Mallinckrodt reported that a Phase 3 efficacy trial of investigational MNK-155 met the study’s primary endpoint of improved pain scores vs. placebo over the first 48 hours following bunionectomy (p<0.001). This difference in pain scores was statistically significant in favor of MNK-155. The data is being presented at PAINWeek 2014, a national conference on pain for frontline practitioners, held in Las Vegas, Nevada.
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 Mallinckrodt-proprietary, patented technology and Depomed’s advanced Acuform drug delivery technology. The NDA for MNK-155 was accepted for review by the U.S. Food and Drug Administration in May 2014 and included results from this study.
“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. Mario Saltarelli, chief science officer, Mallinckrodt Pharmaceuticals. “These positive Phase 3 findings are great news as we strive to develop new medications with less frequent dosing for patients with acute pain.”
In addition to the Phase 3 study, Mallinckrodt will present data at PAINWeek from several other MNK-155 trials, including the pharmacokinetics, safety and subjective effects of abuse-related characteristics.
Date: September 4, 2014
Source: Mallinckrodt
