Cephalon reports positive Fentora clinical trial results

Cephalon has announced positive results from a phase III clinical study assessing Fentora (fentanyl buccal tablet) [C-II] as a treatment for breakthrough pain related to a wide range of chronic non-cancer pain indications

The company notes that the trial reached statistical significance on its primary endpoint, with the drug showing clinically relevant outcomes for patients tolerant to opioid therapy over 12 weeks of treatment.

At present, Fentora is approved for pain management in patients with cancer who are tolerant to opioid therapy for underlying persistent pain relating to their disease.

Dr Lesley Russell, executive vice-president of worldwide medical and regulatory operations at Cephalon, said: “We are excited to complete our phase III programme with this third and final controlled study.

“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.”

She added that the firm plans to submit this trial data to the US Food and Drug Administration in the fourth quarter of the year as part of a supplemental new drug application for the compound.

In February 2007, Cephalon submitted an application for marketing approval for the drug with the European Medicines Agency following its US launch in October 2006.