Kosugi, T., Hamada, S., Takigawa, C., Shinozaki, K., Kunikane, H., Goto, F., . . . Eguchi, K. (2014). A randomized, double-blind, placebo-controlled study of fentanyl buccal tablets for breakthrough pain: Efficacy and safety in Japanese cancer patients. Journal of Pain and Symptom Management, 47, 990–1000.
To examine the efficacy and safety of fentanyl buccal tablets (FBT) for treating breakthrough pain in patients with cancer
A dose titration of FBT was administered a maximum of four times. If ineffective, FBT was titrated to the next dose. In this double-blind study, nine tablets were prescribed, six being BTP and three a placebo. One tablet was taken per episode of breakthrough pain.
Double-blinded, placebo-controlled study
A significant difference was observed between the treatment groups and the primary endpoint. The mean was 2.4 for FBT treatment and 2 for the placebo. Regarding the effectiveness of FBT in the questioner survey, 22 and 56 subjects responded that analgesic onset of FBT occurred within 15 or within 15–30 minutes postadministraion.
In this study, FBT was well-tolerated in patients with cancer and was shown to relieve breakthrough pain in patients receiving around-the-clock opioids.
FBT may be useful in cancer-related breakthrough pain with around-the-clock dosing of opioids.