Kyowa Hakko Kirin, Orexo's partner, has filed a new drug application (NDA) seeking Japanese approval for KW-2246 as cancer pain medication.
The sublingual formulation of fentanyl earlier gained approval in US, EU and Canada as cancer pain therapy in patients already taking opioid analgesics.
The company confirmed the efficacy and safety profile of the product in various trials before submitting the application.
Kyowa Hakko Kirin and Hisamitsu Pharmaceutical will jointly commercialize and market KW-2246 in Japan.