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news.Cephalon has reported positive results from a 12-week Phase III clinical trial of Fentora in patients with breakthrough pain associated with a broad range of chronic non-cancer pain conditions.
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The study achieved statistical significance on the primary endpoint. Results across the 12 weeks of treatment showed both statistically significant and clinically relevant outcomes for patients with breakthrough pain who were already receiving and who were tolerant to opioid therapy for their underlying persistent pain.
Fentora is approved only 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.
“These data show similar positive outcomes as those with Fentora in treating breakthrough pain in opioid-tolerant patients with cancer, chronic neuropathic pain, and chronic low-back pain,” said Dr Lesley Russell, executive vice president of worldwide medical and regulatory operations. “We plan to submit these data to the FDA in the fourth quarter as part of our supplemental new drug application.”
The double-blind, placebo-controlled, variable dose Phase III trial included 148 patients. The primary endpoint was 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 over the first 60 minutes after treatment.
Cephalon said that patients treated with Fentora showed a statistically significant improvement on the primary endpoint compared with placebo. The drug was generally well tolerated by the study participants, with side effects consistent with those in the currently approved label. The company plans to present the data at a major medical meeting in the future.