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For Immediate Release
Company name: DAIICHI SANKYO COMPANY, LIMITED
Representative: George Nakayama, Representative Director, President and CEO
(Code no.: 4568, First Section, Tokyo Stock Exchange)
Please address inquiries to Noriaki Ishida, Executive Officer,
Vice President, Corporate Communications Department
Daiichi Sankyo Announces Manufacture and Sales Approval in Japan of Narurapid® Tablets and Narusus® Tablets for Cancer Pain Treatment
Tokyo, Japan (March 30, 2017) – Daiichi Sankyo Company, Limited (hereafter,“Daiichi Sankyo”) today announced that its Japan domestic group company, Daiichi Sankyo Propharma Co., Ltd. has received approval for the manufacture and sales in Japan of 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 treatments (generic name: hydromorphone hydrochloride).
Hydromorphone hydrochloride is an opiate, narcotic analgesic that has been available outside of Japan for over 80 years. It is the standard for pain management for cancer pain treatment according to foreign 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 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.
About Daiichi Sankyo Opioid Analgesics
Daiichi Sankyo contributes to the total care for the life of patients with cancer by providing opioid analgesics.
In Japan, Daiichi Sankyo has received approval for the manufacture and sales in Japan of Narurapid® tablets (immediate release formulation) and Narusus® Tablets (once daily extended release formulation), and filed application for injection of hydromorphone hydrochloride. Daiichi Sankyo launched oxycodone extended release tablets "Daiichi Sankyo" for sustained cancer pain treatment in March 2017 and received approval for oxycodone immediate release tablets.
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.