Japan: Pfizer To Launch Champix(R) The First Prescription Oral Smoking Cessation Aid In The Country

Main Category: Smoking / Quit Smoking
Article Date: 23 Apr 2008 - 4:00 PDT

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Pfizer Inc announced that on May 8, 2008, it will launch Champix® Tablet 0.5mg/1mg (varenicline tartrate), a novel smoking cessation aid for smokers with nicotine dependence in Japan, which has one of the highest rates of smoking among developed nations.

Champix was developed as the first non-nicotine drug designed for smoking cessation in the United States and will be the first oral smoking cessation aid available in Japan.

"Pfizer is delighted to be able to provide patients and physicians in Japan with Champix, a breakthrough medicine for smoking cessation that has helped millions of smokers who want to quit," said Jeff Kindler, chairman and chief executive officer of Pfizer. "Furthermore, we are gratified that health authorities in Japan recognize the benefits of therapies such as Champix that address a major unmet medical need."

Champix's approval in Japan was based on a 12-week, randomized, double-blind, placebo-controlled study in Japanese smokers who wanted to quit smoking. The primary endpoint, the percentage of subjects who did not smoke at all during the four consecutive weeks between Week 9 and Week 12 was 65.4 percent (85/130 cases) in the Champix 1mg twice-daily group and 39.5 percent (51/129 cases) in the placebo group, a statistically significant difference between the two groups. The most common side effects of Champix were nausea, headache, and constipation, but most of them were mild.

"Smoking is a chronic, relapsing medical condition and one of the leading causes of preventable disease, death and disability in the world," said Hiromitsu Iwasaki, president and chief executive officer of Pfizer Japan. "Champix represents a major clinical advance for smoking cessation which we hope, together with counseling, will help patients end their addiction to the nicotine in tobacco."

With the launch of Champix, Pfizer Japan will introduce a website for patients with nicotine dependence called "SUGU KIN-EN (Smoking Cessation Now) at www.sugu-kinen.jp" as of May 8, 2008. This website provides easy-to-understand guidance on smoking cessation and treatment options. The website also offers a list of medical institutions that provide smoking cessation treatment throughout Japan.

Pfizer Japan