Health Canada accepts AbstralTM New Drug Submission for review

“AbstralTM is currently helping thousands of patients in Europe and the submission in Canada is another important step towards international marketing of the product.”

Orexo AB (STO:ORX) today confirms that its partner, ProStrakan Group plc (LSE: PSK) has announced that the New Drug Submission made by their Canadian partner, Paladin Labs Inc., for AbstralTM has been accepted for review by Health Canada, the Canadian Government Department with responsibility for public health.

AbstralTM, developed by Orexo AB 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.

Commenting on today’s announcement, Torbjörn Bjerke, Orexo’s President and CEO, said: “AbstralTM is currently helping thousands of patients in Europe and the submission in Canada is another important step towards international marketing of the product.”