The first study involved 75 patients in a variety of chronic conditions associated with neuropathic pain and demonstrated a statistically significant improvement in pain compared to placebo as early as 10 minutes. Previous studies submitted to the FDA only began evaluating pain relief at 15 minutes. The medication was generally well tolerated with adverse events typical of opioids.
Similar results were reported for a second double-blind, placebo-controlled study that evaluated the onset of pain relief with Fentora in 78 opioid-tolerant patients with cancer. Fentora is currently only approved by the FDA for the management of breakthrough pain in patients with cancer.
“These new studies of Fentora provide strong support for our clinical development strategy in breakthrough pain in additional chronic pain conditions,” said Dr Lesley Russell, executive vice president of Worldwide Medical and Regulatory Operations. “These data further suggest that, in opioid-tolerant patients, the onset of pain relief from Fentora may be more rapid than indicated in the approved labeling.”
Cephalon expects to seek regulatory approval for an expansion of the labeled indications for Fentora, which will include data from phase III studies in patients with chronic pain conditions associated with breakthrough pain, such as neuropathic and low back pain.