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Trials & Filings

Abstral Launches in Japan

Sublingual pain med launched by KHK, Hisamitsu

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Orexo AB‘s partner, Kyowa Hakko Kirin Co., Ltd. (KHK), has launched Abstral in Japan. Abstral is a rapidly-disintegrating, sublingual rapid-acting formulation of fentanyl citrate, a well-established opioid, and is indicated for the management of breakthrough pain in cancer patients.

Kyowa Hakko Kirin (KHK) licensed the right for Abstral in Japan in 2003 and has completed a dedicated clinical development program for the product in the territory. Abstral will be jointly distributed by KHK and Hisamitsu Pharmaceutical Co., Inc. Orexo will receive a single digit royalty on net sales of Abstral in Japan.

The manufacturing and marketing approval of Abstral in Japan was received on September 20, 2013 ahead of expectations, and on November 19, 2013 Abstral was listed on the Japanese National Health Insurance Drug Price List. Abstral is also approved in the U.S., EU, and Canada.

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