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Global Ambitions For A Bulgarian Pill To Help Smokers Quit

For decades, smokers behind the iron curtain had special help when it came to quitting smoking. A pill derived from the seeds of the Golden Rain acacia tree helped lessen cravings for nicotine.

A Bulgarian pharmaceutical company has sold the drug in Eastern Europe as under the brand name Tabex since the 1960s. In Poland, where it remains popular, a course of treatment costs about $15. It's not approved for use in the U.S.

But the medicine is getting another look as an inexpensive way to aid smoking cessation. The active ingredient, cytisine, may be be particularly appealing in developing countries where smoking rates are high and alternative therapies, such as nicotine gum and patches, cost a lot.

Tabex beat a placebo in helping people refrain from cigarettes up to a year after they stopped taking the drug, according to results in the latest New England Journal of Medicine

The study, conducted in Poland, found that 8.4 percent of people who took the drug hadn't smoked for 12 months compared with 2.4 percent for those who got a dummy pill.

Those results show the pill isn't exactly magic, when it comes to helping people quit. Studies of Chantix, a Pfizer pill that works in much the same way, showed higher abstinence rates — around 20 percent — at one year after starting a three-month treatment.

Psychiatric side effects, including suicidal thoughts and hostility, have been reported with Chantix, which now carries a stern safety warning.

In the study of Tabex, the most common side effects were such things as nausea and stomachache. Psychiatric events were reported more in about 4.6 percent of people taking the drug versus about 3.2 percent of those on placebo, a difference that wasn't meaningful.

But the study, as the authors point out, wasn't large enough (only 740 people) to detect uncommon side effects. The research was funded by the United Kingdom National Prevention Research Institute.

Bloomberg News reports Extab Corp. has licensed global rights to Tabex and is conducting clinical test to meet the standards of Western regulators.

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