For Immediate Release
Company name: DAIICHI SANKYO COMPANY, LIMITED
Representative: Sunao Manabe, Representative Director, President and COO
(Code no.: 4568, First Section, Tokyo Stock Exchange)
Please address inquiries to Noriaki Ishida, Executive Officer,
Vice President, Corporate Communications Department
Telephone: +81-3-6225-1126
http://www.daiichisankyo.com
Daiichi Sankyo Announces Launch of Narurapid® Tablets and Narusus® Tablets for Cancer Pain Treatment
Tokyo, Japan (June 19, 2017) – Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that it has launched Narurapid® Tablets 1 mg, 2 mg, 4 mg (immediate release formulation) and Narusus® Tablets 2 mg, 6 mg, 12 mg, 24 mg (once daily extended release formulation) for cancer pain treatment (generic name: hydromorphone hydrochloride).
Hydromorphone hydrochloride is an opiate, narcotic analgesic that has been available outside of Japan for over 80 years, and is the standard drug for the treatment of cancer pain according to WHO guidelines.
Hydromorphone hydrochloride is one of the agents publicly offered for development by the Review Committee on Unapproved Drugs and Indications with High Medical Needs*. Daiichi Sankyo decided to develop the drug in 2012, and received a grant from the Pharmaceutical Development Support Center for its development.
Daiichi Sankyo is committed to making unapproved and off-label drugs with high medical needs available to the patients who are waiting for them to be approved.
* Working group held by the MHLW that aims to promote the development of drugs and indications not yet approved in Japan, but currently available in Europe and the U.S.
Product Outline
Launch date: June 19, 2017
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Product name
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Narurapid® Tablets 1 mg, 2 mg, 4 mg (immediate release formulation)
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Generic name(JAN)
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Hydromorphone hydrochloride
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Price
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Narurapid® Tablets 1 mg: 110.60 yen/tablet
Narurapid® Tablets 2 mg: 202.80 yen/tablet
Narurapid® Tablets 4 mg: 371.90 yen/tablet
(Date of listing in the NHI reimbursement price list in Japan: May 24, 2017)
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Indication
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Analgesic for moderate to severe cancer pain
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Dosage and administration
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For adults under normal conditions, 4-24 mg of hydromorphone is taken orally 4-6 times a day. Adjust dosage according to symptoms.
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Approved for manufacture
and marketing
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March 30, 2017
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Manufacture and marketing
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Daiichi Sankyo Propharma Co., Ltd.
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Marketing
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Daiichi Sankyo Co., Ltd.
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Launch date: June 19, 2017
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Product name
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Narusus® Tablets 2 mg, 6 mg, 12 mg, 24 mg (once daily extended release formulation)
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Generic name (JAN)
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Hydromorphone hydrochloride
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Price
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Narusus® Tablets 2 mg: 202.80 yen/tablet
Narusus® Tablets 6 mg: 530.20 yen/tablet
Narusus® Tablets 12 mg: 972.20 yen/tablet
Narusus® Tablets 24 mg: 1,782.80 yen/tablet
(Date of listing in the NHI reimbursement price list in Japan: May 24, 2017)
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Indication
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Analgesic for moderate to severe cancer pain
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|
Dosage and administration
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For adults under normal conditions, 4-24 mg of hydromorphone is taken orally once a day. Adjust dosage according to symptoms.
|
|
Approved for manufacture and marketing
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March 30, 2017
|
|
Manufacture and marketing
|
Daiichi Sankyo Propharma Co., Ltd.
|
|
Marketing
|
Daiichi Sankyo Co., Ltd.
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About Daiichi Sankyo Opioid Analgesics
Daiichi Sankyo contributes to the total care for the life of patients with cancer by providing opioid analgesics. In addition to Narurapid® Tablets (immediate release formulation) and Narusus® Tablets (once daily extended release formulation), Daiichi Sankyo has filed an application for a hydromorphone hydrochloride injection in Japan. Daiichi Sankyo launched oxycodone extended release tablets "Daiichi Sankyo" for sustained cancer pain treatment in March 2017 and has received approval for oxycodone immediate release tablets in Japan. Daiichi Sankyo believes that expanding our product lineup of opioid analgesics helps patients with cancer to improve their quality of life by relieving pain and supports patients living with cancer.