Mallinckrodt plc today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for MNK-155. 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.

The NDA submission was based on positive efficacy results in a Phase 3 clinical trial, in addition to a series of other clinical trials evaluating pharmacokinetics, safety and abuse liability of MNK-155.

Mallinckrodt recently received notice of allowance from the United States Patent and Trademark Office related to composition claims directed to unique design, formulation, pharmacokinetic, and release characteristics for MNK-155. The release profile of MNK-155 combines Mallinckrodt-proprietary technology and Depomed’s advanced Acuform drug delivery technology. Between the Mallinckrodt and Depomed patent families, Mallinckrodt believes MNK-155 will have strong patent protection for its novel features.

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