The NDA was based on positive efficacy results from a Phase III clinical trial, in addition to a series of other clinical trials assessing pharmacokinetics, safety and abuse liability of MNK-155.
The company recently received notice of allowance from the US Patent and Trademark Office related to MNK-155’s composition and release profile.
The release profile of the product combines the company’s proprietary technology and Depomed’s advanced Acuform drug delivery technology.
Between the Mallinckrodt and Depomed patent families, the Irish firm believes MNK-155 will have strong patent protection for its novel features.
Mallinckrodt chief science officer Mario Saltarelli said hydrocodone combination products are the most frequently prescribed medications in the country, according to recent IMS data.
"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," Saltarelli said.
"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."