A dose titration study of fentanyl buccal soluble film for breakthrough cancer pain in Taiwan.

ABSTRACT:

Background

Fentanyl buccal soluble film (FBSF), a new formulation of fentanyl, is developed for the treatment of breakthrough pain (BTP) in opioid-tolerant patients with cancer.

Aims

This study aimed to assess the feasible dose range of FBSF required for Taiwanese population.

Methods and results

This was an open-label, multicenter, noncomparative study. Cancer patients who were aged 20 years or older and had a stable regimen equivalent to 60 to 1000 mg/day of oral morphine, 20 to 120 mg/day of intravenous morphine, or 25 to 300 μg/h of transdermal fentanyl for at least 1 week were enrolled. The primary endpoint was the feasible dose range of FBSF. Secondary endpoints included difference in pain intensity at 30 minutes (PID30), percentage of episodes requiring rescue m

SUBMITTER: Chiou TJ 

PROVIDER: S-EPMC7941537 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature