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EudraCT: 2010-021602-37; NCT01663116; Results.

Background: Fentanyl buccal soluble film (FBSF) has been developed as a treatment of breakthrough pain in opioid-tolerant patients with cancer. The objective of this study was to evaluate the efficacy of FBSF at doses of 200–1200 μg in the management of breakthrough pain in patients with cancer receiving ongoing opioid therapy.Patients and methods: This was a multicenter, randomized, double-blind, placebo-controlled, multiple-crossover study that included opioid-tolerant adult patients with chronic cancer pain who experienced one to four daily episodes of breakthrough pain. The primary efficacy assessment was the sum of pain intensity differences at 30 min (SPID30) postdose.Results: The intent-to-treat population consisted of 80 patients with ≥1 post-baseline efficacy assessment. The least-squares mean (LSM ± SEM) of the SPID30 was significantly greater for FBSF-treated episodes of breakthrough pain than for placebo-treated episodes (47.9 ± 3.9 versus 38.1 ± 4.3; P = 0.004). There was statistical separation from placebo starting at 15 min up through 60 min (last time point assessed). There were no unexpected adverse events (AEs) or clinically significant safety findings.Conclusions: FBSF is an effective option for control of breakthrough pain in patients receiving ongoing opioid therapy. In this study, FBSF was well tolerated in the oral cavity, with no reports of treatment-related oral AEs.

BackgroundFistulas may arise as a relevant complication of Crohn’s disease (CD). Despite their clinical significance and the substantial burden imposed on patients, limited data are available on the epidemiology of fistulizing CD in the United States.MethodsA systematic literature review was conducted to identify data published between 1970 and 2017 on the epidemiology of fistulas in patients with CD, with the aim to estimate the number of prevalent cases in the United States. Retrieved titles and abstracts were screened by 2 independent researchers for inclusion criteria (US population-based studies reporting data on the epidemiology of fistulizing CD). To validate the literature-based estimate, data from a US claims database (Truven Health MarketScan database) were analyzed. This database has broad geographic coverage, with health care data for >60 million patients during the period of the analysis.ResultsThe literature search retrieved 7 articles for full-text review, and only 1 met the criteria for inclusion. This study described the cumulative incidence of fistulas in a CD population from Minnesota over 20 years. From the reported data, the estimated number of prevalent cases with fistulizing CD in the United States was ~76,600 in 2017 (~52,900 anal, ~7400 rectovaginal, ~2300 enterocutaneous, and ~14,100 internal). Analysis from the US health care database resulted in an estimated number of ~75,700 patients, confirming the robustness of the original estimate from the literature.ConclusionsBased on 2 separate analyses, the estimated number of patients with fistulizing CD in the United States is ~77,000 patients.

All three FBSF formulations produced greater peak plasma concentrations and overall exposure to fentanyl than OTFC. In particular, the pH 7.25 FBSF formulation showed the most favourable pharmacokinetic profile of the three FBSF formulations. In comparison with OTFC, the pH 7.25 FBSF formulation produced the fastest and most efficient fentanyl delivery and was selected for further clinical development.

Introduction: Despite the fact that perianal fistulas are associated with significant morbidity and impaired quality of life, their prevalence in Europe is unknown. The aim of this study was to estimate the prevalence of perianal fistulas in Europe, overall and according to etiology. Methods: Two independent literature reviews were performed using different search strategies to maximize the identification of potentially relevant studies. Data from relevant articles were used to estimate the prevalence of perianal fistulas in Europe. The robustness of the estimate was evaluated using data from a large population-based database from the UK. Results: A total of 26 studies provided epidemiological data on perianal fistulas, of which 16 provided suitable data to estimate the prevalence. Estimations using these data yielded a total prevalence of 1.69 per 10,000 population. Cryptoglandular infection and Crohn's disease (CD) were the predominant etiologies, with prevalence rates at 0.86 and 0.76 per 10,000 population, respectively. Comparison of prevalence data from the UK population-based database with the European population resulted Enhanced Digital Features To view enhanced digital features for this article go to https://doi.org/10.6084/ m9.figshare.9948788.

ObjectiveThe objectives of the study were to determine the absolute bioavailability of fentanyl from fentanyl buccal soluble film, estimate the percentage of a fentanyl dose absorbed through the buccal mucosa, and compare the bioavailability of equivalent doses administered either as single or multiple dose units.DesignOpen-label, randomized, four-period, Latin-square crossover pharmacokinetic study.SettingInpatient phase 1 unit.PatientsTwelve healthy volunteers.InterventionsInjectable fentanyl citrate (200 µg) administered by intravenous infusion, injectable fentanyl citrate (800 µg/16 mL) administered orally, and fentanyl buccal soluble film (800 µg) administered as a single film and as four separate 200 µg films simultaneously.Outcome MeasuresPlasma concentrations after fentanyl dosing; pharmacokinetic parameters.ResultsThe two buccal film treatments were bioequivalent and both had an absolute bioavailability of 71%. The percentage of an administered dose absorbed through the buccal mucosa was calculated to be 51%.ConclusionsFentanyl buccal soluble film effectively delivers a high percentage of the administered fentanyl dose and nearly identical plasma profiles are obtained when equivalent doses are delivered by single or multiple dosage units.

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