Dose Proportionality and Pharmacokinetics of Fentanyl Buccal Soluble Film in Healthy Subjects : A Phase I, Open-Label, Three-Period, Crossover Study.

Background And Objectives: Fentanyl buccal soluble film (FBSF) is a small, bilayered, water-soluble polymer film (BioErodible MucoAdhesive; BEMA™) that adheres to the buccal mucosa and rapidly delivers fentanyl into the systemic circulation. It is approved for the treatment of cancer breakthrough pain in adult opioid-tolerant patients. The objective of this study was to evaluate the dose proportionality of the pharmacokinetics of FBSF in healthy subjects across a range of doses.

Dose proportionality and pharmacokinetics of fentanyl buccal soluble film in healthy subjects: a phase I, open-label, three-period, crossover study.

Background And Objectives: Fentanyl buccal soluble film (FBSF) is a small, bilayered, water-soluble polymer film (BioErodible MucoAdhesive; BEMA™) that adheres to the buccal mucosa and rapidly delivers fentanyl into the systemic circulation. It is approved for the treatment of cancer breakthrough pain in adult opioid-tolerant patients. The objective of this study was to evaluate the dose proportionality of the pharmacokinetics of FBSF in healthy subjects across a range of doses.

Safety and tolerability of combination acyclovir 5% and hydrocortisone 1% cream in adolescents with recurrent herpes simplex labialis.

A Phase 3, open-label, multicenter study was conducted to assess the safety of the combination of 5% acyclovir and 1% hydrocortisone cream (AHC cream) in the treatment of recurrent herpes simplex labialis (HSL) in immunocompetent adolescents. Eligible subjects were aged 12 to 17 years and had a history of recurrent labial herpes with two or more episodes during the last 12 months. Subjects initiated treatment at the first signs or symptoms of a herpes recurrence-at the earliest prodromal phase and preferably before the presence of papules or vesicles.

Absorption and tolerability of fentanyl buccal soluble film (FBSF) in patients with cancer in the presence of oral mucositis.

Purpose: Fentanyl buccal soluble film (FBSF) consists of a small, bilayered, water-soluble polymer film that adheres to the buccal mucosa and rapidly delivers fentanyl into the systemic circulation. The purpose of this study was to evaluate the absorption of fentanyl from FBSF in patients with cancer, with and without grade 1 oral mucositis, and to assess the tolerability of FBSF in this patient population.

Patients And Methods: In an open-label, single-dose study, two groups of opioid-naive patients (ie, not receiving opioids on a regular basis) with cancer received a 200 μg dose of FBSF.