The US Food and Drug Administration (FDA) Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee voted (9 to 6) in favor of approval of Pfizer's ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride) extended-release capsules for its proposed indication, “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 take the Committees’ recommendations into consideration before taking action on the New Drug Application for ALO-02.
“Pfizer believes the ALO-02 data support approval with abuse-deterrent labeling and we look forward to ongoing discussions with the FDA,” said Ken Verburg, PhD, chief development officer, neuroscience and pain, Pfizer Inc. “Abuse-deterrent opioids are an important part of a multi-faceted approach to help address the growing abuse epidemic.”
ALO-02 is the first investigational oxycodone formulated with sequestered naltrexone technology designed to help deter oral and non-oral 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 per cent of the sequestered naltrexone is released and is available to counteract the effects of oxycodone.