Cephalon Submits Fentora sNDA

Cephalon has submitted an sNDA to the FDA to market Fentora for the management of breakthrough pain in opioid tolerant patients with chronic pain conditions. Breakthrough pain is characterized by its rapid onset, moderate-to-severe intensity, and relatively short duration. According to a study published in the August 2006 issue of The Journal of Pain, as many as  74%of patients with non-cancer chronic pain conditions treated for persistent pain, such as chronic low back and chronic neuropathic pain, will experience breakthrough pain. Currently Fentora is approved 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 pain.

“The 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,” said Dr. Lesley Russell, Cephalon’s executive vice president, Worldwide Medical and Regulatory Operations. “We look forward to working with FDA to broaden the use of Fentora to opioid tolerant patients with unresolved debilitating breakthrough pain.”

The sNDA includes data from three randomized, placebo-controlled clinical trials and one long-term open-label safety study with a total of 941 opioid tolerant patients. The patients in the trials were treated for as long as 18 months and had a broad range of underlying chronic pain conditions, including chronic low back and chronic neuropathic pain. Opioid-tolerant patients with chronic pain treated with Fentora experienced statistically significant improvements in relief from breakthrough pain with an onset and duration of relief similar to that seen in studies of FENTORA in patients with cancer pain. The FDA’s typical review period for a sNDA is 10 to 12 months.