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Cancer-related breakthrough pain (BTP) is typically managed with a short-acting oral opioid, taken as needed during a fixed-schedule opioid regimen. The conventional approach may not provide the onset of analgesia required for BTP for many patients, because the onset of analgesia with short-acting opioids lags behind the time course of the majority of episodes of BTP. The fentanyl buccal tablet (FBT) employs a novel delivery system that enhances the rate and extent of absorption of fentanyl through the buccal mucosa. This double-blind, randomized, placebo-controlled study evaluated the efficacy, safety, and tolerability of FBT in opioid-treated patients with cancer-related BTP.After an open-label titration (N=123) to identify an effective FBT dose to treat BTP episodes, 77 patients were randomly assigned to 1 of 18 prespecified dose sequences of 10 tablets (7 FBT and 3 placebo). Pain intensity, pain relief (PR), and global performance of the medication were recorded at regular time intervals between 15 and 60 minutes. Pain intensity differences (PID), the summed PID (SPID), and summed total PR were calculated. The SPID at 30 minutes (SPID30) was the primary efficacy variable. Adverse events were reported.Sixty-five percent (80/123) of patients were titrated to an effective dose. The mean (SE) SPID30 for FBT was 3.0±0.12 versus 1.8±0.18 for placebo (P<0.0001). Measures of PR, PID, SPID, summed total PR, and patient ratings of global performance of medication significantly favored FBT over placebo at all time points. Adverse events were typical of opioid drugs. Poor oral tolerability was noted in 2 patients.FBT is efficacious and safe in the treatment of cancer-related BTP.