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J.Health Sci., 52(4), 443--449, 2006
Development of Triptans in Japan: Bridging Strategy Based on the ICH-E5 Guideline
Rumiko Shimazawa,*, a Yuki Ando,b
Shinji Hidaka,c Kazuyuki Saito,d
Satoshi Toyoshima,b and Fumiaki Kobayashie
aFaculty of Pharmaceutical Science, Doshisha Women's College of Liberal Arts, Kodo, Kyotanabe-shi, Kyoto 610-0395, Japan,
bPharmaceuticals and Medical Devices Agency (PMDA), Shin-Kasumigaseki Bldg., 3-3-2 Kasumigaski, Chiyoda-ku, Tokyo 100-0013, Japan,
cFaculty of Pharmaceutical Sciences at Kagawa Campus, Tokushima Bunri University, 1314-1 Shido, Sanuki-shi, Kagawa 769-2193, Japan,
dFaculty of Pharmaceutical Science, Hokuriku University, Ho-3, Kanagawa-cho, Kanazawa-shi, Ishikawa 920-1181, Japan, and
eCenter for Clinical Trials, Japan Medical Association, Bunkyo Green Court Center Office, 2-28-8 Honkomagome, Bunkyo-ku, Tokyo 113-0021, Japan
In Japan, five new drug applications (NDAs) of triptans have been approved through a bridging strategy. They constituted the largest target disease field among 26 NDAs which had been approved through the strategy between 1999 and 2003. The bridging strategies of the drugs were classified into two major categories to be described below. One was to conduct a placebo-controlled dose-response study as a bridging study in an attempt to extrapolate the data from the pivotal foreign Phase III studies including a repeated dose study (i.e., zolmitriptan, sumatriptan succinate, and eletriptan hydrobromide). Another was to conduct a placebo-controlled Phase III study in Japan in an attempt to extrapolate the data for efficacy from a repeated dose study (i.e., sumatriptan and rizatriptan benzoate). The extrinsic ethnic factors relating to triptans did not interfere with the extrapolation of foreign clinical data in the five applications. A bridging strategy reduced the number of clinical trials and/or sample size. The accumulation of these bridging experiences indicated that foreign clinical data could be used to support the approval of triptans in Japan.
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