Pfizer’s Champix Approved In Japan

TOKYO - Pfizer is hoping to launch its smoking cessation aid Champix (varenicline) in Japan in April after receiving manufacturing and marketing approval from the Ministry of Health Labor and Welfare Jan. 25, Pfizer Japan told PharmAsia News.

Champix is the first non-nicotine oral smoking cessation treatment approved in Japan, according to the company. Prior to sale, varenicline must still be listed on Japan's National Health Insurance drug reimbursement price list; Pfizer Japan declined to comment on its pricing expectations or on timing for the listing.

The Japanese application was supported by a 12-week, randomized, double-blind, placebo-controlled study in Japanese smokers in which the primary endpoint (the four consecutive-week smoking cessation rate between week nine and week 12) was 65.4 percent (85/130 cases) in patients receiving 1 mg Champix twice-daily, and 39.5 percent in the placebo group (51/129 cases), respectively.

The Japanese label will include stronger warnings related to depression and suicidal thought that were added earlier this month to varenicline's U.S. label, according to the company. "Pfizer Japan and [MHLW] have already discussed these symptoms prior to the approval. These symptoms are to be reflected on the upcoming formal Japanese Champix label," the company told PharmAsia News.

U.S. labeling was revised Jan. 18 to include a neuropsychiatric warning after patients taking the drug experienced suicidal thoughts and erratic behavior. Updated U.S. labeling recommends that patients taking varenicline - known as Chantix in the U.S. - be monitored for symptoms, including changes in behavior, agitation, depressed mood, suicidal ideation and suicidal behavior.

Pfizer Japan plans to roll out an educational campaign related to smoking cessation in conjunction with Champix's launch. "As nicotine dependence is a debilitating disease, awareness programs addressing this will be implemented," the company said. "Furthermore, programs to educate co-medicals on the proper treatment of smoking cessation, as well as the Champix product profile education, will also be implemented."

Varenicline is approved in more than 60 countries, including the U.S. and European Union. The Japanese application was filed in June 2006.

Pfizer Japan said recently it planned to ban on-the-job smoking for its 5,000 employees ahead of Chantix's launch (PharmAsia News, Jan. 3, 2008).

- Joshua Berlin ([email protected])