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New Drug Application for Hydrocodone/Acetaminophen Combo Accepted for Review

Phase III trial provides positive efficacy results

The FDA has accepted a new drug application (NDA) for MNK-155 (Mallinckrodt).

MNK-155 is 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. It is formulated with Acuform drug delivery technology (Depomed).

The NDA submission was based on positive efficacy results in a phase III clinical trial, in addition to a series of other clinical studies evaluating the pharmacokinetics, safety, and abuse liability of MNK-155.

The phase III 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 (i.e., the change in pain from baseline) over 48 hours compared with placebo. The most common adverse events associated with the use of MNK-155 were nausea (25%), vomiting, dizziness, headache, constipation, and somnolence.

Sources: Mallinckrodt; May 28, 2014; and Mallinckrodt; December 12, 2013.

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