28.07.2006 – 17:05
Pfizer's Champix(R) Receives Positive Opinion From CHMP for the Treatment of Smoking Cessation
New York (ots/PRNewswire)
- More Than 1.2 Million Europeans Die of Smoking-Related Diseases Each Year; An Estimated US$500 Billion in Global Health-Related Costs by 2010
- Medical Expert: 'Helping smokers quit is one of the most important things a physician can do to improve their patients' overall health and reduce the risk of developing serious chronic conditions.'
Pfizer Inc said today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Evaluation Agency issued a positive opinion recommending marketing authorization of Champix(R) (varenicline), a novel pill for the treatment of smoking cessation.
The CHMP's positive recommendation will be reviewed by the European Commission, which has authority to approve medicines for the European Union. Pfizer anticipates a final decision from the Commission in the coming months.
Discovered and developed by Pfizer, Champix is a pill specifically designed as an aid to smoking cessation. Champix is believed to work by reducing the severity of the smoker's craving and many withdrawal symptoms from nicotine. Moreover, if a person smokes a cigarette while receiving treatment, Champix has the potential to diminish the sense of satisfaction associated with smoking.
"Globally, it is expected that half a billion people alive today will die from smoking-related causes," said Dr. Joseph Feczko, Pfizer's chief medical officer. "Champix represents a significant new discovery in the arena of smoking cessation research. Pfizer is pleased that the CHMP has recognized the potential therapeutic benefit of Champix in addressing this serious public health issue."
Smoking, the leading cause of preventable death worldwide, is responsible for five million deaths worldwide each year. In Europe alone, more than 1.2 million people die each year from a smoking related disease. By 2010, the WHO estimates the annual global cost of tobacco-related illness to be approximately US$500 billion.
"When it comes to smoking, preventive medicine is truly the best medicine. Smoking harms nearly every organ in the body and is the cause of many diseases including cardiovascular disease, cancer and respiratory disease," said Dr. Serena Tonstad, Champix clinical trial investigator and head physician, Department of Preventive Cardiology, Ulleval University Hospital, Norway. "Helping smokers quit is one of the most important things a physician can do to improve their patients' overall health and reduce their risk of developing serious chronic conditions."
The medication, varenicline, with tradename Chantix(TM) (varenicline) in the United States, received U.S. Food and Drug Administration approval as an aid to smoking cessation in May 2006. In clinical trials, varenicline was generally well tolerated with overall discontinuation rates similar to placebo. The most frequent side effects included nausea, headache, trouble sleeping and changes in dreaming.
US patients and health care providers can visit www.chantix.com or call +1-877-CHANTIX and register to receive more information about CHANTIX. For prescribing information, please visit www.chantix.com.
DISCLOSURE NOTICE: The information contained in this release is as of July 28, 2006. The Company assumes no obligation to update any forward-looking statements contained in this release as a result of new information or future events or developments.
This release contains forward-looking information about Champix that involves substantial risks and uncertainties. A description of these risks and uncertainties can be found in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2005 and in its reports on Forms 10-Q and 8-K.
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