Orexo partner submits NDA for cancer pain drug Abstral in Japan

“The submission of KW-2246 in Japan is an important step in the international development of Orexo’s sublingual fentanyl product, in Europe launched under the brand AbstralTM. The success of Abstral is confirmed by its strong sales growth in Europe.”

Orexo AB (STO:ORX) today announces that its partner Kyowa Hakko Kirin Co., Ltd. has submitted the New Drug Application (NDA) in Japan for the cancer pain drug KW-2246 (Abstral).

Kyowa Hakko Kirin has confirmed KW-2246’s safety and efficacy in clinical trials conducted in Japan.

The drug will be marketed by Kyowa Hakko Kirin and Hisamitsu Pharmaceutical Co., Inc. Kyowa Hakko Kirin and Hisamitsu will also market HFT-290 (Fentanyl transdermal patch) under development by Hisamitsu.

Commenting on the announcement, Torbjörn Bjerke, Orexo’s President and CEO, said: “The submission of KW-2246 in Japan is an important step in the international development of Orexo’s sublingual fentanyl product, in Europe launched under the brand AbstralTM. The success of Abstral is confirmed by its strong sales growth in Europe.

This submission further strengthens that Orexos sublingual fentanyl product has the potential to be an important product for the treatment of severe pain episodes in cancer patients globally. The submission is a result of the continued strong commitment we see from our partner Kyowa Hakko Kirin in the Japanese market.”