Cephalon Files European Application for Fentanyl Buccal Tablet

Cephalon announced it has filed a marketing application with the European Medicines Agency (EMEA) for approval of its fentanyl effervescent buccal tablet. In the U.S., the tablet is sold under the trade name Fentora. If approved, the centralized filing of the application would allow Cephalon Europe to market the product in 29 European countries.

The FDA approved Fentora in September 2006 for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for persistent cancer pain. The drug is the first tablet formulation of fentanyl and the first buccal tablet approved for cancer-related breakthrough pain.

The sugar-free tablet is placed between the upper cheek and gum above a rear molar tooth. When it comes into contact with saliva, the drug's delivery system generates a reaction leading to the release of carbon dioxide. It is believed that transient pH changes accompanying this reaction may optimize how well the tablet dissolves and how quickly the medicine passes across the buccal mucosa. Conventional short-acting oral opioids are swallowed and absorbed in the gastrointestinal tract, which can take up to 30 to 45 minutes. With Cephalon's drug-delivery technology, approximately half of the drug dose is absorbed directly across the lining of the upper cheek and into the bloodstream more quickly than if it were swallowed.