Rapinyl receives further EU marketing approval

4 Mar 2009

Cancer painkiller Abstral (rapinyl) has received marketing authorisation from the French and Spanish regulatory authorities for the treatment of breakthrough cancer pain.

Abstral is expected to be launched during the second half of 2009 in France and Spain, the two new approvals mean that Abstral has been approved in five European markets including Sweden, the UK and Germany since March of 2008, with further approvals anticipated in 2009. The approvals in France and Spain trigger milestone payments of EUR 1.3 million to manufacturers Orexo.

Commenting on the news, Torbjörn Bjerke, President and CEO of Orexo, said "Abstral is a very important product for helping cancer patients manage their pain and with this approval patients across the majority of the European market can now benefit from the product. The royalty stream that this product will generate will bring us closer to our goal of becoming a sustainable, profitable pharmaceutical company. ProStrakan is doing an excellent job of rolling out Abstral to the major European markets, and together we are anticipating to be in a position to file for USA approval for the product in 2009. We look forward to continuing our successful partnership with ProStrakan in Europe and North America in the near future."

Abstral is a sublingual (under the tongue) tablet for the fast administration of fentanyl, an opioid commonly used to treat breakthrough cancer pain in patients who are already receiving opioid analgesics. Abstral received a positive recommendation for approval in Europe by the EMEA's Committee for Medicinal Products for Human Use in June 2008. It is currently launched in reference country Sweden, the UK and Germany.