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, ProStrakan plans to launch Abstral in the US in the second half of 2010.
Commenting on today’s announcement, Torbjörn Bjerke, Orexo’s President and CEO, said: “FDA’s acceptance of the Abstral NDA filing is an important step towards bringing this product to the thousands of patients in the US that we believe will benefit from its effective and convenient formulation. The US is the world’s largest market for breakthrough cancer pain with the number of attacks amounting to approximately 376 million per year. We are very excited at the prospect of our partner ProStrakan launching Abstral in the second half of 2010”.
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