy charges for the product.
For those without insurance for prescription medicines, CHANTIX may be available through Pfizer Helpful Answers -- a family of programs that helps people without prescription coverage save on many Pfizer medicines, no matter their age or income. People with limited incomes may even qualify to get their Pfizer medicines for free. For more information call toll free 1-866-706-2400 or visit http://www.PfizerHelpfulAnswers.com.
CHANTIX Shown Effective in Clinical Trials
In two identically designed clinical trials, approximately 44 percent of patients who took CHANTIX (1 mg twice a day) quit smoking by the end of the 12-week treatment period versus approximately 30 percent who used buproprion SR (150 mg twice a day) and approximately 18 percent who used placebo. In a separate study, patients who quit with 12 weeks of treatment with CHANTIX were randomized to receive an additional 12 weeks of treatment with CHANTIX or placebo. At the end of a total of 24 weeks of therapy, 70.5 percent of patients who continued on CHANTIX remained smoke-free compared to 50 percent who switched to placebo.
CHANTIX Dosing Information
After a one week titration, the recommended dosing of CHANTIX is 1 mg twice a day. CHANTIX comes in user-friendly packaging. Each monthly package contains four weekly dosing packs.
Safety Information
CHANTIX is indicated as an aid to smoking cessation treatment in adults. The most frequently reported adverse events (>10 percent) with CHANTIX were nausea, headache, insomnia, and abnormal dreams.
Nausea was reported by approximately 30 percent of patients treated with CHANTIX (1 mg twice a day), with approximately a 3 percent discontinuation rate during 12 weeks of treatment. Nausea was generally described as mild or moderate and often transient. For some subjects, it was persistent over the course of treatment. Dose adjustment with CHANTIX is recommended in subjects with severe renal impairment. Patients who cannot tolerate adverse effects of CHANTIX may have the dose lowered temporarily or permanently.
In November 2005, Pfizer submitted a European marketing authorization application for varenicline for smoking cessation.
Patients and health care providers can visit http://www.chantix.com or call 1-877-CHANTIX to receive more information about CHANTIX.
To preview and request free broadcast-standard video about this announcement digitally or by tape please log onto http://www.thenewsmarket.com/pfizer.
Pfizer Inc
http://www.pfizer.com
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Advanced Male Medical Center
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