ProStrakan provides R&D update

Scotland-based specialty pharmaceutical firm ProStrakan has provided an update on the progress of its Rapinyl (fentanyl) and Xomolix (droperidol), now undergoing the European Union approval processes, following a European Medicines Agency (EMEA) meetings.

It notes that Rapinyl, for breakthrough cancer pain, entered the EU Decentralized Procedure last year. Of the 25 member states involved in the DCP for the drug, 21 consider it to be approvable. Because consensus among all member states has been required in the process so far, the product will now be referred for review by the EMEA's Committee for Medicinal Products for Human Use (CHMP), where a majority decision is sufficient to gain approval. The exact timings of the CHMP process are not yet clear, but ProStrakan believes that this will extend into 2008. First launches are now likely to commence from the end of 2008.

Xomolix, for post-operative nausea and vomiting, has now successfully completed the DCP. Droperidol is already marketed in eight European countries, including France, the Netherlands and Portugal. This news means ProStrakan can market the drug across other EU markets, including Germany, Italy and Spain, once national licenses have been issued. It intends to commence EU launches next year.