• E-mail
• Print
• Comment
• Font Size
• Digg
• del.icio.us
• Discuss article

New Drug Could Help Smokers

Posted on: Friday, 12 May 2006, 06:07 CDT

By Glenn Singer, South Florida Sun-Sentinel

May 12--Smokers who want to kick the habit will have a new drug to help them starting later this year.

Pfizer Inc. received Food and Drug Administration approval Thursday for Chantix, a prescription medication intended to reduce nicotine cravings in millions trying to stop smoking. The price has not been disclosed.

About one in five people smoke, and "any new drug that holds promise for aiding smoking cessation is something we look forward to with great excitement," said Norman Edelman, chief medical officer for the American Lung Association.

Chantix latches on to the same receptors in the brain to which nicotine binds when inhaled in cigarette smoke, an action that leads to the release of dopamine in the pleasure centers of the brain. Taking the drug blocks any inhaled nicotine from enforcing that effect.

Studies in Europe on about 2,000 smokers showed that a year after initial treatment with Chantix, abstinence rates were 22 percent compared with 16 percent among those given Zyban, a rebranded version of the antidepressant Wellbutrin. Only 8 percent of those given placebos, or sugar pills, had stopped after a year.

Patients will be instructed to take 0.5 milligram once a day for the first three days and then twice a day through the end of the first week of treatment, followed by 1 mg. twice a day from days eight through the end of treatment, usually at 12 weeks.

The pill will compete with Zyban and various gums, patches and lozenges to help smokers quit. It also might compete one day with an anti-smoking therapy being developed by Boca Raton-based Nabi Biopharmaceuticals, whose NicVAX vaccine is a few years away from possible approval.

Executives and scientists at Nabi were encouraged Thursday by Chantix's approval, largely because it indicated the FDA "recognizes the need for new and better antismoking treatments," said Dr. Henrik Rasmussen, Nabi's senior vice president for clinical, medical and regulatory affairs.

In two relatively small clinical trials, financed by the National Institute on Drug Abuse, 40 percent of smokers who received NicVAX injections were still abstaining after six months compared with 9 percent who were given placebos, Rasmussen said. That was without the psychological support that patients in the Chantix studies received, he said.

Analysts say NicVAX could be a superior product because it prevents nicotine from reaching the brain as opposed to altering the brain's reaction to nicotine. Side effects are minimal compared to Chantix, which Pfizer reported can produce nausea, headache, vomiting, gas, insomnia, abnormal dreams and a change in taste perception.

Nabi plans to conduct another large "Phase 2" trial, also financed by the government, and, if all goes well, conduct a larger Phase 3 trial in the second half of 2007. If results remain strong, the company would then seek approval from the FDA, where NicVAX already has been placed on a fast track for accelerated review.

This report was supplemented by Sun-Sentinel wire services.

Glenn Singer can be reached at gsinger@sun-sentinel.com or 561-243-6612.

-----

Copyright (c) 2006, South Florida Sun-Sentinel

Distributed by Knight Ridder/Tribune Business News.

For information on republishing this content, contact us at (800) 661-2511 (U.S.), (213) 237-4914 (worldwide), fax (213) 237-6515, or e-mail reprints@krtinfo.com.

NYSE:PFE, NASDAQ-NMS:NABI,

Source: South Florida Sun-Sentinel

More News in this Category