The USA's Cephalon says that Effentora, the firm's treatment for breakthrough cancer pain (BTCP), has received European regulatory approval.

Effentora (fentanyl buccal), which was approved in the USA in September 2006 as Fentora, is indicated for the treatment of breakthrough cancer pain in adult patients who are already receiving maintenance opioid therapy for chronic pain. The go-ahead allows Cephalon to market Effentora in the 27 member states of the European Union, as well as Iceland and Norway.

The company noted that BTCP is characterised by its rapid onset, moderate-to-severe intensity, and its relatively short duration. Studies have demonstrated that an estimated 51%-89% of patients with cancer who are taking around-the-clock opioid therapy for their underlying persistent pain will experience breakthrough pain.

The approval was based on two crossover studies involving a total of 248 cancer patients who experienced between one and four episodes of breakthrough pain per day and who were already taking maintenance opioid therapy. An extension study has demonstrated safety and tolerability in 197 patients followed over a six-month period.

However there has been some controversy surrounding the drug in the USA where last September the Food and Drug Administration issued a public health advisory alerting health care professionals and consumers to reports of adverse events, including deaths, in patients taking Fentora. The deaths “were the result of improper selection of patients, dosing, or improper product substitution”, the agency said at the time.

Nevertheless, the firm is certain of the safety of the product when used correctly. Alain Aragues, president of Cephalon Europe, said the company continues to build its presence in Europe, the Middle East and Africa and activities are ongoing to make Effentora available quickly in the EU member countries."