Mallinckrodt has released positive efficacy results from the Phase III clinical trial of MNK-155, an investigational extended-release oral formulation of hydrocodone and acetaminophen evaluated for the management of moderate to moderately severe acute pain where the use of an opioid analgesic is suitable.
According to the company, the MNK-155 met the primary endpoint in the trial.
The company has also completed a series of other clinical trials assessing pharmacokinetics, safety and abuse liability of MNK-155.
Mallinckrodt chief science officer Mario Saltarelli said 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," Saltarelli said.
"We are encouraged by these findings and look forward to submitting these results to the FDA as part of our application."
The data, including the Phase III efficacy, 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 in the second half of fiscal 2014.
The Phase III efficacy trial assessed the efficacy and safety of MNK-155 in a post-surgical acute pain model and the primary endpoint was the summed pain intensity difference (change in pain from baseline) over 48 hours (SPID48) compared to placebo.
In the trial, the most common adverse events associated with the use of MNK-155 were nausea (25%), vomiting, dizziness, headache, constipation and somnolence (sleepiness).
MNK-155 is developed based on Depomed’s Acuform Drug-delivery technology platform and is currently under development for the treatment of osteoarthritis of the knee or hip, moderate to severe chronic low back pain and acute pain.
It is administered orally and is a reformulation of existing controlled substance analgesic combination products.