NEW YORK (Reuters) -- A government advisory committee has recommended the Food and Drug Administration (FDA) approve a nicotine inhaler as a safe, effective way for smokers to kick the habit.
"The Nicotrol Inhaler offers a new and innovative smoking cessation option for smokers who find it difficult to quit because of their dependence on the 'ritual' of smoking," said Brian Perkins, president of the McNeil Consumer Products Company, which hopes to market the inhaler.
The device is made of plastic and resembles a fat cigarette. A small nicotine-impregnated cartridge is inserted into the mouthpiece, saturating inhaled air with nicotine. Most of the nicotine is absorbed into the bloodstream via the lining of the mouth, according to the manufacturer. Less than 5% is absorbed in the lungs.
"Many smokers complain that they miss the cigarette and all the behaviors that go with it -- taking it out of the pack, lighting it, putting it to the lips... inhaling and holding it," says Dr. Karl Olov Fagerstrom of Pharmacia and Upjohn, which developed the device.
In contrast to cigarettes, which deliver nicotine to the brain via the lungs and arteries, nicotine in the inhaler is introduced via the heart and veins, where it is diluted with freshly oxygenated blood. Smoke-delivered nicotine reaches the brain in concentrations 4 to 10 times higher than nicotine delivered by the inhaler, according to the manufacturer.
"Each puff of the inhaler contains 8 to 10 times less nicotine than a puff of a cigarette," manufacturers claimed. And the inhaler contains none of the tars, carbon monoxide, and other carcinogens found in cigarettes.
Results of clinical trials submitted to the advisory committee have shown that the inhaler doubles the one-year success rate of smokers trying to quit, compared to those using a placebo. Side effects included mouth and throat irritation, and coughing after inhalation.
If the inhaler is approved, McNeil plans to make it available by prescription only.
The inhaler is already approved for sale in Denmark, Sweden and Italy, and approval is pending in five other European countries.
