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Nicotine Nasal Spray Safe, Effective

NEW YORK (Reuters) -- New nasal spray nicotine replacement therapies work faster than nicotine patches to reduce the urge to smoke, researchers say. But they say the sprays, which have not yet gained Food and Drug Administration approval, can produce irritating, though transitory, side effects among many users.

"Nicotine nasal spray seems to be safe and effective," conclude researchers led by Dr. Richard Hurt of the Mayo Clinic in Rochester, Minnesota.

Their study, published in the current issue of the journal Mayo Clinic Proceedings, focused on the experience of 50 adult smokers whose pre-treatment cigarette consumption averaged more than a pack per day.

Each of the smokers (who the researchers say considered themselves "motivated" to stop smoking) were asked to try the nasal sprays over a period of 8 weeks. The recommended 1 - 2 milligram (mg) dosage was administered an average of 15 times per day per patient. The Mayo researchers suggested that the study participants begin to gradually reduce their use of the nasal therapy after the 6th week.

Comparing their results with those of a similar 1994 patch-based study, the researchers conclude that "the rate of initial and long-term abstinence from smoking was comparable to that attained with use of a 22-mg nicotine patch daily... (at) approximately 50%." They point out that abstinence rates remained high even though the total amount of nicotine administered via the spray therapy "was less than (that) commonly observed with nicotine patch therapy."

They also note that the relatively quick absorption of the spray through the nasal lining helped suppress nicotine withdrawal symptoms within 15 minutes after use, compared with the several hours usually required when using patch methods.

However, the investigators say they "found an increase in five symptoms (runny nose, nasal irritation, throat irritation, watering eyes, and sneezing)" among many of the study subjects. Most of these side effects tapered off by the end of the first week of treatment, however, and only 2 of the 50 subjects felt their side effects warranted the discontinuation of spray therapy.

SOURCE: Mayo Clinic Proceedings (1998;73:118-125)


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