FDA Accepts Pfizer’s NDA for Abuse-Deterrent Opioid
Pfizer Inc. reports that the US Food and Drug Administration (FDA) has accepted for review the new drug application (NDA) for ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride), extended-release capsules, an abuse-deterrent formulation (ADF) opioid. ALO-02 is an extended-release oxycodone specifically designed to reduce abuse via the oral, intranasal (i.e., snorting) and intravenous (IV) routes when crushed.
ALO-02 capsules contain pellets that consist of extended-release oxycodone hydrochloride, an opioid agonist, which surround sequestered naltrexone hydrochloride, an opioid receptor antagonist. When used as directed, the naltrexone remains sequestered and patients receive oxycodone in an extended release manner. When the pellets are crushed in an attempt to misuse or abuse ALO-02, naltrexone is released and is designed to counteract the effects of oxycodone.
In its NDA, Pfizer is seeking approval of ALO-02 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. If approved, ALO-02 would become Pfizer's second abuse deterrent formulation opioid.