Nicotine Spray Gets FDA Approval


WASHINGTON--1997 -- The Food and Drug Administration (FDA) just approved the first prescription nicotine nasal spray as a treatment for adults trying to quit smoking.

Smoking is a known addiction and tobacco smoke contains nicotine, a drug that is addictive and can make quitting difficult for smokers. Smoking accounts for nearly one third of cancer deaths and most lung cancer deaths.

In reviewing trials of the spray, the FDA noted that 25 percent of the patients using the nicotine spray stopped smoking for at least one year. In comparison, only 13 percent of the patients who were given a placebo stopped for this period. This rate of effectiveness was comparable to that of other smoking cessation products, like patches or gum.

It was also noted that all patients in the trials simultaneously received additional supportive therapy, such as counseling.

Nicotine is a drug that is known to be addictive. Therefore, the nicotine spray is not recommended for longer than six months.

The nicotine nasal spray can irritate the nose or sinuses and is not recommended for patients with underlying conditions involving these areas, such as asthma or allergies. The product is not recommended for children.

The nicotine nasal spray will be marketed by McNeil Pharmaceutical under the brand name of Nicotrol NS.

Related to the above, the editors of MedicineNet add the following facts from the National Institutes of Health:

  • Smoking is a major cause of heart and blood vessel disease.
  • Smoking has been shown to harm not only the smoker, but also those nearby who breathe the tobacco smoke.
  • Pregnant women who smoke are more likely to deliver babies with abnormally low birth weights.
  • Children of smoking parents are more likely to require hospital care for bronchitis and pneumonia than children of nonsmoking parents.
  • Children of smoking parents often become smokers themselves.

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