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Cephalon Presents Positive Results for Fentora in Breakthrough Pain,,,Associated with Neuropathic Conditions

ned to provide early-onset analgesia via a chemical reaction that enhances fentanyl absorption across the inner lining of the cheek. Cephalon is pursuing clinical development of FENTORA in breakthrough pain associated with conditions other than cancer, including chronic neuropathic pain, and expects to file a supplemental New Drug Application this year. FENTORA is not approved for use in these conditions.

The multi-center study evaluated FENTORA in adult patients with chronic neuropathic pain who were diagnosed with a variety of conditions including diabetic peripheral neuropathy, traumatic injury, postherpetic neuralgia and complex regional pain syndrome (CRPS) -- a chronic condition caused by a nerve disorder that occurs at the site of injury, often a fractured arm or leg. All patients were already receiving various around-the-clock opioid medications for persistent pain, and short-acting opioids for their one to four episodes of breakthrough pain a day.

The open label titration phase of the study enrolled 103 patients who were individually titrated to a dose that provided adequate pain relief for at least two of three breakthrough pain flares. Of these, 102 patients received at least 1 dose of FENTORA and 80 patients (78 percent) identified a successful dose with acceptable side effects. Only six patients (6 percent) withdrew from the study due to lack of efficacy. In the randomized, placebo- controlled, double-blind treatment phase in which all patients were exposed to both FENTORA and placebo, data from 75 patients (95 percent of patients who reached a successful dose) were evaluable for efficacy. Key study findings include:


    -- The primary efficacy measure, the Sum of Pain Intensity Differences



       from 5 though 60 minutes (SPID60), demonstrated significantly higher



       scores compared to placebo (9.6 +/- 0.75 vs. 5.7 +/- 0.72, p<0.0001).



    -- Reduction in
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