Strong Ph III data for Cephalon's Fentora

US drugmaker Cephalon has reported positive results from a 12-week, Phase III trial of Fentora (fentanyl buccal tablet) in patients with breakthrough pain associated with a broad range of chronic non-cancer pain conditions. According to the firm, the study achieved statistical significance on the primary endpoint - the Sum of Pain Intensity Differences from five to 60 minutes. Results across the 12 weeks of treatment showed both statistically-significant and clinically-relevant outcomes for patients with breakthrough pain who were already receiving and who were tolerant to opioid therapy for their underlying persistent pain.

The agent is currently approved only for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. "These data show similar positive outcomes as those with Fentora in treating breakthrough pain in opioid-tolerant patients with cancer, chronic neuropathic pain, and chronic low-back pain," said Lesley Russell, executive vice president, worldwide medical and regulatory operations. "We plan to submit these data to the Food and Drug Administration in the fourth quarter as part of our supplemental New Drug Application," he added.