NEW YORK, May 06 (Reuters) -- The Food and Drug Administration (FDA) has approved a cigarette-shaped nicotine replacement therapy (NRT) which mimics the smoking 'ritual' as it helps smokers kick the habit.
"This nicotine replacement product delivers NRT like products already on the market," said FDA spokesperson Maureen Knippen, "but delivers its nicotine dose through a cartridge that the person inhales from."
The Nicotrol Inhaler, which met FDA approval Monday, will be available -- by prescription only -- later this year.
McNeil Consumer Products, which markets the Inhaler, says it discovered "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, sucking, inhaling and holding it." They say inhaling a small dose of nicotine (supplied by a cartridge inside the Inhaler's cigarette-like tube) "provides a sensation in the back of the throat similar to the feeling of inhaling from a cigarette."
However, McNeil says the new device provides "8 to 10 times less nicotine than a puff of a cigarette, with none of the tars and other harmful components of cigarettes."
The inhaled nicotine enters the bloodstream via the mouth and gums, not the lungs (as happens during actual smoking). Nicotine absorption through the lungs "explains the 'nicotine spike' that smokers feel almost instantly as they draw on a cigarette," according to a statement from McNeil Consumer Products. "This spike also accounts for the high abuse potential of tobacco products."
Does the new inhaled delivery system give prospective ex-smokers an added advantage in quitting? The FDA aren't sure. "To date, the product's ability to satisfy smokers' psychological needs for the hand/mouth ritual of smoking is unknown," Knippen said, adding that "in clinical trials, quit rates were comparable to other smoking cessation products already on the market."
McNeil instructs Inhaler users to begin therapy with "6 to 16 cartridges throughout the day to help control urges to smoke." This amount is to be gradually reduced over time. "Total treatment should not exceed six months," they say.
Both the FDA and NRT manufacturers agree that clinical trials have proven that use of the Inhaler (as well as other NRT products such as gums and patches) more than doubles the average smokers' chance of butting out for good, when compared with simply going 'cold turkey.'
