MNK 155 meets primary endpoint in Phase III Pain study-Mallinckrodt

Mallinckrodt has reported that a Phase III efficacy trial of investigational MNK 155 (hydrocodone + acetaminophen) met the study�s primary endpoint of improved Pain scores vs. placebo over the first 48 hours following bunionectomy. This difference in pain scores was statistically significant in favor of MNK 155. Subjects received a single 3-tablet loading dose of MNK 155 (7.5 mg hydrocodone and 325 mg acetaminophen tablets; 22.5 mg/975 mg total dose), followed by 2 tablets every 12 hours (15 mg /650 mg total dose) over 48 hours or placebo. The primary endpoint was the summed pain intensity difference (change in pain from baseline) over 48 hours (SPID48).

Secondary measures included: Cumulative SPID at 0?4, 0?8, 0?12, 0?24, and 0?36 hours; mean PID beginning 15 minutes after dosing, mean total pain relief (TOTPAR) for the time periods 0?4, 0?8, 0?12, 0?24, 0?36, and 0?48 hours; and time to perceptible, confirmed, and meaningful pain relief. The most common adverse events associated with the use of MNK 155 were nausea, dizziness, vomiting, headaches, constipation, pruritus and somnolence (sleepiness). The data is being presented at PAINWeek 2014.