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January 21, 2009
| Toray Industries, Inc. |
| Japan Tobacco Inc. |
| Torii Pharmaceutical Co., Ltd. |
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Manufacturing and marketing approval
for REMITCH® CAPSULES 2.5 µg , oral antipruritus drug, in Japan |
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Toray Industries, Inc. (Head Office: Chuo-ku, Tokyo; President: Sadayuki Sakakibara; "Toray"); Japan Tobacco Inc. (Head Office: Minato-ku, Tokyo; President: Hiroshi Kimura); and Torii Pharmaceutical Co., Ltd. (Head Office: Chuo-ku, Tokyo; President: Norihiko Matsuo; "Torii" hereby announce that REMITCH® CAPSULES 2.5 µg (generic name: nalfurafine hydrochloride), an oral antipruritus drug that was jointly developed by the three companies and filed for New Drug Application by Toray, has obtained manufacturing and marketing approval for the indication of "improvement of pruritus in hemodialysis patients (only for cases resistant to conventional treatments)" on January 21, 2009.
Marketing of this drug will be initiated by Torii and the timing of launch will be announced following National Health Insurance price listing.
Hemodialysis-related uremic pruritus is a condition that causes systemic and severe itching without inflammation on the skin and its cause has yet been clearly elucidated. It is known that this type of itching is not relieved by conventional antipruritus drugs (such as antihistamines) and the development of effective medicines has long been awaited.
REMITCH® CAPSULES 2.5 µg is a selective κ(kappa) opioid receptor agonist, originated from Toray, Japan that has granted manufacturing and marketing approval for the first time as an oral drug to treat itching in hemodialysis patients that is resistant to existing treatments.
This newly-approved drug is expected to make further contribution to the treatment of pruritus in hemodialysis patients.
Following is the outlines of REMITCH® CAPSULES 2.5 µg.
Notes:
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Brand name: |
REMITCH® CAPSULES 2.5 µg |
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Generic name: |
Nalfurafine hydrochloride |
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Indication: |
Improvement of pruritus in hemodialysis patients
(only for cases resistant to conventional treatments) |
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Dosage and administration: |
The usual oral dosage for adults is 2.5 µg of nalfurafine hydrochloride, once a day, after supper or before sleep. The dosage may be adjusted according to symptoms provided that it does not exceed 5 µg once a day. |
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Date of manufacturing and marketing approval: |
January 21, 2009 |
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Approved manufacturer: |
Toray Industries, Inc. |
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| Corporate Profiles |
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| Toray Industries, Inc. |
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Headquarters: |
1-1, Nihonbashi-Muromachi 2-chome, Chuo-ku, Tokyo |
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President, CEO & COO, representative director: |
Sadayuki Sakakibara |
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Capital: |
96.937 billion yen (as of March 31, 2008) |
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| Japan Tobacco Inc. |
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Headquarters: |
2-1, Toranomon 2-chome, Minato-ku, Tokyo |
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President: |
Hiroshi Kimura |
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Capital: |
100 billion yen (as of March 31, 2008) |
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| Torii Pharmaceutical Co., Ltd. |
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Headquarters: |
Torii Nihonbashi Bldg., 4-1, Nihonbashi-Honcho 3-chome, Chuo-ku, Tokyo |
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President: |
Norihiko Matsuo |
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Capital: |
5.19 billion yen (as of March 31, 2008) |
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