Pfizer announced that the Food and Drug Administration (FDA) Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee voted to recommend approval of ALO-02 (oxycodone HCl and naltrexone HCl) 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.
The Committees voted 11-4 recommending the inclusion of abuse-deterrent labeling for the intranasal route of abuse and voted 9-6 for the intravenous route of abuse. However, they voted against the inclusion of abuse-deterrent labeling for the oral route (6-9). In the briefing document, it was noted that the abuse deterrent properties of ALO-02 were tested in many solvents and conditions. In these studies, there were some potential vulnerabilities identified that could form the basis for potential methods to prepare ALO-02 for oral abuse. These potential vulnerabilities depended on the solvent, the condition, and the time. The brief windows of opportunity differed from solvent to solvent and from condition to condition, with respect to the timing of onset of potential vulnerability.
ALO-02 is an investigational oxycodone formulated with the same sequestered naltrexone technology as seen in Embeda (morphine sulfate and naltrexone HCl), which is intended to help deter oral and non-oral routes of abuse when crushed. The extended-release capsules contain pellets of oxycodone HCl, an opioid agonist, that surround the naltrexone HCl, an opioid antagonist. When ingested, the naltrexone remains sequestered and patients receive the oxycodone in an extended-release period. When the pellets are crushed, up to 100% of the sequestered naltrexone is released and serves to counteract the effects of oxycodone.
The FDA is not bound by the Committees’ recommendation but will take into consideration before taking action on the New Drug Application for ALO-02.
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