ProStrakan Group has received marketing authorization from the German regulatory authority for Abstral for breakthrough cancer pain.
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ProStrakan now plans to launch Abstral in Germany and the UK in the first few weeks of 2009, with further launches across Europe during the year.
Abstral (formerly branded as Rapinyl) is a fast-dissolving tablet for sub-lingual administration of fentanyl, intended for the management of breakthrough cancer pain in patients who are already receiving opioid analgesics, the company said.
ProStrakan has in-licensed the exclusive rights to this product in Europe and North America from the Swedish pharmaceutical company, Orexo.
Wilson Totten, CEO of ProStrakan, said: “Germany is an important market for Abstral and its approval by the German regulatory authority is a significant step forward towards its launch there. 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.”
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