FDA accepts NDA for Pfizer's abuse-deterrent formulation of oxycodone

The FDA has accepted for review Pfizer's NDA for ALO-02 (oxycodone hydrochloride/naltrexone hydrochloride) for the management of pain that requires daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate. ALO-02 contains pellets of an extended-release formulation of the opioid receptor agonistoxycodone hydrochloride surrounding a core of sequesterednaltrexone hydrochloride, an opioid receptor antagonist. When the capsules are taken orally as directed, only the oxycodone is released. However, if the pellets are crushed, the naltrexone is released and this counteracts the effects of oxycodone.

The NDA was based on results from two phase III trials in patients with moderate to severe, noncancer chronic pain (ClinicalTrials.gov Identifiers NCT01571362 andNCT01428583) and three abuse potential studies in recreational opioid users (ClinicalTrials.gov Identifiers NCT01746901NCT01775189 andNCT01825447) (Pfizer News Release; ClinicalTrials.gov Web site).