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Mallinckrodt Inc announces completion of MNK-155 clinical trials

Thursday, 12 Dec 2013 08:45am EST 

Mallinckrodt Inc:Says it reported positive efficacy results in the Phase 3 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.Says MNK-155 met the primary endpoint in this study.Says Mallinckrodt also completed a series of other clinical trials evaluating pharmacokinetics, safety and abuse liability of MNK-155.Says these data, including the Phase 3 efficacy data, will be presented at a future medical meeting and will be submitted to the U.S. Food and Drug Administration (FDA) in a New Drug Application (NDA) for MNK-155.Says NDA is expected to be submitted in the second half of fiscal 2014. 

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