FDA Approves Nicotine Nasal Spray

Smokers wanting to kick the habit will soon be able to try a nicotine nasal spray that is stronger than nicotine gum and more powerful than nicotine patches.

The Food and Drug Administration approved the spray, which is designed to quell the cigarette cravings of those attempting to quit smoking by delivering a nicotine concentration with each inhalation.

The spray, to be sold with a doctor’s prescription under the name Nicotrol, enters the bloodstream rapidly after each inhalation.

Three controlled clinical trials involving more than 700 patients showed that about 25% of the patients using the spray were successful in quitting smoking for at least one year. Of the patients receiving a placebo, only 13% were able to quit. The FDA concluded that the success rate of the spray is comparable to other smoking-cessation products such as the patch and gum. Beginning next month, nicotine gum will be available without a prescription.

But scientists have cautioned the FDA about the spray’s potential addictive quality and have recommended that strong warnings accompany the sale of the drug. The FDA is recommending that the spray be used over a three-month period, and--because the chances of dependency on the spray increase over time--the agency also strongly advises that it should never be used more than six months.

The FDA also has asked Pharmacia, the spray’s manufacturer, to establish and implement a marketing and surveillance plan to monitor unexpected adverse effects. “This is a concern of ours,” said Ivy Kupec, a spokesperson for the FDA.

FDA scientists reported that in one case a woman in a three-month clinical trial suffered a nasal ulcer after using the spray for more than a year.

Smokers will be instructed to inhale one squirt of the spray an hour in each nostril, with each dose containing 1 milligram of nicotine. The pump bottle will hold a total of 100 milligrams of the nicotine solution, and warnings will alert patients that 40 milligrams taken at once can be lethal.

Although most of the patients using the nicotine spray in the trial program experienced nasal or sinus irritation, the FDA stops short of recommending the product solely for hard-core smokers. But, because of these side effects, the spray will not be recommended for people with underlying nasal or sinus conditions, allergies or asthma, FDA officials said in a statement.

The spray will be available by prescription later this year, according to McNeil Pharmaceuticals, which is licensed to sell the product. Its price has not been set.