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www.fdanews.com/articles/72031-cephalon-announces-positive-trial-results-for-oravescent-fentanyl

Cephalon Announces Positive Trial Results for Oravescent Fentanyl

May 6, 2005

Cephalon has announced positive results from its Phase III clinical program with Oravescent fentanyl.

Data from the major efficacy trial showed statistically significant and clinically relevant benefit to patients with breakthrough cancer pain who already were receiving around-the-clock pain- controlling medication for their underlying chronic pain.

The double-blind, placebo-controlled, variable-dose Phase III trial included 123 patients. The primary endpoint was the Sum of Pain Intensity Difference scale. Patients treated with Oravescent fentanyl showed a statistically significant improvement on the primary endpoint. Oravescent fentanyl was generally well-tolerated in this trial.