Fentanyl buccal tablet for the treatment of cancer-related breakthrough pain

Abstract

Fentanyl buccal tablet (FBT) (FENTORA) is indicated for the management of breakthrough pain (BTP) in patients with cancer pain and who are tolerant to ≥60 mg of oral morphine equivalents, at least with the current availability of the minimal strength of 100 μg. FBT uses the OraVescent technology to further increase the rate and extent of absorption of fentanyl. Short-term, randomized, controlled, clinical studies of FBT in patients with cancer pain have shown the efficacy of FBT in the management of breakthrough cancer pain. The efficacy was also confirmed in long-term studies on the safety and tolerability of FBT. It has been recommended that administration should be tailored to the patient’s individual requirement, through dose titration starting from the lowest dose to find the effective dose. However, recent studies have demonstrated that predictable doses calculated from the basal opioid regimen are safe and more effective than doses achieved after dose titration.

Keywords:

• breakthrough cancer pain
• cancer pain
• fentanyl buccal tablet
• opioids

Financial & competing interests disclosure

The author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

No writing assistance was utilized in the production of this manuscript.

Key issues

• Fentanyl buccal tablet (FBT) produces rapid analgesia in patients with FBT. Randomized, double-blind studies have shown that FBT is more effective than placebo and oral opioids.

• The use of FBT is relatively safe, as most adverse effects reported are those commonly reported with the chronic opioid treatment. Long-term studies provided further data about the efficacy and safety of FBT.

• The choice of the dose to be used remains controversial. It seems that doses proportional to the basal opioid regimen may provide a better analgesia and a similar safety in comparison with the dose found after dose titration, which may reduce the patient’s compliance.