(429) Randomized, double-blind, placebo-controlled, phase 3 study of the safety and analgesic efficacy of MNK-155 extended-release hydrocodone bitartrate/acetaminophen tablets (HB/APAP ER) in an acute pain model

A Review of the Literature on Multiple Factors Involved in Postoperative Pain Course and Duration

“…12,58,60 Two similar fixed-dose combination products, ER oxycodone/acetaminophen and ER hydrocodone bitartrate/acetaminophen, have a dual-layer biphasic formulation that delivers a portion of the dose immediately and the remainder slowly over a 12-hour dosing interval. In phase 3 randomized, double-blind, placebo-controlled trials, ER oxycodone/acetaminophen 15 mg/650 mg 66 and ER hydrocodone bitartrate/acetaminophen 15 mg/650 mg 67 were associated with significantly greater reductions in pain intensity over 48 hours compared with placebo in patients who had undergone unilateral bunionectomy. Clinically meaningful pain relief was observed within 30 to 60 minutes in both studies.…”

“…5,58 The efficacy and safety of postoperative analgesia using ER opioids have been studied in randomized, placebo-controlled clinical trials of only 4 ER opioids: ER oxymorphone, 63 CR oxycodone, 64,65 ER oxycodone/acetaminophen, 66 and ER hydrocodone bitartrate/acetaminophen. 67 In a 2004 study, ER oxymorphone provided significant improvements in 126 patients with moderate or severe pain 12 hours after knee arthroplasty; however, the onset of meaningful pain relief was only noted 3 hours after administration, and the manufacturer did not pursue additional trials for acute pain. 63 Oral CR oxycodone (10 mg administered 30 minutes before entering the operating room and every 12 hours thereafter) plus IV acetaminophen (1 g administered every 6 hours after entering the operating room) was as effective as a continuous infusion (7 mL/h) of levobupivacaine (0.125%) with sufentanil (0.7 µg/mL) in providing postoperative analgesia over 3 days in 270 patients who had undergone total hip replacement.…”

“…Clinically meaningful pain relief was observed within 30 to 60 minutes in both studies. 66,67 Extended-release oxycodone/acetaminophen has been approved for the management of acute pain severe enough to require opioid treatment and for which alternative treatment options are inadequate. 68 …”