Finding an effective dose of fentanyl effervescent buccal tablets: Combined results of open-label titration

Abstract

18521 Background: Standard recommendations for short-acting oral opioid doses to manage breakthrough pain (BTP) assume some relation with the stable opioid dose used to treat persistent pain. Fentanyl effervescent buccal tablets (FEBT) are designed to enhance the efficiency of fentanyl absorption through the buccal mucosa. They may provide rapid-onset analgesia. This pooled analysis of data from 3 studies examined the relationship between effective FEBT dose and around-the-clock (ATC) dose in patients who completed open-label titration to an effective FEBT dose. Methods: Patients were 18–80 years of age with cancer, persistent pain, and BTP. Eligible patients experienced an average of 1–4 episodes of BTP per day and were receiving stable doses of opioids (≥60 mg/day of morphine or equivalent) for persistent pain. Titration guidelines were uniform across studies; the maximum allowed dose of FEBT was 800 μg. Results: Of 304 patients enrolled, 208 completed titration to an effective FEBT dose; of these, 100 μg was effective in 21 patients, 200 μg in 32, 400 μg in 45, 600 μg in 49, and 800 μg in 61. The effective dose of FEBT showed no relationship to the dose of either ATC or supplemental opioids. No correlation was found between the effective dose of FEBT and the average dose of prior supplemental opioids (r2 = .0322; Pearson’s coefficient = .1793), the effective dose of FEBT and the dose of ATC opioids in patients using oral ATC opioids (r2 = .0353; Pearson’s coefficient = .1878), or the effective dose of FEBT and the dose of ATC opioids in patients using transdermal fentanyl alone or in combination with other opioids as ATC medication (r2 = .0289; Pearson’s coefficient = .1701). Conclusions: No predictable relationship between the effective dose of FEBT and the dose of ATC opioids was observed. Titration will allow the identification of each patient’s effective dose of FEBT for relief of BTP. [Table: see text]