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Extended-Release Hydrocodone/ Acetaminophen Combo Shows Efficacy Against Acute Pain

Treatment under FDA review

A phase III efficacy trial of MNK-155 (Mallinckrodt Pharmaceuticals), an investigational extended-release oral formulation of hydrocodone and acetaminophen, has met the study’s primary endpoint of improved pain scores compared with placebo during the first 48 hours following bunionectomy. The difference in pain scores was statistically significant (P < 0.001) in favor of MNK-155.

The new data are being presented at PAINWeek 2014, a national conference on pain for frontline practitioners, held September 2–6 in Las Vegas, Nevada.

MNK-155 is being studied for the management of moderate to moderately severe acute pain where the use of an opioid analgesic is appropriate. The combo treatment is formulated with both immediate- and extended-release components. The release profile of MNK-155 includes Depomed’s Acuform drug delivery technology.

The phase 3 trial was a randomized, double-blind, placebo-controlled, parallel-arm study comparing the efficacy and safety of MNK-155 with that of placebo in 403 patients with moderate to moderately severe acute pain following a unilateral first metatarsal bunionectomy. The patients received a single three-tablet loading dose of MNK-155 (hydrocodone [7.5 mg] and acetaminophen [325 mg] tablets; 22.5 mg/975 mg total dose), followed by two tablets every 12 hours (15 mg/650 mg total dose) over 48 hours or placebo. Rescue ibuprofen (up to 400 mg every 4 hours) was allowed for both the MNK-155 and placebo arms.

The study’s primary endpoint was the summed pain intensity difference (i.e., the change in pain from baseline) over 48 hours (SPID48). Secondary measures included the cumulative SPID at 0 to 4, 0 to 8, 0 to 12, 0 to 24, and 0 to 36 hours; the mean PID beginning 15 minutes after dosing; mean total pain relief (TOTPAR) for the periods 0 to 4, 0 to 8, 0 to 12, 0 to 24, 0 to 36, and 0 to 48 hours; and the time to perceptible, confirmed, and meaningful pain relief.

The most common adverse events associated with the use of MNK-155 included nausea, dizziness, vomiting, headache, constipation, pruritus, and somnolence.

The new drug application for MNK-155 was accepted for review by the FDA in May 2014 and included the results from this study.

Source: Mallinckrodt Pharmaceuticals; September 4, 2014.

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