Pharmaprojects R&D Pipeline News Feed
Champix receives Japanese marketing authorization
31 Jan 2008
Champix (varenicline tartrate) has been approved for marketing in Japan, following the results of a Japanese clinical trial in which almost twice as many smokers quit for the last 4 consecutive weeks of a 12 week trial as those on placebo. This approval follows the US launch in August 2006, EU approval in September 2006 and Canadian launch in May 2007. To date, more than 5 million people globally have used Champix.
Champix is an oral smoking cessation aid, developed by Pfizer to assist smokers overcome nicotine dependency. It is a non-nicotine partial agonist for a4ß2 nicotine receptors. It relieves withdrawal and craving symptoms via agonist properties, while acting as an antagonist to block the receptors if nicotine is introduced, thereby reducing the pleasurable effects associated with smoking tobacco products.
The causal link between lung cancer and tobacco smoking was established more than 50 years ago, and now tobacco consumption is the single biggest cause of preventable illness and early death in the UK and the US. Each year more than 400,000 Americans die from cigarette smoking, with one in every five deaths being smoking related, while in the UK, smoking-related deaths exceed 114,000 people per year. Overall tobacco smoking is estimated to be responsible for approximately 30% of cancer deaths in developed countries, and it is thought that one in two regular cigarette smokers will eventually be killed by their tobacco habit, half of these in middle age.
Champix is the first oral smoking cessation aid to be made available in Japan, where the smoking rate is almost 50% amongst men. Japanese cancer rates have spiralled from 4.3% in 1935 to 30.1% in 2005, and until now, the current method of assistance for smokers has been nicotine replacement therapies.
