Orexo confirms FDA acceptance of Abstral filing
Uppsala, Sweden, 6th October, 2009 - Orexo AB (STO: ORX) today confirms that its partner, ProStrakan Group plc (LSE: PSK), has announced that the New Drug Application (NDA) filing for Abstral has been accepted for review by the US Food and Drug Administration (FDA). Abstral 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. Subject to successful completion of the US approval process,