On June 19, 2017 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported 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) (Press release, Daiichi Sankyo, JUN 18, 2017, View Source [SID1234519621]).

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
Product name
Narurapid Tablets 1 mg, 2 mg, 4 mg (immediate release formulation)
Generic name(JAN)
Hydromorphone hydrochloride
Price
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)
Indication
Analgesic for moderate to severe cancer pain
Dosage and administration
For adults under normal conditions, 4-24 mg of hydromorphone is taken orally 4-6 times a day. Adjust dosage according to symptoms.
Approved for manufacture
and marketing
March 30, 2017
Manufacture and marketing
Daiichi Sankyo Propharma Co., Ltd.
Marketing
Daiichi Sankyo Co., Ltd.

Launch date: June 19, 2017
Product name
Narusus Tablets 2 mg, 6 mg, 12 mg, 24 mg (once daily extended release formulation)
Generic name (JAN)
Hydromorphone hydrochloride
Price
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)
Indication
Analgesic for moderate to severe cancer pain
Dosage and administration
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
March 30, 2017
Manufacture and marketing
Daiichi Sankyo Propharma Co., Ltd.
Marketing
Daiichi Sankyo Co., Ltd.

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