ProStrakan announces continued European support for Rapinyl

ProStrakan has announced that Rapinyl, its fast-dissolving tablet for sub-lingual administration of fentanyl, has continued support in Europe.

The compound has received marketing authorisation in Sweden as a treatment for breakthrough cancer pain, where it will be branded as Abstral.

Sweden is the reference member state for the wider regulatory filing of the compound in the EU and has opted to make its marketing authorisation decision for Sweden alone based on its assessment report.

ProStrakan forecasts that the regulatory procedure for the drug will be completed in Europe during 2008.

Dr Wilson Totten, chief executive of ProStrakan, said: “The Swedish regulatory authority’s decision to issue a marketing authorisation for Rapinyl (Abstral) while the EU regulatory procedure is still under way underlines their continued support for Europe-wide approval of this product.

The company has in-licensed exclusive rights to the drug in Europe from Orexo.

Rapinyl will be marketed in Sweden through a joint venture from both companies, with a launch forecast for the third quarter of this year.

Earlier this year, ProStrakan announced that Endo Pharmaceuticals had reported positive phase III results in a US trial of Rapinyl, with the drug reaching its primary endpoint of the sum of pain intensity difference from baseline to 30 minutes.