Daiichi Sankyo Company, Limited 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) [generic hydromorphone hydrochloride] for cancer pain treatments.

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 US.

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.