Fentanyl buccal tablets for the treatment of breakthrough pain.

SUMMARY Fentanyl buccal tablets (FBT) have been designed to treat breakthrough pain (BTP) in patients who are already receiving, and who are tolerant to, opioid therapy for their underlying persistent pain. FBT are a formulation that uses an effervescent drug delivery system to enhance penetration across the buccal mucosa. OraVescent technology provides an effervescent reaction that liberates carbon dioxide in the buccal cavity. This reaction causes an initial decrease in pH, which facilitates solubilization, thus driving fentanyl into solution. Subsequently, carbon dioxide increases the local pH, which facilitates permeation of unionised fentanyl across the buccal mucosa. In clinical studies of opioid-tolerant patients with cancer and noncancer-related BTP, FBT have provided consistent and clinically relevant improvements in pain intensity and pain relief relative to placebo and oral opioids like oxycodone. The safety and tolerability profile is generally typical of that observed with other opioids. The pharmacokinetic properties of FBT allow for a meaningful clinical efficacy, with an onset of action that closely matches the onset of BTP. FBT, as with any other transmucosal preparations of fentanyl, should not be used in patients who are not opioid-tolerant.