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Wednesday, 27 June 2012

Japan introduction of PAXIL / Seroxat 1999 - linked to documented reduction of suicide - goodnews FIDDAMAN CASPER?

extract -

The number of suicides in Japan each year -- which hit a peak of 33,048 in 1999 -- declined 3.3% in 2000 and another 2.9% in 2001, the first full two years that SSRIs were available. However, the rate remains very high compared with earlier years, and many factors can contribute to suicide, so it's too early to tell whether the new drugs contributed to the reduction.

A newspaper ad by Japanese drug maker Shionogi & Co. promoting awareness of depression. It shows actress Nana Kinomi urging people to talk about the disease.

Japanese sales of GlaxoSmithKline's Paxil reached ¥12 billion ($96.5 million) in 2001, its first full year on the market, and the figure is on track to rise this year. By comparison, U.S. sales of the drug last year were $1.8 billion. Japanese sales of Luvox and Depromel -- the name under which the drug is sold by Meiji's marketing partner, Fujisawa -- totaled ¥14.5 billion last year. (In May Solvay removed Luvox from the U.S. market, where it had been approved to treat obsessive-compulsive disorder, after the Food and Drug Administration cited problems with documents filed by Solvay to the FDA. The company, which has been the drug's U.S. marketer, says Luvox is safe and expects it to be back on the market next year. The generic form of the drug, fluvoxamine, is still sold in the U.S.)

Other drug companies have also ramped up their efforts in Japan. Pfizer Inc. had started trials of its blockbuster Zoloft in Japan in the early '90s, but its crucial large-scale human trial failed to use strict enough standards when picking patients, says Kenneth Wolski, who oversaw the trial as head of development for Pfizer's Japan subsidiary until he left the company in 1996. The company's new-drug application, which has been pending with Japanese regulators since 1998, hasn't been approved. A Pfizer spokesman blamed the low awareness of depression in Japan at the time, and "different standards in clinical-trial design." Two months ago, Pfizer announced a new clinical trial of Zoloft at 20 sites across Japan.

And Prozac -- which had world-wide sales of $1.99 billion and U.S. sales of $1.53 billion last year -- is finally coming to Japan. Andrew Macarenas, head of Lilly's Japan operations, says it should be on the market by 2004 -- some 17 years after it first went on sale in the U.S. The company is preparing the way by paying for the activities of a committee of Japanese doctors that promotes awareness of depression. The committee holds seminars for doctors and operates a Web site. "A number of things are happening to take mental health out of the cupboard" in Japan, says Mr. Macarenas. "It's not a taboo anymore."

The message from drug companies has fit well with Japan's medical culture. Japanese doctors are accustomed to loading up patients with medication, and are permitted to sell drugs directly to patients, often at a significant profit. Meiji and Glaxo have conducted hundreds of seminars about depression for general practitioners and psychiatrists across Japan, and the companies say interest is strong.

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