FDA Accepts Abstral NDA Filing For Review

Orexo said that its partner ProStrakan has reported that the New Drug Application (NDA) filing for Abstral has been accepted for review by the FDA.

Abstral is a 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.

Reportedly, the drug is based on Orexo’s patented sublingual tablet technology in which a dissolving tablet is placed under the tongue and the active substance is absorbed by the mucous membrane.

Moreover, subject to successful completion of the US approval process, ProStrakan plans to launch Abstral in the US in the second half of 2010.

Torbjorn Bjerke, president and CEO of Orexo, 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. We are very excited at the prospect of our partner ProStrakan launching Abstral in the second half of 2010.”