Study: Generic Quit-Smoking Drug Works

Tabex Used in Russia for More Than 40 Years

From the WebMD Archives

Sept. 28, 2011 -- An inexpensive drug widely used in Central and Eastern Europe, but not approved in the United States, more than tripled smokers’ chances of successfully kicking the habit in a new study published in the latest New England Journal of Medicine.

The drug, Tabex (cytisine), has been used for smoking cessation in Russia and other Eastern European countries for more than four decades, but no rigorous studies have ever been done to prove its effectiveness.

Like the best-selling drug Chantix, marketed by Pfizer, it works by targeting a key nicotine receptor closely tied to tobacco cravings.

But the drug is much cheaper than Chantix and other smoking-cessation treatments, including nicotine replacement gums, patches, and inhalers, says researcher Robert West, PhD, of the University College London.

“In Russia, a (one-month) course of Tabex sells for about $6,” West tells WebMD. “This drug costs less than cigarettes, so it could potentially save a lot of lives in poorer countries where treatments to help people stop smoking have generally not been widely available.”

Tobacco Cessation Treatments Costly

Cigarette smoking contributes to an estimated 5 million premature deaths each year across the globe. Of the more than 1 billion smokers on the planet, about two-thirds live in countries where the average income is less than $200 per week and where tobacco cessation treatments are far more costly than buying cigarettes, West says.

According to West, in China a two-month course of nicotine-replacement gum costs the equivalent of about $230 while 20 cigarettes can cost as little as 15 cents.

West says he became interested in studying Tabex after learning of the drug from Polish epidemiologist Witold Zatonski, MD, of the Cancer Center and Institute of Oncology in Warsaw.

“He had been going to conferences for several years telling anyone who would listen that this drug worked,” West says. “He showed me some data from his clinic that looked quite promising.”

The new study, which Zatonski co-authored, included 740 smokers randomly assigned to treatment with either Tabex or placebo for 25 days. Neither the smokers nor the researchers knew which therapy was being given.

Continued

A year later, 8.4% of the study participants taking Tabex had successfully given up cigarettes compared to 2.4% of the participants taking the placebo.

West says a major strength of the study was that it was publicly funded through a grant from the U.K.’s Medical Research Council.

Study participants got very little behavioral support because the researchers wanted to mimic the lack of supportive medical care in low-resource regions of the world where smoking rates are highest.

“For the most part, these people were on their own, so the findings tell us that this drug can work in countries without a lot of medical resources,” West tells WebMD.

Tabex in U.S.? More Study Needed

West says Tabex could also benefit smokers who want to quit in the U.S. if approved by the FDA. He adds that the agency will probably require more studies of the drug before taking any action.

Tabex was developed and is marketed by the Bulgarian pharmaceutical company Sopharma, and it has been licensed to Maryland-based Extab Corp. According to Extab’s web site, the company’s sole purpose is to obtain approval for the drug in the U.S. and other countries where it is not yet available.

Smoking cessation expert Michael C. Fiore, MD, agrees that more study is needed before the drug is approved in the U.S.

Fiore directs the University of Wisconsin Center for Tobacco Research and Intervention in Madison.

“This is a promising first study that needs to be replicated,” he tells WebMD. “A very low-cost generic drug that is both safe and effective would be a very helpful addition to smoking cessation efforts in the United States.”

Fiore says smokers who want to quit have the best chance of succeeding when they combine medication with counseling.

Telephone counseling to help smokers quit is available for free for U.S. residents at 800-QUIT-NOW.

WebMD Health News Reviewed by Laura J. Martin, MD on September 28, 2011

Sources

SOURCES:

West, R., New England Journal of Medicine, Sept. 29, 2011.

Robert West, PhD, University College London.

Michael C. Fiore, MD, MPH, director, University of Wisconsin Center for Tobacco Research and Intervention, Madison; professor of medicine, University of Wisconsin Medical School.

News release, Medical Research Council.

Extab Corp. web site: “Our Company.”

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