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Home Industry News Cephalon drug receives EC approval for breakthrough cancer pain

Cephalon drug receives EC approval for breakthrough cancer pain

15th April 2008

Cephalon has announced that Effentora (fentanyl buccal tablet) has received marketing authorisation from the European Commission (EC) as a treatment for breakthrough cancer pain.

The compound is now indicated in Europe as a treatment for breakthrough caner pain in adult patients who are already prescribed with maintenance opioid therapy for chronic pain.

Effentora uses the proprietary OraVescent drug delivery technology to enable the absorption of the active ingredient through the buccal mucosa (cheek lining) at a rate that matches the onset of an episode of breakthrough pain.

The safety and efficacy of the drug have been confirmed by two placebo-controlled studies involving 248 cancer patients with breakthrough pain.

Alain Aragues, president of Cephalon Europe, said: “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.”

He added that the firm is looking to expand its presence in Europe, the Middle East and Africa and is currently working to make Effentora speedily available in EU countries.

In January 2008, Mr Aragus said that once approved, Effentora would be an exciting addition to the company’s product portfolio in Europe and bring significant benefit to patients.

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