Mallinckrodt Announces Positive Efficacy Results In Phase 3 Trial For MNK-155

(RTTNews) - Mallinckrodt (MNK) reported positive efficacy results in the Phase 3 trial for MNK-155, an investigational extended-release oral formulation of hydrocodone and acetaminophen studied for the management of moderate to moderately severe acute pain where the use of an opioid analgesic is appropriate. MNK-155 achieved the primary endpoint in this study.

Also, the company concluded a series of other trials evaluating pharmacokinetics, safety and abuse liability of MNK-155. These data, including the Phase 3 efficacy data, would be presented at a future medical meeting and would be submitted to the U.S. Food and Drug Administration or FDA in a New Drug Application or NDA for MNK-155. The NDA is likely to be submitted in the second half of fiscal 2014.

The Phase 3 efficacy trial assessed the efficacy and safety of MNK-155 in a post-surgical acute pain model. The primary endpoint was the summed pain intensity difference over 48 hours compared with placebo. The most common adverse events associated with the use of MNK-155 were nausea, vomiting, dizziness, headache, constipation and somnolence.