Cephalon files Fentora sNDA with FDA

US biopharmaceutical firm Cephalon has filed a supplemental New Drug Application with the Food and Drug Administration, seeking clearance to market Fentora (fentanyl buccal tablet) for the management of breakthrough pain in opioid resistant patients. The drug was approved last year for the treatment of breakthrough cancer pain (Marketletter October 2, 2006).

Cephalon said that the sNDA includes data from three, randomized placebo-controlled trials and one long-term safety assessment. Participants with a range of chronic conditions, including lower back and neuropathic pain, were treated for up to 18 months. The results showed that opioid tolerant patients who received treatment achieved significant improvements in terms of both relief from breakthrough pain and the duration of this effect.

Lesley Russell, executive vice president of worldwide medical regulatory operations as Cephalon, said: "clinical trials supporting this submission mark the first time a pain medication has been evaluated as a treatment for breakthrough pain associated with serious chronic pain conditions other than cancer." The FDA is expected to issue a final decision on the sNDA in the next 10 to 12 months.