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Mallinckrodt's New Drug Application Accepted for Review by FDA

Wed, 05/28/2014 - 8:16am

Mallinckrodt today announced that the 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.

“Hydrocodone combination products are the most frequently prescribed medications in the country, according to recent IMS data,” said Dr. Mario Saltarelli, Chief Science Officer, Mallinckrodt. “But we believe that there’s a very real need to pause and consider whether this familiar combination can be delivered to patients in a way that can last longer than 4-6 hours. We’re pleased that the FDA has accepted the MNK-155 New Drug Application filing for review, as the product may fill an important need in the marketplace. Furthermore, our allowed patent claims, which include claims to the product’s release profile, highlight our ability to effectively leverage our core formulation capabilities and partnerships.”

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