Inhibits A Sense Of Satisfaction Associated With Smoking And Relieves Tobacco Craving
Pfizer Inc announced today that on May 8, 2008, it will launch
Champix(R) 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. The currently available
smoking cessation aids such as ´Nicotine Replacement Therapy´ (NRT)
relieve withdrawal symptoms associated with smoking cessation by
replacing tobacco use through delivering nicotine. In contrast
Champix brings about a smoking cessation effect through a new
mechanism of action which works by selectively targeting the
alpha4beta2 nicotine receptors in the brain to reduce both craving and
withdrawal symptoms and reduce the pleasure associated with smoking.
Champix reduces withdrawal symptoms and tobacco craving associated
with smoking cessation by acting on the same receptor in the brain as
nicotine (the alpha4beta2 nicotine receptor) but with higher affinity.
Champix partially stimulates the receptor and triggers a reduced
dopamine response, which helps to relieve the craving and withdrawal
symptoms associated with stopping smoking. At the same time, Champix
prevents nicotine from binding at the receptor, so if a smoker slips
and smokes a cigarette, Champix reduces the reward and sense of
pleasure associated with smoking.
"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.
As of April 1, 2006, medical service providers under the Japanese
national health insurance (NHI) system which meet certain registration
criteria are designated as ´smoking cessation treatment facilities´
and can fully reimburse the cost of smoking cessation treatments to
patients with nicotine dependence. In order for a patient to receive
NHI treatment, he or she must meet certain requirements.
"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.
Japan has one of the highest rates of smoking among developed
nations, with approximately 26 million smokers. Although many smokers
want to quit, studies show that withdrawing from nicotine dependence
using willpower alone is very difficult because smoking is a chronic
relapsing medical condition that typically involves a physical and
psychological addiction to nicotine. In light of this information, the
NHI approved coverage for smoking cessation treatments in April 2006
thereby enabling patients to receive treatment for nicotine addiction
by physicians. Approved in more than 60 countries, Champix has been
used by more than 5 million people around the world. The launch of
Champix in Japan will bring another medical option for smoking
cessation treatment, and it will contribute to more effective smoking
cessation treatment for patients with nicotine dependence.
