MNK 155 positive in Phase III trial for Moderate to Severe Pain-Mallinckrodt
Mallinckrodt reported positive efficacy results in the Phase III clinical 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 met the primary endpoint in this study. Mallinckrodt also completed a series of other clinical trials evaluating pharmacokinetics, safety and abuse liability of MNK-155.
The Phase III efficacy study evaluated the efficacy and safety of MNK-155 in a post-surgical acute pain model. The primary endpoint was the summed pain intensity difference (change in pain from baseline) over 48 hours (SPID48) compared to placebo. The most common adverse events associated with the use of MNK-155 were nausea (25%), vomiting, dizziness, headache, constipation and somnolence (sleepiness).An NDA is expected to be submitted to the FDA in the second half of fiscal 2014.
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