FDA Approves Abuse-Deterrent, Extended-Release Oxycodone / Naltrexone (Troxyca ER) for Pain Management

Capsules are designed to reduce abuse when crushed and taken by oral and IV routes

The FDA has given the nod to Troxyca ER (oxycodone hydrochloride and naltrexone hydrochloride, Pfizer) extended-release capsules for oral use (CII) 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.

Troxyca ER has properties that are expected to reduce abuse when crushed and administered by the oral and intranasal routes. However, abuse of Troxyca ER by these routes is still possible. It is the only oxycodone with oral abuse-deterrent features described in the labelling, according to Pfizer.

Troxyca ER extended-release capsules contain pellets that consist of oxycodone hydrochloride, an opioid agonist, which surround sequestered naltrexone hydrochloride, an opioid antagonist. When taken as directed, the naltrexone is intended to remain sequestered, and patients receive oxycodone in an extended-release manner. Studies have shown 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 Troxyca ER were demonstrated in a battery of in vitro laboratory studies and in three clinical abuse-potential studies using crushed Troxyca ER by oral and intranasal routes of administration and the intravenous route (with simulated Troxyca ER).

Troxyca ER is contraindicated in patients with:

  • Significant respiratory depression
  • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
  • Known or suspected gastrointestinal obstruction, including paralytic ileus
  • Hypersensitivity (e.g., anaphylaxis) to oxycodone or naltrexone or any other components of the Troxyca ER formulation

Source: Pfizer; August 19, 2016.