MNK-155: Additional Phase III data

Additional data from a double-blind, U.S. Phase III trial in 403 patients with moderate to severe acute pain following a unilateral first metatarsal bunionectomy showed that a loading dose of 3 tablets of oral MNK-155 followed by 2 tablets every 12 hours for 48 hours met the secondary endpoints of improving SPID36 score (p<0.001) and TOTPAR score at 48 hours (p=0.012) vs. placebo. Additionally, patients receiving MNK-155 had significantly shorter median time to perceptible (34.4 vs. 56.7 minutes, p<0.001), meaningful (118.6 minutes vs. no estimate made, p<0.001) and confirmed (55.4 minutes vs. no estimate made, p<0.001) pain relief vs. placebo. Data were presented at the PAINWeek meeting in Las Vegas. Mallinckrodt previously reported that MNK-155 met the primary endpoint of improving SPID48 scores vs. placebo (p<0.001) (see BioCentury, Dec. 16, 2013). ...