Orexo AB Announces Submission of a New Drug Application for KW-2246 (Abstral®) in Japan
Published: Nov 13, 2012
UPPSALA, Sweden--(BUSINESS WIRE)--Regulatory News: Swedish specialty pharmaceutical company Orexo (STO:ORX) today communicated that its partner Kyowa Hakko Kirin Co., Ltd has submitted a New Drug Application (“NDA”) in Japan for KW-2246 (Abstral), a fentanyl sublingual tablet developed for the treatment of breakthrough cancer pain. KW-2246 (Abstral) is a rapidly-disintegrating, sublingual (under the tongue) formulation of fentanyl. The product has previously been approved in the US, EU and Canada for the management of episodes of breakthrough pain experienced by cancer patients who already are receiving opioid analgesics for chronic pain.