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 experienced by those attempting to quit smoking and which delivers nicotine with each inhalation.
The spray, to be sold as a 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 percent of the patients using the spray were successful at quitting smoking for at least one year. Of the patients receiving a placebo, only 13 percent of the patients 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, the 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 time period, and because the chances of dependency increase over time, the FDA is also strongly advising its use should never exceed six months.
The FDA has also asked Pharmacia, the spray’s manufacturer, to implement a marketing and surveillance plan to monitor any unexpected effects.
FDA scientists reported that in one extreme case, a woman in the three-month clinical trial suffered a nasal ulcer after using the spray for over a year. The woman reportedly watered down her last supply to make it last longer and eventually returned to smoking cigarettes.