Inhibits A Sense Of Satisfaction Associated With Smoking AndRelieves Tobacco Craving
Business Editors/Health/Medical Writers
TOKYO--(BUSINESS WIRE)--April 22, 2008--Pfizer Inc announced todaythat on May 8, 2008, it will launch Champix(R) Tablet 0.5mg/1mg(varenicline tartrate), a novel smoking cessation aid for smokers withnicotine dependence in Japan, which has one of the highest rates ofsmoking among developed nations.
Champix was developed as the first non-nicotine drug designed forsmoking cessation in the United States and will be the first oralsmoking cessation aid available in Japan. The currently availablesmoking cessation aids such as Nicotine Replacement Therapy (NRT)relieve withdrawal symptoms associated with smoking cessation byreplacing tobacco use through delivering nicotine. In contrast,Champix brings about a smoking cessation effect through a newmechanism of action which works by selectively targeting thealpha4beta2 nicotine receptors in the brain to reduce both craving andwithdrawal symptoms and reduce the pleasure associated with smoking.
Champix reduces withdrawal symptoms and tobacco craving associatedwith smoking cessation by acting on the same receptor in the brain asnicotine (the alpha4beta2 nicotine receptor) but with higher affinity.
Champix partially stimulates the receptor and triggers a reduceddopamine response, which helps to relieve the craving and withdrawalsymptoms associated with stopping smoking. At the same time, Champixprevents nicotine from binding at the receptor, so if a smoker slipsand smokes a cigarette, Champix reduces the reward and sense ofpleasure associated with smoking.
"Pfizer is delighted to be able to provide patients and physiciansin Japan with Champix, a breakthrough medicine for smoking cessationthat has helped millions of smokers who want to quit," said JeffKindler, chairman and chief executive officer of Pfizer. "Furthermore,we are gratified that health authorities in Japan recognize thebenefits of therapies such as Champix that address a major unmetmedical need."Champixs approval in Japan was based on a 12-week, randomized,double-blind, placebo-controlled study in Japanese smokers who wantedto quit smoking. The primary endpoint, the percentage of subjects whodid not smoke at all during the four consecutive weeks between Week 9and Week 12 was 65.4 percent (85/130 cases) in the Champix 1mgtwice-daily group and 39.5 percent (51/129 cases) in the placebogroup, a statistically significant difference between the two groups.
The most common side effects of Champix were nausea, headache, andconstipation, but most of them were mild.
As of April 1, 2006, medical service providers under the Japanesenational health insurance (NHI) system which meet certain registrationcriteria are designated as smoking cessation treatment facilities
and can fully reimburse the cost of smoking cessation treatments topatients with nicotine dependence. In order for a patient to receiveNHI treatment, he or she must meet certain requirements.
"Smoking is a chronic, relapsing medical condition and one of theleading causes of preventable disease, death and disability in theworld," said Hiromitsu Iwasaki, president and chief executive officerof Pfizer Japan. "Champix represents a major clinical advance forsmoking cessation which we hope, together with counseling, will helppatients end their addiction to the nicotine in tobacco."With the launch of Champix, Pfizer Japan will introduce a websitefor patients with nicotine dependence called "SUGU KIN-EN (SmokingCessation Now) at www.sugu-kinen.jp" as of May 8, 2008. This websiteprovides easy-to-understand guidance on smoking cessation andtreatment options. The website also offers a list of medicalinstitutions that provide smoking cessation treatment throughoutJapan.
Japan has one of the highest rates of smoking among developednations, with approximately 26 million smokers. Although many smokerswant to quit, studies show that withdrawing from nicotine dependenceusing willpower alone is very difficult because smoking is a chronicrelapsing medical condition that typically involves a physical andpsychological addiction to nicotine. In light of this information, theNHI approved coverage for smoking cessation treatments in April 2006,thereby enabling patients to receive treatment for nicotine addictionby physicians. Approved in more than 60 countries, Champix has beenused by more than 5 million people around the world. The launch ofChampix in Japan will bring another medical option for smokingcessation treatment, and it will contribute to more effective smokingcessation treatment for patients with nicotine dependence.
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CONTACT:
Pfizer Inc
N.Y. Media Contact
Francisco Gebauer, 212-733-5191
or
N.Y. Investor Contact
Suzanne Harnett, 212-733-8009
or
Japan Contact
Setsuko Yamashita, 81-3-5309-6726 |