Mallinckrodt Pharmaceutical’s MNK-155, an Extended-Release Hydrocodone/Acetaminophen Combination, Shows Efficacy in Phase 3 Acute Pain Trial
MNK-155 (hydrocodone bitartrate/acetaminophen) demonstrated significantly greater pain reduction than placebo following bunion surgery
MNK-155 is an investigational extended-release oral formulation of
hydrocodone and acetaminophen being studied for the management of
moderate to moderately severe acute pain where the use of an opioid
analgesic is appropriate. MNK-155 is formulated with both immediate- and
extended-release components. The release profile of MNK-155 combines
“In this study, MNK-155 showed rapid, significant and superior pain
relief to placebo with a 12-hour dosing interval throughout the 48-hour
study period,” said Dr.
In addition to the Phase 3 study,
The Phase 3 trial was a multicenter, randomized, double-blind, placebo-controlled, parallel-arm study comparing the efficacy and safety of MNK-155 and placebo in 403 patients with moderate to moderately severe acute pain following a unilateral first metatarsal bunionectomy. 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. Rescue ibuprofen up to 400 mg every 4 hours was allowed for both the MNK-155 and placebo arms.
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).
Lynn Phillips, 314-654-3263
Manager, Media Relations
Meredith Fischer, 314-654-6595
Senior Vice President, Communications
John Moten, 314-654-6650
Vice President, Investor Relations