FDA Approves Extended-Release Hydrocodone with Abuse-Deterrent Properties

Within months of one federal agency releasing opioid guidelines that include a recommendation against extended-release/long-acting (ER/LA) opioids, another federal agency has approved a new ER/LA opioid marketed as the first to contain abuse-deterrent properties.

In August of this year, the FDA approved Troxyca ER (oxycodone hydrochloride and naltrexone hydrochloride) extended-release capsules for oral use "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," according to a press release from the manufacturer, Pfizer Inc, on its website.1

Pfizer says Troxyca ER has properties that are expected to reduce abuse when crushed and administered by the oral and intranasal routes, and that it is "the only oxycodone with oral abuse-deterrent features described in the labeling."1

However, the company writes, abuse of Troxyca ER by oral and intranasal routes is still possible.

According to Pfizer, the 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 while patients receive oxycodone in an extended-release manner. Pfizer reported that studies demonstrated that when the pellets are crushed, the sequestered naltrexone is released and is available to counteract the effects of oxycodone.

Five months before the release of Troxyca ER, in March 2016, the US Centers for Disease Control and Prevention (CDC) released its Guideline for Prescribing Opioids for Chronic Pain. The guideline included a recommendation against the use of ER/LA opioids.

The CDC guideline says, under Opioid Selection, Dosage, Duration, Follow-Up, and Discontinuation: "When starting opioid therapy for chronic pain, clinicians should prescribe immediate-release opioids instead of extended-release/long-acting (ER/LA) opioids."2

The FDA has faced criticism over the past 2 years for approving new and potentially dangerous ER/LA opioids at a time when prescription opioid abuse is still an out-of-control problem. The Pfizer release claims that its new formula addresses the need for deterring abuse while making available an extended hydrocodone capsule for severe pain.

"Public health authorities and regulators have encouraged the development of treatments that are more difficult to abuse, yet offer pain relief to appropriate patients when used as indicated," said Rory O'Connor, MD, Pfizer's Chief Medical Officer for Internal Medicine, in the press release. "The development of this medication with abuse-deterrent properties is another example of our ongoing commitment to advancing science and the treatment of patients with pain conditions."1

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