FDA Advisors Recommend Approval of Oxycodone/ Naltrexone Extended-Release Capsules

Panels support abuse-deterrent labeling for intranasal and IV routes of abuse

The FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and its Drug Safety and Risk Management Advisory Committee have voted 9 to 6 in favor of approval of oxycodone hydrochloride and naltrexone hydrochloride extended-release capsules (ALO-02, 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.

The committees recommended the inclusion of abuse-deterrent labeling for intranasal (11 to 4) and intravenous (9 to 6) routes of abuse. They voted against inclusion of abuse-deterrent labeling for the oral route (6 to 9).

The FDA will consider the committees’ recommendations before acting on the new drug application for ALO-02.

ALO-02 is the first investigational oxycodone formulated with sequestered naltrexone technology designed to help deter oral and nonoral abuse when crushed. ALO-02 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 demonstrate that when the pellets are crushed, up to 100% of the sequestered naltrexone is released and is available to counteract the effects of oxycodone.

Source: Pfizer; June 8, 2016.