OREANDA-NEWS. March 23, 2012. Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that it will develop hydromorphone hydrochloride, a narcotic analgesic that has yet to be approved in Japan.


Hydromorphone hydrochloride is an opiate, narcotic analgesic that has been available outside of Japan for over 80 years. Although it is the standard for pain management for cancer pain treatment according to WHO guidelines, hydromorphone hydrochloride has yet to be approved in Japan.

Mundipharma K.K. had been requested by the Study Group on Unapproved and Off-label Drugs of High Medical Need* to develop hydromorphone hydrochloride in Japan, but after subsequent discussions it was decided that Daiichi Sankyo would develop the drug instead. The development of hydromorphone hydrochloride will contribute to the improvement of pain management options in Japan, and Daiichi Sankyo, through its commitment to corporate social responsibility, will continue to work to make unapproved and off-label drugs available in Japan in order to further contribute to medical treatment options for patients.


*A study group set up by Japan’s Ministry of Health, Labour and Welfare to promote development by pharmaceutical companies of unapproved and off-label drugs in Japan that have been approved in the United States and Europe.