Feds approve nicotine lozenges

The U.S. Food and Drug Administration has approved a nicotine throat lozenge meant to help smokers kick the habit. The sweets will be sold in stores alongside similar gums and patches. Maker GlaxoSmithKilne says the over-the-counter lozenges will come in two strengths to provide smokers with a source of nicotine that helps them avoid cigarette cravings and withdrawal symptoms while they try to quit.From the GlaxoSmithKline:US Food and Drug Administration approves effective new tool to help smokers quit
Clinical studies show CommitTM Lozenge can help even smokers who have tried to quit before

Pittsburgh, October 31, 2002 — 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 CommitTM 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 CQ1 and by up to 50 percent when paired with Nicorette2.

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 www.commitlozenge.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 www.quitnet.com. For more information about the Committed Quitters program, please visit 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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