ROANOKE TIMES 
                      Copyright (c) 1996, Roanoke Times

DATE: Saturday, April 20, 1996               TAG: 9604220040
SECTION: NATIONAL/INTERNATIONAL   PAGE: A-1  EDITION: METRO 
DATELINE: SILVER SPRING, MD.
SOURCE: Associated Press

LET SMOKERS BUY PATCH ON OWN, EXPERTS SUGGEST FDA ADVISERS SAY NONPRESCRIPTION USE SAFER THAN SMOKING

Smokers should be able to buy two kinds of nicotine patches to help them kick the habit without a prescription, scientific advisers told the Food and Drug Administration on Friday.

The committee voted unanimously that both Nicotrol and its competitor Nicoderm should be sold over the counter, giving smokers a choice of a one-dose patch to replace their cigarettes' nicotine or a patch that weans them by slowing dropping nicotine dosages.

Nonprescription patches will help ``those who are addicted to nicotine to hopefully break their addiction,'' Dr. Louis Sullivan, former Health and Human Services secretary, told the FDA committee.

The FDA isn't bound by advisory committee decisions but usually follows them. It already has allowed nicotine-dispensing chewing gum to sell over the counter - nonprescription Nicorette hit pharmacy shelves Thursday.

Patch makers plan to warn smokers not to overdose, either by smoking while the patch is still oozing nicotine or by wearing too many patches at once. That might be especially dangerous for smokers with heart disease or certain other health risks, who should consider consulting a doctor, the patch packages will say.

But the FDA's advisers said such a warning is just a precaution, and might even be a barrier to patch sales, because no studies show a real risk from patches.

``I want lots of people to use'' the patches, said committee Chairman Randy Juhl, pharmacy dean at the University of Pittsburgh.

``We always believe someone is better off on the patch than they are smoking,'' agreed Dr. Tony Temple of McNeil Consumer Products, maker of Nicotrol.

Patch makers hope to join Nicorette over the counter by year's end. Studies estimate that three-fourths of the nation's 46 million smokers would like to quit but have failed or fear trying. Manufacturers say 70 percent of would-be quitters don't want to see a doctor first.

The patch resembles a big bandage, worn on the upper arm. Prescription versions release nicotine through the skin in smaller and smaller doses to wean smokers off cigarettes. But to simplify selling, nonprescription Nicotrol will come in only one strength - 15-milligram patches to be used for no longer than six weeks.

Nicoderm will offer 21-milligram, 14-milligram and 7-milligram patches, so smokers can wean themselves over 10 weeks. It should not be used longer than that, because it has not been studied for use beyond that period, maker Hoechst Marion Roussel warned.

In studies, both patches worked about as well as their prescription counterparts.

Typical of anti-smoking plans, relapse was common, but showed little discrepancy between the two groups. One year later, 8.4 percent of prescription Nicotrol users, for example, were smoke-free, vs. 10.2 percent of nonprescription users. Data were similar for Nicoderm.

LENGTH: Medium:   62 lines
ILLUSTRATION: GRAPHIC:  Chart by AP. color.