Press release: Effentora, cancer pain drug, approved in European Union

The European Commission granted marketing authorization for a tablet formulation of the breakthrough cancer pain drug, fentanyl.

The approval allows Effentora to be marketed in the 27 member states of the European Union as well as Iceland and Norway.

Breakthrough cancer pain, an often debilitating condition, is characterized by its rapid onset, moderate-to-severe intensity and its relatively short duration. Research studies have demonstrated that as many as 89 percent of patients with cancer who are taking around-the-clock opioid therapy for persistent pain will experience breakthrough pain.

Effentora uses the company’s 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.

A tablet formulation of fentanyl, under the trade name Fentora, was approved in the United States by the Food and Drug Administration in 2006.

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