Oxycodone DETERx® ER Capsules: A Review in Severe, Chronic Pain.

Abstract

Oxycodone DETERx ® extended-release (ER) capsules (Xtampza® ER), an abuse-deterrent formulation of oxycodone as the myristate salt, are approved in the USA for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. This narrative review discusses the clinical efficacy and tolerability of the oxycodone DETERx ® ER capsule formulation in the management of severe pain, and provides an overview of pharmacokinetics, abuse-deterrent properties and alternative administration options. The microsphere-in-capsule DETERx ® drug delivery platform allows administration via sprinkle-dosing or enteral tubes. The physicochemical properties of the formulation make it difficult to manipulate and its ER pharmacokinetic profile is retained after crushing or chewing. Clinical abuse-potential studies suggest these properties may translate to reduced intranasal abuse, with implications for abuse via the oral route less certain. The efficacy of oxycodone DETERx ® ER in the management of moderate to severe, chronic pain was demonstrated in a well designed, phase III trial, in which it was more effective than placebo at reducing pain intensity. The formulation was generally well tolerated in this trial; the most common treatment-emergent adverse events were nausea and constipation. As an opioid, oxycodone DETERx ® ER carries risks of addiction, abuse and misuse. Post-marketing epidemiological studies will be necessary in determining the impact of oxycodone DETERx ® on oxycodone abuse liability. Nevertheless, oxycodone DETERx ® ER is a useful treatment option for patients with severe, chronic pain, particularly when comorbid dysphagia or difficulty swallowing is a concern.