Cephalon announces application for EU approval of Fentora

Cephalon has announced that the firm has submitted an application for marketing approval of Fentora (fentanyl buccal tablet) with the European Agency for the Evaluation of Medicinal Products.

This application follows approval for the drug by the US Food and Drug Administration last September for the treatment of breakthrough pain in cancer patients exhibiting tolerance to opioid therapy for persistent pain.

Breakthrough pain refers to temporary flare-ups of moderate-to-severe pain that interrupts persistent pain felt by patients. Cancer patients typically suffer four episodes of such pain daily lasting for half an hour to an hour.

“Fentora was launched in the US market in October 2006 and is the first tablet formulation of fentanyl and the first buccal tablet approved for cancer-related breakthrough pain,” the company reports.

Cephalon adds that it is currently engaged in an ongoing programme of clinical development for the compound in order to investigate potential additional indications for the drug.

In January 2007, the company announced the positive results of two phase III clinical trials investigating the use of Fentora as a treatment for breakthrough pain in opioid-tolerant cancer patients.

The trials showed that the onset of pain relief in patients administered with the compound occurred within ten minutes.