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| |  NICOTROL NS Nicotine Nasal Spray Cleared for U.S. Marketing FORT WASHINGTON, Pa. -- March 26, 1996 -- McNeil Consumer Products Company announced today that NICOTROL(R) NS, a prescription nicotine nasal spray, was cleared for marketing by the U.S. Food and Drug Administration. NICOTROL NS, the first nicotine nasal spray to be introduced in the United States, is indicated as an aid to smoking cessation for the relief of nicotine withdrawal symptoms. As with all nicotine replacement therapy, NICOTROL NS is to be used with a comprehensive behavior modification system. NICOTROL NS will be marketed with the Pathways to Change(R) behavior change program. The novel delivery form of NICOTROL NS distinguishes it from other nicotine replacement therapies currently on the market. The new product delivers nicotine to the nasal membranes, providing fast relief of nicotine craving to help smokers reduce the cravings that can derail quit attempts. The NICOTROL NS Nasal Spray offers benefits for heavier smokers due to its flexible dosing schedule and prompt onset of action. McNeil Consumer Products Company will distribute and market the spray under the brand name NICOTROL as a prescription product under license from Pharmacia & Upjohn Consumer Healthcare, who holds the NDA. McNeil also markets the NICOTROL(R) TD nicotine transdermal system. "The availability of the NICOTROL NS Nasal Spray is an important new option for doctors and patients battling smoking addiction. It will complement other prescription and over-the-counter therapies on the market, and we expect it to be a welcome new therapy for smokers who have tried to quit before," said Brian D. Perkins, president of McNeil Consumer Products Company. "The U.S. launch of NICOTROL NS is an important step in our global effort to provide a broad and efficacious range of nicotine replacement products supporting the needs of individual smokers. We are confident that NICOTROL NS will enable the doctor to provide an effective treatment for heavily nicotine dependent smokers," said Jorgen Johnsson, President of Pharmacia & Upjohn Consumer Healthcare. NICOTROL NS was shown to be effective in helping smokers quit in three clinical studies involving 730 patients. Between 31 and 35 percent of nasal spray users were smokefree at the end of six months. According to six month data, on average, only 12 to 15 percent of unaided smokers realize a successful quit attempt. NICOTROL NS Nasal Spray offers a new smoking cessation option for smokers who have tried to quit before, and may be especially appropriate for heavily dependent smokers. NICOTROL NS has dependence potential intermediate between other nicotine based therapies and cigarettes. It is important that smokers be motivated to quit smoking and willing to work through some initial local irritant effects which are experienced by virtually all users. Although this local irritation was common, no serious drug related side effects were reported in the clinical studies. The most common side effects were: running nose, throat irritation, watering eyes, sneezing and cough. McNeil Consumer Products Company is an affiliate of Johnson & Johnson. -- Warning Information NICOTROL(R) NS (nicotine nasal spray) is indicated as an aid to smoking cessation for the relief of nicotine withdrawal symptoms. NICOTROL(R) NS should be used as part of a comprehensive behavioral smoking cessation program. -- Patients should be urged to stop smoking completely before using NICOTROL(R) NS. Patients should be told not to smoke or use other nicotine-containing products while under treatment with NICOTROL(R) NS. -- The specific effects of NICOTROL(R) NS treatment on fetal development and nursing infants are unknown. Therefore, pregnant and nursing smokers should be encouraged to attempt cessation using educational and behavioral interventions before using pharmacological approaches. -- Use of NICOTROL(R) NS is not recommended in patients with chronic nasal disorders or asthma (e.g. allergy, rhinitis, nasal polyps and sinusitis) since such use has not been adequately studied. -- The risks of nicotine replacement in patients with certain cardiovascular and peripheral vascular diseases should be weighed against the benefits of including nicotine replacement in a smoking cessation program for them. -- It is important to ask patients about any other medications they may be taking, because concomitant medications may need dosage adjustment (see Drug Interactions section of full prescribing information). The safety of treatment with NICOTROL(R) NS for periods longer than six months has not been established, and such use is not recommended.
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