The nearly 50 million smokers now have an effective new treatment to help them quit. The U.S. Food and Drug Administration (FDA) today approved the Commit(tm) Lozenge -- the first and only nicotine lozenge -- for over-the-counter (OTC) sale. The Commit Lozenge, from the marketers of Nicorette, helps control cravings by delivering craving-fighting medicine fast. Additionally, its groundbreaking new dosage-selection tool, "Time to First Cigarette" (TTFC), enables smokers to get the right strength of nicotine based on how quickly they need to smoke after waking.
The Commit Lozenge has been shown to be effective in helping people quit, including smokers who have tried quitting before. The benefits of the Commit Lozenge were even greater when quitters used the minimum recommended number of lozenges per day in the early part of their quit attempts (i.e., nine lozenges per day for the first six weeks of therapy).
"As the marketers of Nicorette nicotine gum and NicoDerm CQ nicotine patch, we have provided increased access to safe and effective tools that have helped millions of smokers quit successfully," said Steve Burton, vice president of Smoking Control, Strategic Development and Switch at GlaxoSmithKline Consumer Healthcare. "We understand, however, that when trying to quit, smokers have different needs. Our newest option, the Commit Lozenge, provides smokers with a new treatment option to help them manage their quit attempts while also offering a unique dosage-selection tool to ensure that they are receiving the right amount of medicine."
The Commit Lozenge Features Unique Dosage Selection Tool: "Time to First Cigarette"
The Commit Lozenge uses a unique method for smokers to determine their degree of physical dependence on nicotine. This groundbreaking new indicator is called Time To First Cigarette (TTFC) and is available only with the Commit Lozenge. With TTFC, those who smoke their first cigarette within 30 minutes of waking are directed to use the 4mg strength of the Commit Lozenge, whereas those who smoke their first cigarette after 30 minutes of waking are directed to use the 2mg strength. Leading experts regard TTFC as one of the best indicators of dependence because all smokers wake up in a state of nicotine deprivation, and the drive to quickly self-administer is a strong indicator of nicotine dependence. Using TTFC means that smokers get the most appropriate strength for their needs, which can help improve their chances of quitting.
"Currently, smokers who use nicotine replacement therapy are instructed to self-select the appropriate strength based on the number of cigarettes they smoke per day. This marker of nicotine dependence may not be suitable for everyone, especially as smoking restrictions force smokers to smoke fewer cigarettes -- and with variation across cultural and ethnic groups," said Saul Shiffman, Ph.D., professor of psychology at University of Pittsburgh. "The groundbreaking 'Time to First Cigarette' dosage selector ensures the user gets the appropriate level of nicotine to help the user quit."
Similar to Nicorette nicotine gum and NicoDerm CQ nicotine patch, the Commit Lozenge helps relieve craving and nicotine withdrawal symptoms by providing a temporary alternative source of nicotine, without exposing the quitter to the harmful tars and carbon monoxide from cigarette smoke. The Commit Lozenge goes to work after you place it in your mouth, releasing nicotine as it dissolves to effectively reduce cravings. The quitter uses fewer and fewer lozenges during the 12-week program until he/she is completely nicotine-free.
The 72-count Commit Lozenge packs will include a comprehensive user's guide that explains the process of quitting, how the Commit Lozenge works, the TTFC dosage method, specific tips for quitting and advice about staying smoke-free. Purchasers of the Commit Lozenge also receive free enrollment in Committed Quitters, a personalized behavioral support program that, when compared to NRT alone, has been clinically proven (among participants who read or reviewed the CQP materials) to increase a smoker's chance of quitting successfully by up to 26 percent when paired with NicoDerm CQ and by up to 50 percent when paired with Nicorette.
Participants in the Committed Quitters program submit a detailed "smoking history" online or via telephone and receive a tailored profile and quitting program. A series of customized self-help materials is sent throughout the 12-week course of therapy to help users successfully cope with their specific triggers and issues in quitting. For more information about the Commit Lozenge, please visit http://commitlozenge.quit.com/.
The new Commit Lozenge will be available in 2mg and 4mg strengths by the end of November at many drug stores, mass merchandisers and supermarkets that carry a large selection of non-prescription health products. GlaxoSmithKline Consumer Healthcare, marketer of the Commit Lozenge, plans to communicate the availability of the new product through extensive advertising, consumer and event promotion, as well as public relations initiatives.
The Commit Lozenge is yet another option for stopping smoking available from GlaxoSmithKline Consumer Healthcare, the providers of original, mint- and orange-flavored Nicorette nicotine gum and original and Clear NicoDerm CQ nicotine patch.
With the 1996 launches of both Nicorette and NicoDerm CQ, GlaxoSmithKline became the first company to offer OTC nicotine replacement therapy for smokers who want to quit. For more information about the new Commit Lozenge, original, mint- and orange-flavored Nicorette gum or original and Clear NicoDerm CQ patch, visit http://www.quitnet.com. For more information about original, mint- and orange-flavored Nicorette gum or original and Clear NicoDerm CQ patch, visit http://www.quitnet.com. For more information about the Committed Quitters program, please visit http://www.committedquitters.com.
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.
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FACTS ABOUT: COMMIT(tm) LOZENGE
* The Commit(tm) Lozenge is an effective new treatment for smoking cessation that helps control cravings. This is the first and only nicotine replacement therapy (NRT) in the form of a lozenge. It provides smokers with craving fighting medicine to help them control cravings and to manage their quit attempts. The Commit Lozenge was approved by the Food and Drug Administration (FDA) in October 2002 and will be available for over-the-counter (OTC) sale by the end of November.
HOW THE COMMIT LOZENGE WORKS
* The Commit Lozenge helps reduce withdrawal symptoms by providing a temporary alternative source of nicotine, without exposing the quitter to the harmful tars and carbon monoxide from cigarette smoke.
* The Commit Lozenge is simple to use. It goes to work after you place it in your mouth, effectively reducing cravings by delivering craving-fighting medicine fast. The quitter uses fewer and fewer lozenges during the 12-week program, until he/she is completely nicotine-free.
DOSING/THERAPY
* The Commit Lozenge uses a groundbreaking new method for smokers to determine their degree of physical dependence on nicotine, which helps them tailor their quit attempt. This new indicator is called "Time To First Cigarette" (TTFC).
* With TTFC, those who smoke their first cigarette within 30 minutes of waking up should take/use the 4mg strength of the Commit Lozenge, whereas those who smoke their first cigarette after 30 minutes of waking require the 2mg strength.
* Leading experts regard TTFC as one of the best indicators of dependence because all smokers wake up in a state of nicotine deprivation, and the drive to quickly self-administer is a strong indicator of nicotine dependence.
* TTFC reflects the quitter's need to replenish nicotine levels, which is what NRT, including the Commit Lozenge, helps to do. Therefore, using TTFC means that smokers get the appropriate strength for their needs.
* It is recommended that during the first six weeks of his/her quit attempt, an individual should take one lozenge every one-to-two hours. This dosage is then reduced to one lozenge every two-to-four hours in weeks seven though nine and every four-to-eight hours in weeks 10 through 12. By following these usage instructions, an individual should be able to obtain enough nicotine to reduce his/her cravings and withdrawal symptoms throughout their quit attempt.
* The recommended length of therapy for the Commit Lozenge is 12 weeks.
* The Commit Lozenge will be available in 72- and 168-count packs. The Commit Lozenge pack will include a comprehensive user's guide that explains the process of quitting, how the Commit Lozenge works, the TTFC dosing method, specific tips for quitting and advice about staying smoke-free.
PRICING/AVAILABILITY
* For the recommended full 12-week course of therapy, the retail cost of the Commit Lozenge is approximately equal to what a smoker spends buying a pack of cigarettes per day over the same period of time.
* The Commit Lozenge will be available in 2mg and 4mg strengths by the end of November at many drug stores, mass merchandisers and supermarkets that carry a large selection of non-prescription health products.
THE COMMITTED QUITTERS PROGRAM
* Purchasers of the Commit Lozenge receive free enrollment in Committed Quitters¥, a personalized behavioral support program available online and by telephone.
QUITTING WITH SUPPORT
* Recent studies suggest that receiving support from family and friends, or becoming involved in a "buddy system," is important in helping smokers stay motivated and can, therefore, increase a smoker's chance of quitting.
PROPER USE
* It is important that users refer to the package for the following dosage and proper use instructions:
- Stop all smoking when beginning therapy with the Commit Lozenge.
- Do not eat or drink for 15 minutes before using the Commit Lozenge. (Some beverages can reduce the effectiveness of the Commit Lozenge.)
- Suck on the Commit Lozenge until it dissolves. Do not bite or chew it like a hard candy, and do not swallow it.
- Stop using the Commit Lozenge after 12 weeks. If you still feel the need to use the Lozenge, talk to your doctor.
- Do not use the Commit Lozenge if you continue to smoke, chew tobacco, use snuff or any other product containing nicotine (e.g., nicotine patch or gum).
Ask a doctor before you use the Commit Lozenge if you:
- are under the age of 18.
- have a history of heart disease, an irregular heart beat or had a recent heart attack. Nicotine can increase your heart rate.
- have high blood pressure not controlled with medication. Nicotine can increase your blood pressure.
- are currently taking prescription medication for depression or asthma.
* If you are pregnant or breast feeding, only use this medicine on the advice of your health care provider. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known.
* Keep out of reach of children and pets.
For more information about the Commit Lozenge, visit http://commitlozenge.quit.com/. For information about original, mint and orange-flavored Nicorette(r) nicotine gum and original and Clear(tm) NicoDerm(r) CQ(r) nicotine patch, visit http://www.quitnet.com.
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