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Home Industry News ProStrakan receives positive CHMP opinion for Abstral

ProStrakan receives positive CHMP opinion for Abstral

1st July 2008

ProStrakan has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion recommending the approval of Abstral (fentanyl), formerly branded as Rapinyl, as a treatment for breakthrough cancer pain.

The company plans to launch the fast-dissolving sub-lingually administered tablet in the EU by the end of the year, following its initial introduction in Sweden in the third quarter of this year.

Abstral is intended for use by cancer patients already receiving opioid analgesics for the management of breakthrough cancer pain.

ProStrakan has in-licensed the exclusive European results to Rapinyl from Orexo.

The firm estimates over five million people in Europe have cancer, with 30 per cent suffering pain as a result and 65 per cent of these patients experiencing breakthrough cancer pain.

Dr Wilson Totten, chief executive of ProStrakan, said; “Abstral will play a major role in the further development of our European business while, at the same time, providing clinicians with a patient friendly formulation of fentanyl to prescribe to cancer patients suffering from breakthrough pain.”

He added the partnership with Orexo has proved valuable for ProStrakan and reiterated plans to roll out the drug as it receives further national marketing authorisations.

In March 2008, ProStrakan reported the receipt of marketing authorisation for Abstral in Sweden, which is the reference member state for wider regulatory filing of the drug in the EU.

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