Oral transmucosal fentanyl citrate (OTFC); Actiq) is a drug delivery formulation used for management of breakthrough cancer pain. Previous studies with open-label comparisons indicated OTFC was more effective than patients' usual opioid for breakthrough pain. The objective of this study was to compare OTFC and morphine sulfate immediate release (MSIR) for management of breakthrough pain in patients receiving a fixed scheduled opioid regimen. This double-blind, double-dummy, randomized, multiple crossover study was conducted at 19 US university- and community-based hospitals and clinics and comprised 134 adult ambulatory cancer patients. Patients were receiving a fixed scheduled opioid regimen equivalent to 60-1000 mg/day oral morphine or 50-300 microg/h transdermal fentanyl, were using a 'successful' MSIR dose (15-60 mg) as defined by entry criteria, and were experiencing 1-4 episodes of breakthrough pain per day. In open-label fashion, OTFC was titrated such that a single unit (200-1600 microg) provided adequate pain relief with acceptable side effects. Successfully titrated patients entered the double-blind phase of the study and received ten prenumbered sets of randomized capsules and oral transmucosal units. Five sets were the successful OTFC dose paired with placebo capsules, and five sets were placebo OTFC paired with capsules containing the successful MSIR dose. Patients took one set of study medication for each episode of target breakthrough pain. Pain intensity (PI), pain relief (PR) and global performance of medication (GP) scores were recorded. Pain intensity differences (PID) were calculated and 15-min PID was the primary efficacy variable. Adverse events were recorded. Sixty-nine percent of patients (93/134) found a successful dose of OTFC. OTFC yielded outcomes (PI, PID, and PR) at all time points that were significantly better than MSIR. GP also favored OTFC and more patients opted to continue with OTFC than MSIR following the study. Somnolence, nausea, constipation, and dizziness were the most common drug-associated side effects. In conclusion, OTFC was more effective than MSIR in treating breakthrough cancer pain.

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e19567 Background: Breakthrough pain in cancer (BTPc) involves intermittent episodes of intense pain of limited duration. Prevalence estimates range from 19% to 95% in patients with cancer.Little information is available on how the effectiveness of treatments for BTPc may be affected by patient level of function. Methods: This is a post hoc analysis of data from an open-label, long-term safety study that used fentanyl pectin nasal spray (FPNS, Lazanda, PecFent) for BTPc in patients with ECOG score ≤2. The study included patients who experienced BTPc in spite of background pain that was adequately controlled with at least 60 mg of morphine (or equivalent). Dose of FPNS (100 to 800 mcg) was established during a titration period prior to the open-label phase of the study. The study included assessment of acceptability of FPNS through a 3-question, 4-point scale survey (not satisfied-very satisfied) for ease of use, convenience, and reliability. This analysis assessed acceptability scores grouped by ECOG score after the first 4 weeks of open-label use. Results: There were 195 patients for whom information on baseline ECOG scores and acceptability scores after 4 weeks were reported. For all patients, the ease of use, convenience, and reliability of FPNS were reported as satisfied or very satisfied: 97.4%, 96.9%, and 92.3%, respectively. When sub-grouped by ECOG 0 (n=20), 1 (n=130), and 2 (n=45), results were: ease of use, 100%, 97.7%, 95.6%; convenience, 100%, 96.9%, 95.6%; reliability, 100%, 92.3%, 88.9%, respectively. The percentage of patients who were satisfied or very satisfied with treatment was always high, but increased with level of function, ranging from 88.9% to 95.6% of patients with ECOG score of 2, to 100% of patients with ECOG score of 0. Conclusions: FPNS was well accepted for the treatment of BTPc in patients irrespective of ECOG score (0-2). Overall, more than 90% of patients reported being satisfied or very satisfied with the ease of use, convenience, and reliability of treatment. Patients with lower ECOG scores had slightly higher acceptability scores. Future BTPc studies examining subjective scores should consider differences in ECOG status.

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