Thursday, November 15, 2012

Kyowa Hakko Kirin files KW-2246 (fentanyl citrate sublingual tablet) a treatment for cancer pain for approval in Japan

 KW-2246, which is to be administered sublingually, is a treatment for sudden pain (breakthrough pain) that occurs during chronic cancer pain management. An application was made for marketing approval on February 24, 2010, but the application was withdrawn as the regulators required additional clinical data.  The efficacy and safety of this drug has been confirmed in the additional trials, and subsequently the company is filing this approval application for marketing in Japan.

KW-2246, was licensed from Orexo Inc and .has been sold abroad under several names, including "Abstral®. In Europe.  ProStrakan, a subsidiary of Kyowa Hakko Kirin, sells this drug under the name of "Abstral® This drug will be jointly distributed in Japan with Hisamitsu Pharmaceutical Co., Inc.

In the field of treatment for cancer pain, Kyowa Hakko Kirin and Hisamitsu Pharmaceutical have been jointly selling Fentos® Tape (fentanyl citrate transdermal absorption product) since June 2010



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