Cephalon pain drug receives positive CHMP opinion

Cephalon has announced that it has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency for its breakthrough pain drug Effentora (fentanyl buccal tablet).

The compound was submitted to European regulators in March 2007 as a treatment for breakthrough pain in adult cancer patients already receiving treatment with maintenance opioid therapy for their chronic cancer pain.

Cephalon reports that the positive CHMP recommendation for the compound will be passed on to the European Commission, with final marketing approval expected within two to three months.

Alain Aragues, president of Cephalon Europe, said: “We believe this product, once approved, will be an exciting addition to our European product portfolio and will provide a tremendous benefit to patients suffering from breakthrough cancer pain.”

He added that the company is dedicated to launching novel pain drugs to the market in Europe and is pleased to receive this positive CHMP opinion for Effentora.

The compound was approved in the US under the Fentora trade name in September 2006.

In November 2007, Cephalon quoted a report in the August 2006 issue of the Journal of Pain that found that 74 per cent of patients suffering from non-cancer chronic pain experience breakthrough pain, adding that new treatment options in this field are to be welcomed.