TRV130: Phase II data
Top-line data from a 2-part, double-blind, U.S. Phase IIa/b trial in 333 patients who underwent first metatarsal bunionectomy showed that 2 and 3 mg TRV130 every 3 hours each met the primary endpoint of reducing pain intensity from baseline to 48 hours vs. placebo. Relative to placebo, the average reduction in pain score was 1.4 points with low-dose TRV130 (p=0.0024) and 2.4 points with high-dose TRV130 (p<0.0001). Additionally, 0.5 and 1 mg TRV130 non-significantly reduced pain intensity from baseline to 48 hours relative to placebo (0.5 and 0.3 points, respectively). Furthermore, high-dose TRV130 significantly reduced pain intensity vs. 4 mg morphine every 4 hours (p=0.014). In the first 3 hours after the initial dose, TRV130 significantly reduced mean pain intensity at the 1 mg (1 point, p=0.021), 2 mg (2.4 points, p<0.0001) and 3 mg (3 points, p<0.0001) doses relative to placebo. During that time period, 2 and 3 mg TRV130 also significantly reduced pain score vs. morphine (relative reductions of 1.2 and 1.8 points, respectively, p=0.0029 and p<0.0001). ...