CEPHALON FILES NEW DRUG APPLICATION FOR ORAVESCENT FENTANYL

Cephalon has filed a new drug application with the FDA, seeking approval to market a fentanyl effervescent 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 pain.

The tablet delivers the opioid fentanyl through the oral mucosa utilizing a proprietary enhanced absorption technology, OraVescent. Upon approval, Cephalon intends to commercialize OraVescent fentanyl in multiple dosage strengths (100-, 200-, 400-, 600-, and 800-micrograms).