NEW YORK (Reuters) -- The first non-nicotine-based drug aimed at helping smokers kick the habit has been recommended for approval by a Food and Drug Administration (FDA) advisory committee.
Bupropion hydrochloride, currently marketed as the antidepressant Wellbutrin by Glaxo Wellcome, was found in clinical trials to be an effective agent in smoking cessation therapy.
"When it becomes available, bupropion sustained release in combination with a patient support program will offer smokers a new and different approach to treating their nicotine addiction," said Dr. Richard Hurt, medical director of the Mayo Clinic's Nicotine Dependence Center in Rochester, Minnesota.
Advisory committee recommendations are usually key considerations in the FDA drug approval process.
After one California researcher accidentally discovered that bupropion helped in the effort to quit smoking, Glaxo Wellcome began its own research in a series of seven clinical trials. One seven-week trial of almost 900 smokers found that 49% of those using bupropion remained abstinent, compared with 36% using the nicotine patch. When both bupropion and the patch were used simultaneously, the quit-success rate at 11 weeks was 58%.
The committee expressed concerns about the possibility of seizures, which occur in about 1 in 1,000 patients using bupropion for depression. No seizures were reported in any of the nearly 1,700 patients in the anti-smoking trials.
Because the drug will be sold with a different target population and dosage, Glaxo Wellcome proposes to market it under a new name. The advisory committee was divided on this issue, however, worrying that patients might inadvertently be taking bupropion for both depression and smoking cessation, thus doubling their dose and upping the risk of seizures.
In response, Glaxo Wellcome plans to include clear warnings on the drug's package to eliminate the possibility of double-dosing.
The drug's mechanism of action remains unclear. Bupropion appears to suppress the desire to light up, even making cigarettes taste bad to some smokers. Researchers surmise the drug may interact with chemicals in the central nervous system to short-circuit addiction 'pathways'.
The FDA committee recommends that patients receive thorough instruction and guidance should the drug become part of any anti-smoking program. Glaxo Wellcome says it plans to implement educational efforts, including a toll-free patient advice number and a voluntary counseling program.
Less than 10% of the 15 million U.S. smokers who try to quit each year are successful, according to Dr. Andrew Johnston, head of Psychiatry Clinical Research at Glaxo Wellcome. "It's clear we need a new approach, and bupropion sustained release tablets offer a promising new therapy," Johnston said.
