FDA Accepts Cephalon’s Fentora Supplemental Application

Cephalon has said that the FDA has accepted the company’s supplemental new drug application for Fentora for the management of breakthrough pain in opioid-tolerant patients with chronic pain.

In addition, the FDA notified the company that it will convene an advisory committee panel on May 6, 2008, to consider this application.

Included in the Fentora (fentanyl buccal tablet) [C-II] supplemental new drug application (sNDA) are data from three randomized, placebo- controlled clinical trials and one long-term open-label safety study. The sNDA provides an evaluation of the onset of pain relief from ten minutes to two hours, and has information regarding bioequivalence data for two routes of administration.