ProStrakan’s Abstral receives German marketing approval

ProStrakan has said its cancer drug Abstral has received a marketing authorisation from the German regulatory authority (BfArM).

The company now plans to launch the drug in the country and the UK in first few weeks of 2009, with further releases in other EU countries planned for the rest of the year.

Formerly branded as Rapinyl, the drug is a fast-dissolving tablet for sub-lingual administration of fentanyl.

It is intended for the management of breakthrough cancer pain in patients who are already receiving opioid analgesics.

Dr Wilson Totten, chief executive of ProStrakan, said Germany is an “important market” for Abstral, describing the approval by BfArM as a “significant step” towards the drug’s launch.

“Our German operation is well advanced in its preparations for launch and we look forward to introducing German oncologists to this important product for cancer patients suffering from the debilitating effects of breakthrough pain,” he added.

In August this year, the company and partner Orexo launched Abstral in Sweden.

Last month, ProStrakan has announced a partnership with Bayer Schering Pharma to develop a gel.

The exclusive licence is set to allow the companies to develop and commercialise Tostran – a two per cent testosterone gel used for the hormone’s replacement in hypogonadal men.