FDA Approves First Nicotine-Free Drug to Help Smokers

WASHINGTON — Glaxo Wellcome on Thursday won Food and Drug Administration approval to market its anti-depression drug Zyban as the first nicotine-free prescription pill to help smokers kick the habit.

The approval gives Glaxo access to the $500-million U.S. smoking-cessation market, currently dominated by nicotine patches and gum from SmithKline Beecham and Johnson & Johnson. Zyban and a nicotine inhaler from Pharmacia & Upjohn are expected to help boost the market to $1 billion annually in the next few years, analysts said.

Zyban, sold for seven years in the United States under the name Wellbutrin to treat depression, helps reduce a smoker’s craving for cigarettes and lessens withdrawal symptoms. It’s not clear exactly how the drug works, although it affects mechanisms in the brain linked to nicotine addiction.

With the approval for smoking cessation, Zyban could eventually generate as much as $490 million in annual sales, said analysts at ABN Amro Hoare Govett. That’s good news for Glaxo, which expects to lose patent protection for its best-selling ulcer drug Zantac as early as this summer.

“On their sales base, it’s not that important, but it does demonstrate that the company is filling in the gaps when Zantac loses its patent,” ABN Amro analyst Mark Brewer said.

Glaxo is the world’s second-largest drug maker, with annual sales of $13.5 billion, after Switzerland’s Novartis.

London-based Glaxo’s American depositary receipts rose 87.5 cents to close at a record high of $42.25 in New York Stock Exchange trading.

New awareness of the dangers of smoking is driving growth in products like SmithKline Beecham’s chewing gum Nicorette and nicotine patch Nicoderm, which were approved for nonprescription use in the United States last year. The two products, which help wean smokers by delivering small amounts of nicotine to the bloodstream, generated $345 million in U.S. sales, SmithKline said.

London-based SmithKline said has it captured 87% of the market for smoking-cessation products in the United States. Unlike Zyban, Nicorette and Nicoderm contain nicotine, the addictive ingredient in tobacco.

In clinical trials, Zyban was more effective than nicotine patches in helping smokers quit, while a combination of the patch and Zyban produced the best results, the company reported. In a four-week study, 58% of volunteers using Zyban and a patch hadn’t resumed smoking, compared with 49% for Zyban alone, 36% for the patch alone and 23% for those getting a placebo.

Researcher Dr. David Sachs of the Palo Alto Center for Pulmonary Disease Prevention called the pills “the most important medical advance” in the stop-smoking field since 1984. About 16 million Americans try to quit smoking each year--and about 14 million of them fail.

Company executives said the drug will be available in six to eight weeks at a price yet to be determined, and will include a support program.