ROANOKE TIMES
Copyright (c) 1996, Roanoke Times
DATE: Tuesday, March 26, 1996 TAG: 9603260053
SECTION: NATIONAL/INTERNATIONAL PAGE: A-1 EDITION: METRO
SOURCE: Associated Press WASHINGTON
NOTE: Below
Hard-core smokers are about to get new help in kicking the habit: a nasal spray that gives them a shot of nicotine from a bottle instead of a cigarette.
Nicotrol NS is a pump bottle that holds 100 milligrams of pure nicotine that smokers can inhale to ward off cigarette cravings. It is to be sold by prescription only to adult smokers trying to quit, the Food and Drug Administration announced Monday.
But the FDA warned that smokers could become as dependent on the nasal spray's nicotine as they are on cigarettes. Scientists already discovered one desperate woman who plotted ways to get the nasal spray for a year when she ran out of a three-month supply received during a research study.
Smokers should try to use the spray for just three months - and never longer than six months, the FDA said.
Despite the risk, Nicotrol NS ``will be a very big help to smokers in general, but specifically to the heavier smokers,'' said Dr. Richard Hurt, director of the nicotine dependency center at Mayo Clinic.
``It's clearly safer for the patient to use the nicotine nasal spray than cigarettes.''
McNeil Consumer Products of Fort Washington, Pa., will begin selling the spray later this year, but would not reveal an exact date or price.
Smoking cessation is a multimillion-dollar industry. Nicorette gum goes on sale next month without a prescription. Also next month, the makers of two nicotine patches, now sold by prescription to some 3 million would-be quitters, will seek FDA permission to sell over the counter. Some 20 percent to 25 percent of gum and patch users quit smoking.
The nicotine nasal spray, developed by Pharmacia & Upjohn Inc., hits the bloodstream faster than the gum or patch, offering the potential of almost immediate relief of cigarette cravings.
No one has compared Nicotrol NS directly to nicotine gum or patches. But studies of 730 patients found 25 percent given the nasal spray stopped smoking for at least a year, compared with 13 percent of smokers who tried to quit without help.
A squirt up each nostril gives the smoker 1 milligram of nicotine. Smokers aren't supposed to inhale it more than five times a day. Overdosing is dangerous - 40 milligrams of nicotine at once can be lethal.
A milligram dose may seem large, particularly when low-nicotine cigarettes advertise that smokers' blood absorbs a tenth that amount.
But smokers' brains absorb less nicotine from the spray than from cigarettes, Hurt said. The lungs send smoke-borne nicotine straight to the heart, where it is pumped to the brain in five heartbeats. Nicotrol NS is absorbed through the lining of the nose, where it goes into the bloodstream and circulates through the body before reaching the heart and then the brain, Hurt explained.
It's the same reason snorted cocaine is less potent than smoked crack cocaine, he said.
Addiction is a fairly remote risk, largely because the spray's sting can make it unpleasant to use, the FDA acknowledged. Among 369 spray users Pharmacia studied, only 26 used Nicotrol NS for a year, including the woman who plotted to get unused bottles from other study participants and watered them down to make them last.
But Pharmacia must track Nicotrol NS to prove to the FDA that smokers don't abuse it - and that the spray doesn't circulate among teen-agers, who are not supposed to use it.
And the manufacturer must figure out how smokers can wean themselves from the nicotine spray with the least chance of relapsing to smoking.
LENGTH: Medium: 71 linesby CNB