Regulatory Status of the Buccal Fentanyl sNDA Updated

The US Food and Drug Administration (FDA) has accepted Cephalon's supplemental New Drug Application (sNDA) for fentanyl buccal tablets (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.

Application on Schedule

"We are pleased that the Fentora application remains on schedule with an FDA action date of September 13, 2008," said Dr. Lesley Russell, executive vice president, Worldwide Medical and Regulatory Operations. "Fentora is the first medication that has been evaluated in controlled clinical trials for the management of breakthrough pain in opioid-tolerant patients with chronic pain. Therefore, it is not surprising that the agency decided to convene a panel to consider data on the use of Fentora beyond the initial indication for breakthrough pain in cancer patients."

The Fentora sNDA is based on three randomized, placebo-controlled clinical trials and one long-term open-label safety study, including data from opioid-tolerant patients with chronic low back and neuropathic pain. The sNDA provides an evaluation of the onset of pain relief from 10 minutes to 2 hours, and has information regarding bioequivalence data for two routes of administration.

In 2006, buccal fentanyl and an accompanying Risk Minimization Action Plan (RiskMAP) were approved by the FDA only for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. The company developed and maintains a Fentora RiskMAP to address the appropriate patient selection, dosing, and administration of the medication.