KHK files Abstral NDA in Japan


Orexo's partner, Kyowa Hakko Kirin (KHK) has submitted an NDA in Japan for Abstral (fentanyl [KW-2246]) sublingual tablet, developed for the treatment of breakthrough cancer pain. 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.

In February 2010, an NDA application covering Abstral was submitted for approval in Japan. The application was subsequently withdrawn and additional clinical trials were performed. Following confirmation of the product efficacy and safety in these trials, the current application has now been submitted.

In June 2012, Orexo renegotiated its Abstral agreement with ProStrakan, a subsidiary of KHK, and acquired all rights to Abstral in the US. ProStrakan acquired the corresponding rights in the EU and rest of the world, excluding Japan. Abstral will be jointly marketed and sold in Japan by KHK and Hisamitsu Pharmaceutical. The two companies have been jointly selling another cancer pain product, FentosTape (fentanyl citrate transdermal system), since June 2010.

This article is tagged to:
Sector: Medical Devices
Geography: Japan, Sweden