The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion recommending approval of Rapinyl (sublingual fentanyl) for breakthrough cancer pain.
Rapinyl, also known as Abstral, will be launched in Sweden in the third quarter of 2008, and across Europe from the end of 2008, under the bran name Abstral.
Abstral, manufactured by Swedish pharmaceutical company Orexo, is a fast-disintegrating tablet for sublingual administration of fentanyl, a powerful analgesic.
Of the five million people in Europe living with cancer, about 30% suffer pain, and 65% of these have breakthrough cancer pain. It is called “breakthrough” because it “breaks through” regular pain relief medicine schedules.
Abstral wias referred to the CHMP for review in September 2007, and in March 2008, Abstral received a Marketing Authorisation for Sweden, which was the Reference Member State (RMS) for the product during the decentralised procedure.
Commenting on Abstral´s European approval, Dr Torbjörn Bjerke, President and Chief Executive of Orexo, said:
“The approval is a fantastic achievement for Orexo and our ability to become a profitable pharmaceutical company. I believe that Abstral will play a major role in the treatment of cancer patients suffering from breakthrough pain.”