Pfizer Gets FDA Approval for Abuse-Deterrent Opioid
Pfizer has received approval from the US Food and Drug Administration (FDA) for an abuse-deterrent version of oxycodone, Troxyca ER (oxycodone hydrochloride and naltrexone hydrochloride) extended-release capsules, 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 oral and intranasal routes.
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 demonstrated that when the pellets are crushed, the sequestered naltrexone is released and is available to counteract the effects of oxycodone.