FDA APPROVES CEPHALON'S FENTANYL BUCCAL TABLET

Cephalon announced it has received approval from the FDA to market Fentora (fentanyl buccal tablet) for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their persistent cancer pain. Fentora is the first and only buccal tablet approved for this indication and is the second new product to be marketed by Cephalon this year. Cephalon expects the drug to be available in the United States during the first week of October.

The sugar-free tablet is placed between the upper cheek and gum above a rear molar tooth. When it comes into contact with saliva, Fentora's OraVescent 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 Fentora dose is absorbed directly across the lining of the upper cheek and into the bloodstream more quickly than if it were swallowed.

In placebo-controlled trials, patients treated with Fentora showed a statistically significant improvement on the primary end point, the Sum of Pain Intensity Differences, and some patients experienced clinically significant decreases in pain intensity and greater pain relief within 15 minutes, the first time point measured. Cephalon will manufacture the drug in five dosage strengths: 100, 200, 400, 600 and 800 micrograms.