Archimedes Pharma Receives European Marketing Authorisation for PecFent for the Treatment of Breakthrough Cancer Pain
Archimedes Pharma Ltd. announced that the European Commission has granted marketing authorisation 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.
Breakthrough cancer pain is sudden, unpredictable episodes of pain that are severe to excruciating in intensity; it affects 24% to 95% (average 62%) of all cancer patients despite background pain medication. Episodes can often reach maximum intensity in five minutes typically lasting 30-60 minutes.ii Most people who have breakthrough cancer pain experience several episodes a day.
PecFent contains fentanyl, a highly potent opioid analgesic and uses an Archimedes Pharma nasal drug delivery system (PecSys™) to deliver fentanyl in a rapid but controlled manner designed to match the time course of the typical breakthrough pain episode. In two randomized, well-controlled, double blind, phase III clinical trials, 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 authorisation 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.”
Archimedes Pharma submitted a New Drug Application (NDA) for the product to the US Food and Drug Administration (FDA) in August 2009 and is in the process of establishing a US commercial organisation to market the drug in the US once approved.
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