Mallinckrodt announced that the FDA has accepted a New Drug Application (NDA) for filing for MNK-155.

MNK-155 is an investigational extended-release oral formulation of hydrocodone and acetaminophen that has been evaluated for the management of moderate to moderately severe acute pain where the use of an opioid analgesic is appropriate. The release profile of MNK-155 consists of Mallinckrodt-proprietary technology and Depomed’s advanced Acuform drug delivery technology.

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

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