PFIZER'S ANTI-SMOKING DRUG RECEIVES POSITIVE CHMP OPINION

Pfizer has announced 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 (varenicline), a treatment for smoking cessation. The CHMP's positive recommendation will be reviewed by the European Commission, which has authority to approve medicines for the European Union.

Champix (varenicline) is believed to work by reducing the severity of the smoker's craving and many withdrawal symptoms from nicotine addiction.

The drug received U.S. FDA approval 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.