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Trials & Filings

Mallinckrodt Pain Drug Meets Endpoint

Extended release of hydrocodone and acetaminophen also studied for PK, safety and abuse liability

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Mallinckrodt has posted positive efficacy results in its Phase III trial of MNK-155, an investigational extended-release oral formulation of hydrocodone and acetaminophen, in 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. These data, including the Phase III efficacy data, will be presented at a future medical meeting and will be submitted to the FDA in MNK-155’s NDA, which is expected to be submitted in the 2H14.

The trial 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.

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