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What is the COMMIT Lozenge?
The COMMIT Lozenge is an effective treatment for smoking cessation that helps control cravings by delivering craving-fighting medicine fast. The COMMIT Lozenge has been shown to be effective in helping people quit, including smokers who have tried quitting before. They are a sugar-free, compressed tablet type of lozenge that contain either 2 mg or 4 mg of nicotine. The COMMIT Lozenge combines a new form, a unique, groundbreaking dosage-selector method, a structured step-down dosing schedule, and a personalized stop-smoking behavioral support program.
How does the COMMIT Lozenge work? Does it work like the gum?
The COMMIT Lozenge is simple to use. It goes to work after you place it into 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.
Like Nicorette gum, 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. Those who use Nicorette gum employ a specific technique (i.e., "chew, chew, park") in order to use the product properly. COMMIT is meant to be sucked on and moved from side to side until it dissolves in your mouth, just like a regular lozenge.
Both the 2 mg and 4 mg COMMIT Lozenge are clinically proven to significantly reduce both cravings and withdrawal symptoms including irritability, anger, frustration, and anxiety (Ref: Data on file, GSK).
What is the proper way to use the COMMIT Lozenge?
The COMMIT Lozenge is meant to be sucked on and moved from side to side until it dissolves. A person should not bite into or chew on the lozenge and it should not be swallowed.
How does a smoker know whether to use the 2-mg or 4-mg dosage of therapy?
The COMMIT Lozenge offers a groundbreaking new method for smokers to determine their degree of physical dependence on nicotine. This new indicator is called "Time To First Cigarette." With "Time to First Cigarette, " those who smoke their first cigarette within 30 minutes of waking are directed to use the 4-mg strength of COMMIT, whereas those who smoke their first cigarette after 30 minutes of waking are directed to use the 2-mg strength. Leading smoking cessation experts regard "Time To First Cigarette" 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.
Does COMMIT work better than other stop smoking tools available (eg, nicotine patch, gum, inhaler, Zyban®)?
No head-to-head studies comparing the efficacy of the COMMIT Lozenge and other stop-smoking pharmacotherapies, such as the nicotine patch and gum, have been conducted.
Efficacy is best gauged in relation to the individual smoker. Almost three out of four smokers are interested in quitting, and what works for one may not work for another . (Ref: CDC, 1995) Therefore, an effective smoking cessation program must offer flexibility and appeal to many "smoking styles." Each person needs to find a plan that works best for him/her. Tapering nicotine levels is an important component of quitting, because it allows smokers to slowly decrease their dependence on nicotine. COMMIT offers a flexible program that allows users to reduce their nicotine dosage.
Clinical studies with the COMMIT Lozenge demonstrate significant success versus placebo even among the toughest categories of smokers; eg, those who have tried to quit with medication and failed, as well as heavily addicted smokers who smoke their first daily cigarette within 30 minutes of waking.
Is the COMMIT Lozenge stronger than other forms of NRT, such as the gum or the patch?
No head-to-head studies comparing the efficacy of the COMMIT Lozenge and the other stop-smoking pharmacotherapies, such as the nicotine patch and gum, have been conducted.
Efficacy is best gauged in relation to the individual smoker. Almost three out of four smokers are interested in quitting, and what works for one may not work for another . (Ref: CDC, 1995) Therefore, an effective smoking cessation program must offer flexibility and appeal to many "smoking styles." Each person needs to find a plan that works best for him/her. Tapering nicotine levels is an important component of quitting, because it allows smokers to slowly decrease their dependence on nicotine. The COMMIT Lozenge offers a flexible program that allows users to reduce their nicotine dosage.
What makes COMMIT different from other stop smoking tools available?
First, the COMMIT Lozenge is a unique stop smoking tool. This is the first and only nicotine replacement therapy (NRT) in the form of a lozenge. The COMMIT Lozenge also offers a novel dosage-selection tool called "Time to First Cigarette. " With "Time to First Cigarette, " those who smoke their first cigarette within 30 minutes of waking are directed to use the 4-mg strength of the COMMIT Lozenge, whereas those who smoke their first cigarette after 30 minutes of waking are directed to use the 2-mg strength. Leading stop smoking experts regard "Time to First Cigarette" 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.
Finally, unlike other NRT products, there is no need to dispose of the COMMIT Lozenge, because it dissolves completely in the user's mouth.
What does the COMMIT Lozenge taste like?
The COMMIT Lozenge is a medicine, not a candy. It has a light mint flavor and delivers a warming tingle as the lozenge begins to release medicine. The medicine helps smokers fight their cravings. Accordingly, the COMMIT Lozenge slight tingling in the mouth can give a peppery taste that is a signal that the lozenge is working.
Can people who chew tobacco or dip snuff use NRT to quit?
No, the COMMIT Lozenge has been approved for treatment of tobacco dependence due to cigarette smoking.
What is the difference between your product and Star Scientific's Ariva?
The Ariva "cigalett" is a tobacco tablet that is consumed quickly. In contrast, the COMMIT Lozenge, a completely tobacco-free smoking cessation therapy, has undergone thorough clinical testing to demonstrate the product's safety and efficacy to the FDA. What's more, GSK's NRT products, including the COMMIT Lozenge, are intended to help people wean off their nicotine addiction until they are ultimately nicotine-free (Ref: Becoming a Nonsmoker brochure, 2000), while products like Ariva are designed to allow people to perpetuate their addiction to tobacco.
Are there any side effects to taking the COMMIT Lozenge?
The side effects seen in users of the COMMIT Lozenge are generally moderate and short-lived. The most common side effects are nausea, hiccups, coughing, heartburn, headache and flatulence.
The COMMIT Lozenge is not a candy, although you suck it in your mouth the same way. If the COMMIT Lozenge is consumed too fast or chewed and swallowed, a user may experience heartburn or indigestion. Lozenge users should discontinue use and consult their doctor if they experience mouth or teeth problems, irregular heartbeat or palpitations, or symptoms of nicotine overdose such as dizziness, weakness, and rapid heartbeat.
The COMMIT Lozenge can cause a peppery taste or a slight tingling in the mouth. This is a normal effect of the release of nicotine and is a signal that the lozenge is working.
Can the COMMIT Lozenge be used in conjunction with other forms of NRT?
No, you should talk to your doctor.
Can the COMMIT Lozenge be used in conjunction with Zyban?
The FDA has not approved concomitant use of COMMIT and Zyban for treatment of smoking cessation. Consult your doctor.
Is the COMMIT Lozenge safe for pregnant women?
The labeling of GSK's NRT products, including that of the COMMIT Lozenge, advises: "If you are pregnant or breast-feeding, only use this medicine on the advice of your healthcare 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.
Is the COMMIT Lozenge safe for people with heart disease?
People who have heart disease should see a doctor before using any NRT It should be noted that there is evidence that concludes NRT is much safer than cigarette smoking, even in people with active heart disease.
What about people with other medical conditions? Should people with certain conditions stay away from using the COMMIT Lozenge?
The following patient populations are instructed to see their doctor before using the COMMIT Lozenge: people under age 18; people with heart disease, an irregular heartbeat, or who have had a recent heart attack; people with high blood pressure not controlled with medication; people with stomach ulcers or diabetes, and people taking prescription medicine for depression or asthma. In these cases, a doctor can best determine whether the COMMIT Lozenge is appropriate.
Should people taking certain medications avoid using the COMMIT Lozenge?
Smokers undergo a physiologic change when they quit smoking by reducing exposure to the 4,000 chemicals contained in cigarettes. As a result, the smoker will see a difference in the way certain medications, such as theophylline, are metabolized, and the effect they have on the body. Therefore, smokers taking a prescription medication are encouraged to discuss their medications with their doctor. The doctor can adjust a patient's prescription medication dose, as needed.
How long is the course of treatment for the COMMIT Lozenge?
The COMMIT Lozenge features a structured step-down dosing schedule that ensures users will reduce their nicotine intake across 12 weeks, until the course is completed and they have overcome their dependence.
Can people become addicted to the lozenge?
Smokers are already addicted to the nicotine as delivered in cigarettes when they start therapy. The COMMIT Lozenge lets them wean off their nicotine addiction, until they are ultimately nicotine-free.
NRT is proven to be safe and effective for people who are motivated to use it to quit smoking. There is no evidence that NRT has been the route by which non-smokers have become addicted to nicotine.
Is it safe to use the COMMIT Lozenge for longer than the 12-week recommended course of therapy?
GlaxoSmithKline advises users to follow the directions on the COMMIT labeling which state, "stop using the Commit Lozenge at the end of 12 weeks. If you still feel the need to use the lozenge, talk to your doctor."
How many lozenges are people advised to take per day?
During the first 6 weeks of his/her quit attempt, an individual should take one lozenge every 1 to 2 hours. This is then reduced to one lozenge every 2 to 4 hours in weeks 7 to 9 and every 4 to 8 hours in weeks 10 to 12. By following these usage instructions, an individual will be able to obtain enough nicotine to reduce his/her craving and withdrawal symptoms throughout their quit attempt. Do not use more than 5 lozenges in six hours.
The label encourages users to use at least 9 lozenges minimum per day during the first 6 weeks of their quit attempt. Those who complied with the recommended dosing schedule did considerably better than those who did not. Quitters are advised not to use more than 20 lozenges per day.
Would it be dangerous to take more than the recommended amount? How many would constitute an overdose?
The dosage instructions for the COMMIT Lozenge clearly state that only one lozenge should be used at a time. A person should not exceed 20 lozenges a day with either the 2-mg or 4-mg lozenges.
If a person exceeds the maximum recommended dose of COMMIT in a 24-hour period, symptoms of a nicotine overdose may occur. Symptoms of nicotine overdose include nausea, vomiting, dizziness, diarrhea, weakness, and rapid heartbeat. If this occurs, the user should discontinue use and see a doctor. A doctor can determine when and if to restart/continue use.
Where did the "Time to First Cigarette" measure come from?
The biological basis for the "Time to First Cigarette" dosage method is that smokers awaken in the morning with low levels of nicotine in their system and are in a state of nicotine withdrawal. For this reason, how quickly they smoke their first cigarette is a very logical and powerful indicator of their level of nicotine dependence. "Time to First Cigarette" reflects the quitter's need to replenish nicotine levels, which is what the lozenge helps to do. The unique "Time to First Cigarette" dosing plan is tailored to help the user quit.
Should people using the nicotine gum or patch use this measure as well? Why not?
No. People using the patch or gum should continue to follow the products' labeling, which instructs users to determine dosage according to the number of cigarettes smoked per day.
(Why not?)
These products are designed to be used in conjunction with the "number of cigarettes per day" dosage method. Both Nicorette and NicoDerm CQ have undergone extensive clinical testing and have been proven to be effective using this type of dosage measurement tool.
Will highly dependent smokers feel the need to consume more lozenges throughout the day despite this new dosage measure?
The recommended dosing schedule for the COMMIT Lozenge is proven effective in heavily dependent (ie, "Time to First Cigarette" within 30 minutes of waking) smokers. As such, no changes to the dose are required.
Can a user switch from 4 mg to 2 mg through the course of treatment?
No. Users should simply reduce the number of lozenges they take per day as they progress through their quit attempt. During the first 6 weeks of their quit attempt, an individual should take one lozenge every 1 to 2 hours. This is then reduced to one lozenge every 2 to 4 hours in weeks 7 to 9 and every 4 to 8 hours in weeks 10 to 12.
Is the COMMIT Lozenge safe for people under the age of 18 who want to quit smoking?
GlaxoSmithKline is committed to ensuring that people under the age of 18 do not use the COMMIT Lozenge unless directed by a physician.
This product has not been tested for safety and efficacy in this population, so direct data are not available.
Is there a concern that the COMMIT Lozenge might be mistaken for candy?
GlaxoSmithKline's first priority is the safety of our customers, which includes taking precautions to keep these medications away from minors. To that end, we have ensured that the lozenge blister card and our packaging meet all child-resistant guidelines. In addition, GSK works with retailers to ensure that they know the product is serious medication for people over 18, and do not sell it to teens or children. With more than five years of over-the-counter availability and no major reports of misuse or abuse, we believe any incident of a minor using NRT is the exception, not the rule.
Adults quitting smoking in a household with children should explain to the children that the adult is using a serious medicine to help stop smoking. The adult also can use this opportunity to advise children against smoking and hopefully be a positive, smoke-free role model with the child.
How will GlaxoSmithKline keep teenagers from buying the COMMIT Lozenge and abusing it?
The COMMIT Lozenge does not have any inherent appeal among teens and no characteristics for teen "fad" use, such as an immediate "euphoric" effect. Additionally, the cost of the product makes it unlikely that teens would want to use it.
GSK already has in place a program of retailer education and has established incentives designed to ensure that the COMMIT Lozenge is not sold to persons under the age of 18. GSK also has developed a comprehensive post-marketing surveillance strategy to help identify and correct any such off-label use.
How much does the COMMIT Lozenge cost? Is that cheaper or more expensive than other forms of NRT?
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. Specifically, the average retail price for a 72-count box is approximately $40Ñprices can vary depending on the store. So, the average daily cost of using nine COMMIT Lozenges per day is about $5 during the 12 weeks of therapy. Of course, after the 12 weeks of therapy, the savings from not buying cigarettes could really add up for a non-smoker.
How many lozenges are sold in a package?
The COMMIT Lozenge is sold in 72-count and 144-count packs.
Is the COMMIT Lozenge more effective than Nicorette gum or the NicoDerm CQ patch?
No head-to-head clinical studies comparing the efficacy of the COMMIT Lozenge and other stop-smoking pharmacotherapies, such as the nicotine patch and gum, have been conducted.
Efficacy is best gauged in relation to the individual smoker and their smoking style. Almost three out of four smokers are interested in quitting, and what works for one may not work for another.
Is the COMMIT Lozenge more effective than Zyban?
Both products have been proven to be effective in their respective clinical studies. It is not possible to determine relative efficacy without head-to-head clinical studies comparing the COMMIT Lozenge to prescription products and these have not been conducted
Will any support programs be offered to people who use the COMMIT Lozenge?
The personal support program "Committed Quitters," which currently is available as a free support program to people using Nicorette and NicoDerm CQ, has been adapted for the COMMIT Lozenge. "Committed Quitters" is an individualized plan for smokers based on specific reasons they have for wanting to quit and the barriers that prevent them from quitting.
What makes the Committed Quitters Program (CQP) an important part of a smoking cessation effort?
Quitting smoking involves treating both the physical addiction to nicotine and the psychological habits associated with smoking. The objective of the CQP is to maximize the success of COMMIT Lozenge users by providing convenient, tailored counseling, as well as information about becoming nicotine-free. This creates a "one-two punch," giving smokers a better opportunity to succeed.
How does a smoker enroll in the Committed Quitters Program?
Smokers can enroll by visiting the Committed Quitters website, www.CommittedQuitters.com, or if they don't have access to the Internet, then by calling a toll-free number. Enrollees will be asked a series of questions to gather relevant, personal information that will be used in all of the tailored communication materials. This personal information includes the smoker's name and address, quit date, motives for quitting and barriers to success, and time to first cigarette.
Does the Committed Quitters Program help improve the odds for a successful quit attempt?
While no studies comparing the success rates of those who use the COMMIT Lozenge alone with those who use COMMIT in conjunction with the Committed Quitters program have been conducted, previous studies show that the Committed Quitters program significantly improves success rates among users for Nicorette and NicoDerm CQ. So, since the individually tailored support programs generally do increase chances of success, GSK offers the free Committed Quitters program to users of the COMMIT Lozenge as well.
When should I recommend COMMIT to my patients instead of Nicorette or NicoDerm CQ?
The COMMIT Lozenge, Nicorette, and NicoDerm CQ are effective first-line therapies for smokers trying to quit. And, of course, the Clinical Practice Guideline for Treating Tobacco Dependence recommends pharmacotherapy to every smoker unless contraindicated.
Also, the COMMIT Lozenge is clinically proven to be effective for even the toughest category smokers, such as those who have previously made an assisted quit attempt and failed, as well as the heavily addicted smokers; ie, those who smoke their first cigarette of the day within 30 minutes of waking. So, for proven help, recommend COMMIT because it delivers powerful, fast craving control for even the toughest smokers.
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