The European Commission has granted marketing authorisation for Effentora, a buccal tablet formulation of fentanyl, according to its manufacturer Cephalon.
Effentora is designed for the treatment of breakthrough cancer pain in adult patients who are already receiving maintenance opioid therapy for chronic pain.
The approval allows Cephalon to market the drug in the 27 member states of the European Union, as well as Iceland and Norway.
Breakthrough cancer pain is characterised by its rapid onset, moderate-to-severe intensity and relatively short duration.
Research studies have shown that up to 89% of cancer patients who are taking around-the-clock opioid therapy for their underlying persistent pain will experience breakthrough pain.
“We are committed to bring new medications to the European markets that address the needs of patients with cancer for effective supportive care treatment, including pain management,” said Alain Aragues, President Cephalon Europe.
Effentora uses the proprietary OraVescent drug delivery technology to permit absorption of the opioid fentanyl across the inner lining of the cheek at a rate designed to match the onset of a breakthrough pain episode.
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