Oxycodone DETERx®ER Capsules: A Review in Severe, Chronic Pain.
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.
Springer, Private Bag 65901, Mairangi Bay, 0754, Auckland, New Zealand. demail@springer.com.
Yvette N
YN
Lamb
Springer, Private Bag 65901, Mairangi Bay, 0754, Auckland, New Zealand.
Karly P
KP
Garnock-Jones
Springer, Private Bag 65901, Mairangi Bay, 0754, Auckland, New Zealand.
Susan J
SJ
Keam
D000701:Analgesics, Opioid / Q000627:therapeutic use*; D002214:Capsules / Q000627:therapeutic use*; D002626:Chemistry, Pharmaceutical / Q000379:methods; D059350:Chronic Pain / Q000188:drug therapy*; D017326:Clinical Trials, Phase III as Topic; D003692:Delayed-Action Preparations / Q000627:therapeutic use; D006801:Humans; D010098:Oxycodone / Q000627:therapeutic use*
D000701:Analgesics, Opioid; D002214:Capsules; D003692:Delayed-Action Preparations; D010098:Oxycodone