EMEA-approved drug, Abstral, is being prepared for Japanese and U.S. regulatory filings.
Kyowa Hakko Kirin, Orexo’s Japanese development partner for the breakthrough cancer pain drug, KW-2246, reported positive results from a Phase III trial in Japan. The company is now preparing to submit an NDA to Japanese authorities.
KW-2246 has already been approved under the brand name Abstral™ in Europe and is expected to be submitted for approval in the U.S., under the name Rapinyl, later this year. Abstral/Rapinyl is a sublingual preparation of fentanyl, developed using Orexo’s patented sublingual tablet technology.
The drug was approved in Europe during 2008 and has been launched in Sweden, the U.K., and Germany and is ready for launch in France and Spain. ProStrakan is Orexo’s licensee for the product in the EU and U.S. ProStrakan took over U.S. rights to the drug from Endo in July 2008.
Orexo has also signed distribution agreements for Abstral/Rapinyl in other major global markets including Southeast Asia (distrubiton partner Hospira), China (NovaMed), Israel (Neopharm), as well as CIS (Russia and other countries in the former Soviet Union), Bulgaria, and Romania (Gedeon Richter).