August 22, 2016
The FDA has approved oxycodone-naltrexone extended-release (ER) capsules (Troxyca ER, Pfizer) 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.
Oxycodone-naltrexone ER has properties that are expected to reduce abuse when crushed and administered by the oral and intranasal routes. However, abuse of oxycodone-naltrexone ER by these routes is still possible. It is the only oxycodone product with oral abuse-deterrent features described in the labeling.
Oxycodone-naltrexone ER capsules contain pellets that consist of oxycodone hydrochloride, an opioid agonist, that surround sequestered naltrexone hydrochloride, an opioid antagonist. When taken as directed, the naltrexone is intended to remain sequestered and patients receive oxycodone in an ER manner.
Studies demonstrated that when the pellets are crushed, the sequestered naltrexone is released and is available to counteract the effects of oxycodone.
The abuse-deterrent features of oxycodone-naltrexone ER were demonstrated in a battery of in vitro laboratory studies and three clinical abuse-potential studies utilizing crushed oxycodone-naltrexone ER by oral and intranasal routes of administration and the intravenous route (with simulated oxycodone-naltrexone ER).
Based on a press release from Pfizer.
