FDA Approves Extended-Release Oxycodone Combo to Deter Abuse

By Chamberlin, Kevin W. | Drug Topics, December 2014 | Go to article overview

FDA Approves Extended-Release Oxycodone Combo to Deter Abuse


Chamberlin, Kevin W., Drug Topics


NEW DRUG REVIEW

An opioid analgesic with an abuse deterrent, the product exhibits properties that can deter, but not entirely prevent, abuse through snorting or injection.

Development of opioids with abuse-deterrent properties is one goal of FDA's campaign against the national epidemic of opioid misuse and abuse. The combination tablet oxycodone hydrochloride and naloxone hydrochloride extended-release (ON-ER) (Targiniq ER; Purdue Pharma) is an opioid agonist and antagonist (2:1 ratio, respectively) approved by FDA on July 23, 2014, for treatment of severe pain. ON-ER is not approved for as-needed pain relief.

As an opioid analgesic with an abuse deterrent, ON-ER exhibits properties that can deter, but not entirely prevent, abuse through snorting or injection.

Efficacy

When crushed or snorted, the naloxone contained in ONER blocks the euphoric effects of oxycodone, making it less attractive to abusers than oxycodone alone. Naloxone has low bioavailability due to extensive first-pass metabolism. This low oral availability reduces any risk of antagonism to the opioid.

ON-ER was administered to 2,396 patients in controlled or open-label clinical studies. One-third (n=794) of the subjects were treated for approximately six months, and 26% (n=621) were treated for approximately one year.

A prospective study of two age groups (19-44 vs. 65-77) assessed age effects of the pharmacokinetics of ON-ER. Compared to younger subjects, elderly subjects showed a higher steady-state oxycodone AUC (18% increase) and higher steady-state naloxone AUC (82% increase). Elderly patients should therefore be monitored more frequently until stable drug effects are achieved.

Safety

Several black-box warning accompany ON-ER, including risk of addiction, abuse, and misuse; serious, life-threatening, or fatal respiratory depression; accidental ingestion by children, resulting in a fatal overdose; neonatal opioid withdrawal syndrome; and fatal overdose concentrations of oxycodone resulting from initiation or discontinuation of CYP3A4 inhibitors.

As with other opioids, the most common adverse reactions with ON-ER were nausea and vomiting. ON-ER, like all opioids, can cause severe hypotension, and concern should be given to patients with reduced blood volume or concurrent administration of certain CNS depressant drugs.

ON-ER is a pregnancy category C. Oxycodone is likely to be present in breast milk; the presence of naloxone is unknown. …

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