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Someday, Nicotine Patches and Gum May Be Available Over the Counter With PM-Smoking-Drugs,

November 18, 1994

Someday, Nicotine Patches and Gum May Be Available Over the Counter With PM-Smoking-Drugs, Bjt Graphic NICOTINE FIX

Undated (AP) _ The date: 1997.

The place: Any newsstand.

Customer: ″Yeah, gimme a Times, a TV Guide, and a pack of Marlb ... Wait, make it a pack of those nicotine patches.″

Clerk: ″Gettin’ off the butts, eh? Good luck 3/8″

Smokers hoping to kick the habit can’t have that conversation, but some day it could become common.

Nicotine patches and gum, the only drugs available to help people quit smoking, are available with a prescription, but drugmakers are hoping to gain approval from the Food and Drug Administration to sell them over the counter.

One company says it will file an application for its gum this year. If it succeeds, a patch application is likely later.

The patch resembles a big bandage, worn on the upper arm. It releases nicotine through the skin in smaller and smaller doses to wean smokers off cigarettes.

Wall Street analysts say the gum and the patch are a natural for non- prescription sales. Smokers who don’t want the hassle and cost of a doctor’s visit might try them if they can simply grab them off the shelf.

″Oh, yes, definitely,″ said smoker Jacquelyn Elmers, a graphic designer in Farmington Hills, Mich., when asked during Thursday’s annual Great American Smokeout if she’d try the patches if they became available over the counter. ″They would be more readily available to people who don’t go to the doctor occasionally like they should but are concerned about their health.″

Whether the FDA will agree to over-the-counter sales is in doubt.

Doctors and Wall Street analysts say if such applications are to win approval, the companies must assure the FDA that large numbers of people won’t overdose on the product if they use it without a doctor’s supervision.

Also, the companies must show that the support programs they already offer smokers work.

In many cases, the gum and the patch already include a pamphlet or a toll- free number that a user can consult to receive literature, cassette tapes or information by phone on how to kick the habit.

But smoking cessation experts say the products aren’t much good without the personal attention a doctor can give. Smokers must be taught, for instance, that they don’t need cigarettes to relieve stress, control weight or make them feel more comfortable in social situations.

Even with a prescription, the success rate of the patches is only 20 percent. Smoking cessation specialists say that’s pretty good, considering how hard it is to quit, but well below many smoker expectations - especially after they’ve paid $250 for a 10-week program.

Also, the side effects can be maddening. Some patch users report nightmares or skin rashes. Gum chewers say it tastes terrible.

There are also potential dangers. People must stop smoking while wearing the patch, or they could have heart problems from nicotine overdoses.

″Nicotine is one of the most potent pharmacological agents we have and obviously it’s addictive,″ said Dr. Roger Bone, a lung specialist and president of the Medical College of Ohio in Toledo. ″The issue is people will get a double hit of it if they continue smoking.″

The gum, on the market since the mid-1980s, is the less popular of the two products. The patches, introduced in late 1991, were wildly successful for six months, but the market has since crashed by two-thirds to about 3 million prescriptions this year, mostly because of the low success rate and side effects.

Marion Merrell Dow Inc. of Kansas City is the most aggressive promoter of the products. It’s the only one that makes a gum, Nicorette, which it hopes to begin selling over the counter within a couple of years.

Marion also is conducting human tests of a more potent version of its Nicoderm patch, now the biggest seller. Nicoderm HP will be the new prescription product if regular Nicoderm goes over the counter.

″It’s a big moral question of whether or not people should have access to it without the controls and guidance from a doctor,″ said Kenneth Nover with A.G. Edwards & Sons Inc., a St. Louis investment firm.

All the patch makers already provide tips on exercise, deep breathing, healthy eating and dealing with the cigarette temptation.

But Don R. Powell, who runs the American Institute for Preventative Medicine, a health-care consulting firm, said these haven’t been very useful.

″The literature in and of itself is not enough to get somebody to quit smoking. You have to get them involved, motivated,″ he said.

Marion is trying to do that. This March it began telephoning enrollees to buck them up during the patch program. It also mails them postcards, newsletters and calenders with encouraging tidbits (″Your teeth and fingernails are slowly returning to their normal color.″)

DS-11-17-94 2354EST

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