Mallinckrodt plc (MNK) announced encouraging results from a phase III efficacy study on its pain candidate, MNK-155. MNK-155 achieved the primary endpoint -- a change in pain from baseline over a 48-hour period.
MNK-155, which is an extended-release oral formulation of hydrocodone and acetaminophen, is being evaluated for the management of moderate to moderately severe acute pain.
The multicenter, randomized, double-blind, placebo-controlled, parallel-arm phase III study evaluated the efficacy and safety of MNK-155 in 403 patients suffering from moderate to moderately severe acute pain following bunion surgery. Patients received either a single 3-tablet loading dose of MNK-155 followed by 2 tablets every 12 hours over 48 hours or placebo.
Data from the study revealed that the use of MNK-155 resulted in a statistical significant reduction in pain compared to placebo over a 12-hour dosing interval throughout the 48-hour study period.
Mallinckrodt presented the data at the PAINWeek national conference. Mallinckrodt also intends to present data from several other studies on MNK-155 at PAINWeek. Earlier this week, the company presented encouraging data from a human abuse liability study on MNK-155.
We note that the New Drug Application (:NDA) on MNK-155 was accepted for review by the FDA in May this year.
Mallinckrodt is actively focusing on strengthening its pipeline and promoting new products in the pain market. Mallinckrodt’s pain franchise includes products like Pennsaid 2% and Xartemis XR. Both were approved earlier this year.