Orexo AB (STO:ORX) today announces that ProStrakan's partner, Paladin Labs Inc. has been informed by Health Canada, the Canadian Government Department with responsibility for public health, that it has approved Abstral®.
Abstral is a rapidly-disintegrating, sublingual (under the tongue) formulation of fentanyl. The product is approved for the treatment of breakthrough pain in patients receiving opioid analgesics for underlying chronic cancer pain.
Orexo has out-licensed the rights for Abstral in Europe and North America to ProStrakan. The rights to the Canadian markets were sub-licensed by ProStrakan to Paladin in 2008. Orexo will receive royalty on sales in Canada and payment on achievement of certain sales targets.
Abstral was in January 2011 approved by the US Food and Drug Administration, where ProStrakan plans to launch this product in Q1 2011.
Anders Lundström, Orexo's President and CEO, said: "We are very pleased to be able to announce this approval. The Canadian pharmaceutical market is significant - one of the top 10 markets in the world, and one of the fastest growing. We are confident that Paladin will be an excellent partner for ProStrakan and Orexo in enabling Canadian patients suffering from breakthrough cancer pain to get better relief with Abstral. This is another important step for Orexo in providing the right solutions to pain for clinicians and their patients."
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