For Immediate Release

2018.05.16

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 Koji Ogawa, Corporate Officer,
Vice President, Corporate Communications Department
Telephone: +81-3-6225-1126
http://www.daiichisankyo.com

Daiichi Sankyo Launches NaruveinⓇ Injection for Cancer Pain Treatment in Japan

Tokyo, Japan (May 16, 2018) –Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced today that it has launched in Japan an injection for cancer pain treatment: Naruvein Injection 2 mg • 20 mg (generic name: hydromorphone hydrochloride).

 

Hydromorphone hydrochloride is an opium-based narcotic analgesic that has been sold for more than 80 years outside Japan and positioned as the standard drug for pain management in the World Health Organization (WHO) guidelines for cancer pain treatment.

 

Joining the currently marketed extended-release formulation, Narusus Tablets, and immediate-release formulation, Narurapid Tablets, the injection formulation, Naruvein Injection, is a new addition to Daiichi Sankyo’s analgesic line-up to help meet the diverse needs of patients and health care professionals in Japan.

 

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.

 

 

* A committee held by Japan’s Ministry of Health, Labour and Welfare 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: May 16, 2018

Product name

Naruvein Injection 2mg・20mg

Generic name(JAN)

Hydromorphone hydrochloride

Price

Naruvein Injection 2 mg: One 1-mL vial: 725 yen

Naruvein Injection 20 mg: One 2-mL vial: 6,340 yen

 (Date of listing in the NHI reimbursement price list in Japan: April 18, 2018)

Indication

Analgesic for moderate to severe cancer pain

Dosage and administration

For adults under normal conditions, 0.5-25 mg per day as hydromorphone is continuously administered intravenously or subcutaneously. Adjust dosage according to symptoms.

Approved for manufacture

and marketing

January 19, 2018

Manufacture and marketing

Daiichi Sankyo Propharma Co., Ltd.

Marketing

Daiichi Sankyo Co., Ltd.

 

 

About Daiichi Sankyo Opioid Analgesics

Daiichi Sankyo contributes to the total care for the life of patients with cancer by providing opioid analgesics. A diverse line-up of narcotic analgesic drugs supports patients living with cancer by relieving pain and improving QOL. In Japan, in addition to the hydromorphone chloride preparations, Narusus Tablets (extended-release formulation), Narurapid Tablets (immediate-release formulation), and Naruvein Injection (injection formulation), Daiichi Sankyo also markets the oxycodone hydrochloride preparations, Oxycodone Extended Release Tablets Daiichi Sankyo (extended-release formulation) and Oxycodone Tablets Daiichi Sankyo (immediate-release formulation).