FDA Approves Nicotine Addiction Treatment Pill

TREATMENT July 1997

On May 15 the Food and Drug Administration approved a new nicotine-free anti-smoking drug. The pill, known as Zyban®, is a prescription antidepressant that can help reduce withdrawal symptoms and cravings (Felice J. Freyer, "A pill-a-day smoker," Asbury Park Press, June 3, 1997, p. C1; Lauran Neergaard, "FDA approves a pill to help smokers quit," Philadelphia Inquirer, May 16, 1997, p. A16; Elyse Tanouye, "Glaxo Nonnicotine Pill Is Cleared As Smoking-Cessation Treatment," Wall Street Journal, May 16, 1997, p. B5).

Zyban® works on two brain chemicals, dopamine and norepinephrine, to combat cravings. In clinical trials, 49% of Zyban® users quit smoking after four weeks, compared with 36% who used a nicotine patch and 23% who used a placebo. Zyban® can be combined with the patch, and 58% of users who tried that approach quit. In another study, 25% of Zyban® users who used it for a month were still cigarette-free after a year, nonusers had half that success rate.

Zyban® is manufactured by Glaxo Wellcome Inc., and is actually better known as the antidepressant Wellbutrin-SR®. It has been renamed to distinguish its new use, and ought to be on pharmacy shelves by the middle of July.

"We've demonstrated that you can treat smoking addiction with a non-nicotine approach. I would call it a breakthrough," said Andrew Johnston, a pharmacologist who works with Glaxo Wellcome.