Feds and smokers fume over the right to inhale

0 Comments | Insight on the News, April 24, 1995 | by Hank Cox, | Valerie Richardson

That's what makes his latest experiment so remarkable. The laboratory is conducting clinical trials on a new antismoking product with a startling difference: no nicotine. Called NicErase, its active ingredient is lobeline, an extract of the lobelia flower. If it works - and wins approval by the Food and Drug Administration - researchers say it could revolutionize the antismoking industry. "Nothing has been approved that doesn't contain nicotine," says Glover. "If someone can come up with a non- nicotine product, it has great potential."

The product is being tested at three universities - West Virginia, the University of Arizona and the University of Nebraska. About 180 subjects are involved in "double-blind placebo controls," which means that half the students receive NicErase and half receive placebos, but researchers don't know who's getting what until the trials are over.

Glover expects the four-month trials to conclude in April, after which the product will go before the FDA for approval. If all goes well, NicErase could be on the market in less than two years, says Jay Wadekar, chairman of DynaGen Inc., which developed the product.

Its potential recently captured the attention of pharmaceutical giant Bristol-Myers, which signed an agreement with DynaGen last month for the first option to exclusive U.S. rights to manufacture NicErase. In March, the company was awarded patents for two of its lobeline-based treatment programs.

Whether the product really helps people quit smoking remains to be seen. Several lobeline-based kick-the-habit products sat on drugstore counters for years without fanfare before the FDA withdrew all antismoking products from the market in 1993 and began demanding clinical trials. DynaGen officials say the main difference between those products and NicErase lies in how the drug is administered.

"Lobeline is not effective if taken as a pill and swallowed. It has to enter the bloodstream," says DynaGen spokesman Jack Barlow. "At first we were injecting it. Then we tried administering it under the tongue, and it worked."

It certainly worked for Ron Benak, a 51-year-old real-estate appraiser who participated in a pilot trial last year at Lee Research Center in Fort Myers, Fla. Benak was a pack-and-a-half-a- day smoker for 35 years, then he tried NicErase. "I haven't had a cigarette since the first day, and that was in June," he says.