The efficacy and safety of Onsolis (fentanyl buccal) for the treatment of cancer pain

ABSTRACT Introduction: Fentanyl buccal soluble film (FBSF) uses the newly developed BioErodible MucoAdhesive (BEMA®) drug delivery technology to manage breakthrough pain in opioid-tolerant, adult cancer patients. According to the limited studies available, this formulation of transmucosal fentanyl achieves a high bioavailability and rapid onset of pain relief for episodes of breakthrough cancer pain. Areas covered: The purpose of this article is to review the pharmacokinetics, tolerability and efficacy of FBSF in comparison to other preparations of transmucosal fentanyl. Expert commentary: FBSF seems to be a generally well-tolerated option for the transmucosal delivery of fentanyl in breakthrough cancer pain episodes. Unfortunately, double-blind head-to-head studies comparing FBSF with other opioids for the treatment of breakthrough cancer pain are missing. Hence, many important questions remain unanswered and need to be addressed in the future by clinically meaningful independent studies. These should include studies about clinically relevant differences between rapid onset opioids with regard to tolerability, efficacy, safety, cost-effectiveness and potential for dependency and misuse.