Rapinyl™ has received Swedish Marketing Authorization
Rapinyl™ is a fast-dissolving tablet for sublingual administration of fentanyl intended for the treatment of breakthrough cancer pain, for which ProStrakan Group plc, the international specialty pharmaceutical company, has in-licensed exclusive rights in Europe from Orexo. ProStrakan today announces that it has received Marketing Authorization in Sweden for Rapinyl™.
Sweden is the reference member state (RMS) for the wider EU regulatory filing of Rapinyl™. The Swedish Medical Products Agency has taken the decision to issue a Marketing Authorization for Sweden alone based on its assessment report made as RMS for the EU regulatory procedure.
ProStrakan expects that the wider EU regulatory procedure will complete during 2008. Meanwhile, it is anticipated that the product, branded as “Abstral”, will be launched in Sweden in Q3 2008. Abstral will be marketed in Sweden through Orexo´s joint venture with ProStrakan, which operates in the Nordic countries.
“This is an important milestone for Orexo and our late stage product portfolio. The Swedish regulatory authority’s decision to issue a Marketing Authorization for Rapinyl™ (Abstral) while the EU regulatory procedure is still under way underlines their continued support for Europe-wide approval of this product”, said Dr Torbjörn Bjerke, President & CEO of Orexo.
For more information, please contact:
Torbjörn Bjerke, President and CEO, Orexo AB
Tel: +46 (0)708-66 19 90
Claes Wenthzel, Executive Vice President & CFO, Orexo AB
Tel: +46 (0)18-780 88 44