Archimedes Pharma Ltd. was granted marketing authorization from the European Commission for its lead product, PecFent, a fentanyl nasal spray for the treatment of breakthrough cancer pain (BTCP) in adults who are already receiving maintenance opioid therapy for chronic cancer pain. BTCP is sudden, unpredictable episodes of pain that are severe to excruciating in intensity. BTCP affects 24% to 95% of all cancer patients despite background pain medication.

PecFent contains fentanyl, a highly potent opioid analgesic, and uses Archimedes’ PecSys nasal drug delivery system to deliver fentanyl in a rapid but controlled manner designed to match the time course of the typical breakthrough pain episode. The marketing authorization is based on three Phase III studies in more than 650 patients. Results from two randomized, double blind, Phase III trials, show PecFent demonstrated onset of pain relief as early as five minutes as well as clinically meaningful pain relief within 10 minutes.

Jeffrey H. Buchalter, president and chief executive officer of Archimedes Pharma, commented, “The grant of European marketing authorization for PecFent provides a new therapy to improve the treatment options for adult patients with breakthrough cancer pain. This is also a transformative milestone for Archimedes Pharma as we have established commercial operations in Europe and look forward to launching PecFent in major European markets in the coming months.”

The company submitted a NDA with the FDA in August 2009 and is in the process of establishing a commercial organization to market the drug in the U.S.