US drugmaker Cephalon says that data from a Phase III trial shows that its drug Fentora (fentanyl buccal tablet) is beneficial for the treatment of breakthrough pain in patients already receiving opioid-based treatment for neuropathic pain. The findings, which were announced at the annual meeting of the American Academy of Neurology in Boston, are from a study that examined the drug in adult patients suffering pain associated with conditions ranging from diabetic neuropathy to traumatic injury.
The results showed that, in terms of the primary efficacy measure, the sum of pain intensity differences from five to 60 minutes, Fentara brought about significantly higher scores compared with placebo (9.6 versus 5.7). In addition, treatment achieved a greater reduction in pain intensity and use of opioid-based relief than placebo throughout the 120-minute observation period. The firm expects to file a New Drug Application later this year.
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