Scotland-based ProStrakan announced mixed news this morning regarding the regulatory progress of its cancer pain therapy Rapinyl and sickness drug Droperidol.
It looks like the launch of its “breakthrough” cancer pain drug Rapinyl (fentanyl) will now be delayed because the process for obtaining the green light has been extended.
Only 21 of the 25 member states considered the product to be approvable and, because a unanimous vote is required for full clearance, Rapinyl has been referred for review by the European Medicines Agency’s Committee for Medicinal Products for Human Use, where a majority decision is sufficient to gain the regulatory nod, the group explained.
ProStrakan said that, although it is still unsure of the time it will take the CHMP to complete its review, it believes the process will extend into 2008, and first launches are now likely to be put back to the end of next year.
Nod for Droperidol
Meanwhile, there was better news regarding Droperidol (xomolix), which has now completed the European Decentralised Procedure and thereby obtained a single marketing authorisation valid across the EU.
The drug is already marketed in eight European countries for the prevention and treatment of post-operative nausea and vomiting, and the group says it intends to kick off further launches in 2008.