May 20, 2015Products
Toray Receives Japanese Approval for Additional Indication of Pruritus Treatment REMITCH CAPSULES 2.5 μg and Promotion to Start
Toray Industries, Inc. (head office: Chuo-ku, Tokyo; President: Akihiro Nikkaku; hereinafter referred to as “Toray”) today announced that on May 20, 2015 it received approval for partial change to the manufacturing and marketing approval of REMITCH® CAPSULES 2.5 μg (hereinafter referred to as the “Agent”) to include its new indication for improvement of pruritus in chronic liver disease patients in case of insufficient effectiveness of the treatment using existing drugs (hereinafter referred to as the “New Indication”) in Japan. Toray already has manufacturing and marketing approval for the Agent, which is being promoted and distributed by Torii Pharmaceutical Co., Ltd. (head office: Chuo-ku, Tokyo; President: Shoichiro Takagi; hereinafter referred to as “Torii Pharmaceutical”) as a treatment of pruritus in hemodialysis patients in the country.
Sumitomo Dainippon Pharma Co., Ltd. (head office: Osaka; President: Masayo Tada; hereinafter referred to as “Sumitomo Dainippon Pharma”) will provide drug information regarding the New Indication of the Agent at medical institutions from May 20, 2015 in accordance with the promotion contract signed between Torii Pharmaceutical and Sumitomo Dainippon Pharma.
Toray will continue to supply the Agent to Torii Pharmaceutical, which will distribute it and provide the drug information regarding the treatment of pruritus in hemodialysis patients to medical institutions.
The three companies expect that the approval of the Agent’s New Indication would significantly contribute to the treatment of pruritus in chronic liver disease patients by offering a new treatment option.
The following is the profile of REMITCH® CAPSULES 2.5 μg:
- Brand name: REMITCH® CAPSULES 2.5 μg
- Generic name: nalfurafine hydrochloride
- Indication (the underlined part has been added): Improvement of pruritus in the following patients (in case of insufficient effectiveness of the treatment using existing drugs): hemodialysis patients, chronic liver disease patients
- Dosage and administration: For adults, orally administer 2.5 μg of nalfurafine hydrochloride once a day after supper or before bed. The dosage can be increased depending on the symptoms and the upper limit is 5 μg once a day.
- Date of approval for partial change to the manufacturing and marketing approval: May 20, 2015
- Manufacture and sales by: Toray Industries, Inc.
<REMITCH® CAPSULES 2.5 μg>
The Agent is the world’s first highly selective kappa opioid receptor agonist created by Toray and has been distributed in Japan by Torii Pharmaceutical as a treatment of pruritus in hemodialysis patients since March 2009. It was developed as it controls itching based on a mechanism that is different from antihistamines and anti-allergy drugs and, therefore, is expected to be effective on pruritus which cannot be controlled by existing treatments.
Pruritus experienced by chronic liver disease patients, even if non-inflammatory on the skin, is known to cause severe itching all over the body. Although multiple factors are believed to be affecting the pruritus experienced by such patients, the exact cause is yet to be identified. Existing treatments for itching fail to sufficiently control this pruritus and development of effective treatments have been sought.
- Toray Industries, Inc.
- Head office: 1-1, Nihonbashi-Muromachi 2-chome, Chuo-ku, Tokyo
- President: Akihiro Nikkaku
- Capitalization: 147,873 million yen (as of the end of March, 2015)
- Torii Pharmaceutical Co., Ltd.
- Head office: Torii Nihonbashi Building, 4-1, Nihonbashi-Honcho 3-chome, Chuo-ku, Tokyo
- President: Shoichiro Takagi
- Capitalization: 5,190 million yen (as of the end of March, 2015)
- Sumitomo Dainippon Pharma Co., Ltd.
- Head office: [Osaka] 6-8, Doshomachi 2-chome, Chuo-ku, Osaka, Osaka
- [Tokyo] 13-1, Kyobashi 1-chome, Chuo-ku, Tokyo
- President: Masayo Tada
- Capitalization: 22,400 million yen (as of the end of March, 2015)