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| |  NicoDerm CQ Now Available Over-the-Counter PITTSBURGH, Aug. 16, 1996 -- Smokers who want to quit will have a new option available to help them through the process when NicoDerm(R) CQ(TM) hits retail shelves today. NicoDerm CQ will be the first and only nicotine patch available over-the-counter (OTC) that offers its complete prescription regimen and allows a simple step down process to gradually reduce nicotine intake. In addition, NicoDerm CQ will be the only OTC nicotine patch available in partnership with the American Cancer Society (ACS). NicoDerm was the most widely prescribed nicotine patch in the U.S., and has been used safely and effectively by more than four million smokers since its introduction in 1991. "SmithKline Beecham created the OTC nicotine replacement category with the introduction of Nicorette, and we understand the cessation process," said George Quesnelle, Vice President and Director, Medical Marketing and Sales, SmithKline Beecham (NYSE: SBH) Consumer Healthcare. "Not all smokers are created equal. Because there are vast differences between smokers, an effective smoking cessation program must offer flexibility and appeal to many 'smoking styles.' NicoDerm CQ can be used safely by all smokers." NicoDerm CQ Patch The NicoDerm CQ patch begins working within 15 to 30 minutes of application. When the patch is affixed to the skin, nicotine is absorbed by the body through a special rate-controlling transdermal membrane. The patented technology of this layer delivers a steady level of nicotine throughout the day to reduce the cravings associated with withdrawal. The NicoDerm CQ patch resembles a simple adhesive bandage and is applied as such. It is the smallest transdermal nicotine patch available, and it consists of a thin, flexible system in four layers: an impermeable backing, a drug reservoir, a rate-controlling membrane and an adhesive. NicoDerm CQ offers a simple step down program to gradually reduce a smoker's dependence on nicotine over the 10-week treatment period. Smokers are instructed to begin at Step 1, using a 21mg patch each day for six weeks. During Step 2, a 14mg patch is used daily for two weeks, followed by Step 3, (7mg) for the remaining two weeks. This tapering of nicotine levels is an important component of the NicoDerm CQ smoking cessation program, because it allows smokers to decrease their dependence on nicotine slowly, the way physicians prefer. Recent government guidelines for the treatment of smoking cessation, issued by the Agency for Health Care Policy and Research (AHCPR), recommend the use of nicotine replacement therapies (NRT) that allow users to gradually reduce their nicotine intake. NicoDerm CQ is the only OTC nicotine patch to offer tapering. Light smokers, who smoke 10 or fewer cigarettes per day, may begin the program at Step 2 (14mg) for six weeks and Step 3 (7mg) for two weeks, then stop. According to the Centers for Disease Control and Prevention (CDC), in 1994, approximately 38 percent of all smokers were light smokers. With NicoDerm CQ, smokers can choose to either apply the patch for up to 24 hours or they may remove the patch after 16 hours (before going to sleep). This flexibility allows smokers to wear the patch throughout the night, since many people experience intense morning cravings. American Cancer Society Partnership Smoking is the number one preventable cause of death in the United States, yet approximately 46 million Americans continue to smoke. With all of the health warnings and programs to educate the public about the hazards of smoking, Americans continue to light up everyday. Sharing a mutual dedication to provide smokers with support and educational information about the quitting process, the American Cancer Society and SmithKline Beecham have teamed up to help guide quitters through the process. "We are confident that our partnership will strengthen efforts to provide smokers with a powerful, customized method and the support needed in the quitting process," said Harmon Eyre, M.D., Executive Vice President for Research and Cancer Control of the American Cancer Society. "This educational partnership will provide smokers who are thinking about quitting with easy access to the support materials they need to successfully manage their quit attempts." Committed Quitters Program While using NicoDerm CQ, a smoker also has the option of participating in the customized behavioral support program called "Committed Quitters." The program is designed to provide tailored counseling and individualized quitting tips based upon specific responses provided by the individual during a telephone interview with a Committed Quitters operator. "The opportunity to join a support program like Committed Quitters optimizes a smoker's chance of successfully quitting," said John Hughes, M.D., Professor, Department of Psychiatry, Psychology and Family Practice, University of Vermont. "Research demonstrates that a habitual smoker is more likely to abstain if he or she is following a treatment plan that addresses both the physical and psychological aspects of addictive behavior." Based on the responses from those previously using prescription NicoDerm, people enrolled in Committed Quitters were more than twice as likely to successfully quit smoking than those people only using the patch. The NicoDerm CQ kit includes seven (or 14) patches; a child-resistant disposal tray; a User's Guide; an audiocassette (in both Step 1 packs and Step 2); and a coupon for free enrollment in the Committed Quitters program (in both Step 1 packs and in Step 2). Depending upon the retailer, the Step 1 kit with Committed Quitter materials will cost about $50. Certain populations should seek the advice of a health professional prior to starting therapy with nicotine patches. These include patients under age 18; people with heart disease, an irregular heartbeat or who have had a recent heart attack; pregnant women; people with high blood pressure not controlled with medication; people taking prescription medicine for depression or asthma; or people with skin disease, rashes or who are allergic to adhesives. The most frequently reported adverse events associated with the use of nicotine patches are usually mild and include short-lived itching or burning at the site of application and dizziness. The OTC approval of NicoDerm CQ closely follows the FDA approval of SmithKline Beecham's Nicorette(R) nicotine chewing gum, making it the company's second nicotine replacement therapy to be available without a prescription. SmithKline Beecham's Tagamet(R) HB(TM), for the symptomatic relief of heartburn, acid indigestion and sour stomach, was also approved for OTC sale less than one year ago. NicoDerm was developed by ALZA Corporation (NYSE: AZA) and marketed as a prescription product by Hoechst Marion Roussel. SmithKline Beecham Consumer Healthcare will be responsible for the marketing of NicoDerm CQ in a joint venture with Hoechst Marion Roussel. SmithKline Beecham -- one of the world's leading healthcare companies -- discovers, develops, manufactures and markets pharmaceuticals, vaccines, over-the-counter medicines, health-related consumer products and healthcare services including clinical laboratory testing, disease management and pharmaceutical benefit management.
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