Mallinckrodt, a global specialty pharmaceutical company, has reported positive efficacy results in the phase III 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. MNK-155 met the primary endpoint in this study.

Mallinckrodt also completed a series of other clinical trials evaluating pharmacokinetics, safety and abuse liability of MNK-155. These data, including the phase III efficacy data, will be presented at a future medical meeting and will be submitted to the US Food and Drug Administration (FDA) in a New Drug Application (NDA) for MNK-155. The NDA is expected to be submitted in the second half of fiscal 2014.

“Despite the number of available pain medications, some patients continue to experience unresolved pain. Our goal is to provide another treatment option for the management of moderate to moderately severe acute pain for patients and their physicians,” said Mario Saltarelli, chief science officer, Mallinckrodt. “We are encouraged by these findings and look forward to submitting these results to the FDA as part of our application.”

The phase III efficacy study evaluated the efficacy and safety of MNK-155 in a post-surgical acute pain model. The primary endpoint was the summed pain intensity difference (change in pain from baseline) over 48 hours (SPID48) compared to placebo. The most common adverse events associated with the use of MNK-155 were nausea (25 per cent), vomiting, dizziness, headache, constipation and somnolence (sleepiness).

Mallinckrodt is a global specialty pharmaceutical business that develops, manufactures, markets and distributes specialty pharmaceutical products and medical imaging agents.