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news.Orexo has confirmed that its partner, ProStrakan has announced that the New Drug Submission made by their Canadian partner, Paladin Labs, for Abstral has been accepted for review by Health Canada, the Canadian Government Department with responsibility for public health.
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Abstral, developed by Orexo is a new, rapidly disintegrating, sublingual formulation of fentanyl, a long-established opioid used for the management of episodes of breakthrough pain experienced by cancer patients who are already receiving opioid analgesics for their chronic pain.
The submission has been granted priority review status by Health Canada and review of the application is therefore expected to conclude in 180 days.
Torbjorn Bjerke, president and CEO of Orexo, said: “Abstral is currently helping thousands of patients in Europe and the submission in Canada is another important step towards international marketing of the product.”