Mallinckrodt product meets in Phase III pain trial

Mallinckrodt plc (NYSE:MNK) said MNK-155 met the primary endpoint vs. placebo in a Phase III trial to manage moderate to severe acute pain where the use of an opioid analgesic is appropriate. In the double-blind trial, a loading dose of three tablets of oral MNK-155 followed by two tablets every 12 hours for 48 hours improved the summed pain intensity difference from baseline over 48 hours (SPID48) vs. placebo. The trial enrolled about 400 patients with moderate to severe acute pain following a unilateral first metatarsal bunionectomy.

Mallinckrodt said it plans to submit an NDA to FDA for MNK-155 in the second half of its fiscal year ending Sept. 26, 2014. The product is an extended-release oral formulation of hydrocodone and acetaminophen formulated using the AcuForm gastric retentive formulation technology from Depomed Inc. (NASDAQ:DEPO). Mallinckrodt is developing MNK-155 under section 505(b)(2) of the Food, Drug and Cosmetic Act, which allows sponsors to reference data on safety and efficacy from the scientific literature or from previously approved products. ...