Pfizer says its anti-smoking medication is more effective than current treatment

New York, Nov. 15 - Pfizer Inc. said that its smoking cessation medicine varenicline tartrate is more effective than the only marketed oral prescription anti-smoking medicine, according to data presented to the annual meeting of the American Heart Association.

In two double-blind placebo-controlled studies involving about 2,000 smokers, patients received either varenicline (1 mg twice daily), bupropion, marketed as Zyban (150 mg twice daily), or placebo for 12 weeks. Patients were followed for an additional 40 weeks without treatment.

In both studies, 44% of patients taking varenicline quit by the end of the 12-week treatment period, significantly more than the 30% of Zyban patients who quit. Among patients receiving the placebo, 18% had quit by the end of the 12-week treatment period.

The odds of quitting smoking for patients taking varenicline were approximately two times higher than those on bupropion, and four times higher than those on placebo, Pfizer said.

After one year, patients who received varenicline were significantly more likely to remain smoke-free compared to patients who received bupropion or placebo.

A third study randomized smokers who successfully quit smoking after 12 weeks of varenicline to 12 weeks of either placebo or an additional 12 weeks of varenicline. These patients were followed for 28 weeks after the treatment.

There were significant benefits observed among patients who received additional treatment after successfully quitting on varenicline. Seventy-one percent of patients who received the additional course of varenicline remained abstinent after six months, compared to 50% who received placebo as the second course.

Varenicline is a selective nicotinic acetylcholine receptor partial agonist, the first in a new class of potential smoking cessation therapies.

"Varenicline was specifically designed to work at the same receptor site as nicotine to relieve craving and withdrawal symptoms while at the same time blocking the reinforcing effects of nicotine," said Salomon Azoulay, varenicline development lead at Pfizer, in a news release.

Pfizer intends to market varenicline under the name Champix once it obtains approval. The New York-based pharmaceutical company submitted a New Drug Application to the Food and Drug Administration and European registration this month.

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