Cara's oral analgesic misses in Phase IIb

Cara Therapeutics Inc. (NASDAQ:CARA) reported top-line data from the Phase IIb CLIN2002 trial in 476 patients with osteoarthritis (OA) of the hip or knee who were experiencing moderate to severe pain showing that twice-daily 1, 2.5 and 5 mg doses of oral CR845 all missed the primary endpoint of improving the weekly mean of the daily pain intensity score using a numerical rating scale (NRS) from baseline to week 8 vs. placebo. The trial included a 4-week titration period followed by a 4-week maintenance period.

In patients maintained on the 5 mg dose of CR845 at the end of the 8-week treatment period, CR845 led to a non-significant 35% reduction in mean joint pain score vs. placebo (p=0.111). In only patients with OA of the hip, high-dose CR845 led to a significant 39% reduction in mean joint pain score vs. placebo (p=0.043). Additionally, a significantly greater proportion of patients maintained on the 5 mg dose of CR845 at the end of the 8-week treatment period achieved a Patient Global Assessment (PGA) score of "much improved" or "very much improved" vs. placebo in both the total patient population and in patients with OA of the hip (p<0.005 and p<0.006, respectively). Furthermore, high-dose CR845 reduced mean rescue medication use by 41% from baseline to week 8 vs. placebo. CR845 was generally well tolerated with no treatment-related serious adverse events reported...