Cephalon Reports Results From Fentora Study

Cephalon announced positive results from a 12-week, Phase III clinical trial of Fentora in patients with breakthrough pain associated with a broad range of chronic noncancer conditions.

The 148-patient, double-blind, placebo-controlled, variable dose Phase III trial had a primary endpoint of the sum of pain intensity differences from five to 60 minutes (SPID(60)), as assessed after 12 weeks of treatment. SPID(60) is a measure that assesses analgesic efficacy of a pain medication in the first 60 minutes after treatment, Cephalon said.

According to the company, patients treated with Fentora showed a statistically significant improvement on the primary endpoint compared with placebo.