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| |  Fentanyl Buccal Bests Immediate-Release Oxycodone for Breakthrough Pain Relief: Presented at AAPM By Jennifer Reising SAN ANTONIO, Tex -- February 5, 2010 -- Among patients with chronic pain, onset of analgaesia for breakthrough pain (BTP) is faster with oral fentanyl buccal, compared with immediate-release oxycodone, according to a study presented here at the 26th annual meeting of the American Academy of Pain Medicine (AAPM). The head-to-head study included 323 adults who had 1 to 4 episodes of BTP per day, each lasting <4 hours. Patients were achieving at least partial relief with opioids and had an average pain intensity (PI) score of <=6 on a 10-point scale. The crossover study included 2, randomised, open-label titration periods and 2, randomised, double-blind, double-dummy treatment periods. After fentanyl buccal and immediate-release oxycodone were titrated to a successful dose, patients were treated for 10 BTP episodes with 1 study drug and the next 10 episodes with the other drug. Patients rated BTP PI pre-dose and 5 to 60 minutes post-dose. The primary endpoint was mean PI difference (PID) 15 minutes post-dose. Secondary endpoints included PID 5 to 60 minutes post-dose, pain relief (0-4 scale) 5 to 60 minutes post-dose, and medication performance assessment (MPA) at 30 and 60 minutes. Mean PID was significantly greater with fentanyl buccal at 15 minutes, compared with oxycodone (0.82 vs 0.59; P < .0001). This improvement was documented during all other time points assessed (5-60 min; P < .01). Pain relief was significantly greater following fentanyl buccal administration, versus oxycodone administration, at 10 minutes (0.30 vs 0.25; P < .05) and at all points measured from 10 to 60 minutes (P < .05). MPA was also significantly better with fentanyl buccal at 30 and 60 minutes, compared with oxycodone (P < .0001). Of the 320 patients who entered the titration stage, 162 (51%) reported adverse events (AEs), which were similar between the 2 treatment groups. No serious treatment-related AEs occurred. “Our study shows that the efficacy of fentanyl buccal tablet is earlier than immediate-release oxycodone,” said John Messina, PharmD, Cephalon, Inc., Frazer, Pennsylvania, on February 4. “Patients also rated the effectiveness of the medication superior to oxycodone.” Funding for this study was provided by Cephalon, Inc. [Presentation title: Efficacy and Safety of Fentanyl Buccal Tablet Compared With Oxycodone Immediate-Release for the Management of Breakthrough Pain in Opioid-Tolerant Patients With Chronic Pain. Abstract 185]
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