Safety and tolerability of IR/ER OC/APAP are similar to other low-dose opioid/APAP analgesics.

This phase 1 study conducted in the United States was not registered.

OC/APAP ER was efficacious and generally well tolerated in an established model of moderate to severe acute pain, providing an onset of analgesia in approximately 30 minutes and sustained pain relief over the 12 hour dosing period.

Immediate-release/extended-release oxycodone/acetaminophen produced lower oxycodone C and longer t than immediate-release oxycodone/acetaminophen. Lower oxycodone concentrations, particularly at earlier time points, were strongly correlated with lesser positive subjective drug effects.

These results show that ER OC/APAP demonstrated an expected safety and tolerability profile and good patient satisfaction in a postsurgical model of acute pain.