Cephalon, Inc. (Nasdaq:CEPH) recently announced the postive results of its Phase 3 clinical trial of FENTORA™ (fentanyl buccal tablet) [C-II], demonstrating efficacy in the management of breakthrough pain in opioid-tolerant patients with chronic low back pain.
The double-blind placebo controlled study revealed apparent statistically significant differences in pain intensity within 10 minutes (p<0.02) and at all subsequent time points measured throughout the 120 minute assessment period (p<0.0001).
Cephalon, Inc.'s FENTORA™ was approved by the USFDA last September 25, 2006, 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.
According to Dr. Lesley Russell, Cephalon, Inc.'s Senior Vice President, Worldwide Medical and Regulatory Operations:
"The results of this study suggest that FENTORA may have application beyond its current indication in cancer and provide important support to our strategy for future label expansion in breakthrough pain associated with multiple chronic pain conditions.
In opioid-tolerant patients, we believe FENTORA has the potential to address the rapid onset characteristic of breakthrough pain, a common component of low back pain."
As reported by the American Chronic Pain Association, an estimated 51 percent of people with chronic pain report back pain, thereby making low back pain the most common chronic pain condition.
Find more details of the FENTORA™ Phase 3 Clinical Trial at Cephalon, Inc.'s press release.
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