Nicorette Cleared to be Marketed as an OTC Aid in Smoking Cessation

Nicorette Cleared to be Marketed as an OTC Aid in Smoking Cessation


PITTSBURGH, Feb. 9, 1996 -- SmithKline Beecham announced today that the U.S. Food and Drug Administration (FDA) has granted the company clearance to market Nicorette(R) (nicotine polacrilex) as an over-the-counter (OTC) aid in smoking cessation, making it the only FDA-approved quitting aid available without a prescription. The OTC nicotine gum product will be available in the same dosage strengths as the prescription product and will be at retailers in late spring.

"We're looking forward to launching the only OTC option in nicotine replacement therapy," said Jack Ziegler, executive vice president, SmithKline Beecham Consumer Healthcare. "According to surveys, 75 percent of smokers would like to quit, but 70 percent won't see a doctor to do so. Making Nicorette available without a prescription will increase access for people who are ready to quit smoking. But until Nicorette is available in stores, we strongly encourage people to see their doctor for a prescription."

Nicorette relieves withdrawal symptoms by providing a temporary alternative source of nicotine, thereby easing the transition for an individual committed to smoking cessation. The nicotine in Nicorette reaches the bloodstream more gradually and at lower doses than delivered by cigarettes. The gum controls nicotine cravings without the harmful tars and carbon monoxide from cigarette smoke. While Nicorette controls withdrawal symptoms, thus addressing the physical addiction of smoking, the individual works to control the social and psychological aspects of the smoking habit.

Said Ziegler, "It's important to remember that Nicorette alone won't make a smoker quit. He or she must decide to quit and stay committed to it. And Nicorette is proven to be an effective aid in getting people through this difficult process." A free brochure about what smokers need to know before they quit is available from SmithKline Beecham by sending a self-addressed stamped envelope to: "Quit Smoking," P.O. Box 731, Radio City Station, New York, NY 10101-0731.

Nicorette represents one of the most significant advancements in aiding smoking cessation and is the first nicotine replacement therapy (NRT) in the United States to make the prescription-to-non-prescription conversion. Nicorette will be available OTC in both prescription strengths, 2mg and 4mg.

"Smoking is the single greatest preventable cause of death," said Saul Shiffman, Ph.D., Professor, University of Pittsburgh, Department of Psychology. "Although we have made great strides in getting many people to quit, we need to do more to help the many smokers who remain addicted to nicotine. Quitting is a difficult process, and it often takes several attempts before a person succeeds. Making effective therapies available over-the-counter will help people quit by giving them the opportunity to start their cessation attempt when they choose. In the meantime, smokers who are ready to quit now should see their doctor."

Nicorette is marketed in more than 50 countries and is available without a prescription in 34 countries. It has been available by prescription in the United States for 12 years.

SmithKline Beecham -- one of the world's leading health care companies -- discovers, develops, manufactures and markets pharmaceuticals, over-the-counter medicines, health-related consumer products and clinical laboratory testing services.

CONTACT: Media Relations: Elisia Greiner, 212-872-8083, or Carla DeLuca, 212-872-8117, or Investor Relations contact: Richard Williams, 215-751-7002, all for SmithKline Beecham (SBH)


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