E-58425: Phase II data
Top-line data from a double-blind Phase II trial in 420 patients with moderate to severe acute pain following extraction of >=2 impacted third molars showed that the 100, 150 and 200 mg doses of E-58425 met the primary endpoint of improving SPID scores from baseline at 8 hours vs. both placebo (p<0.0002 for all) and 100 mg tramadol (p<0.02 for all). The 50 mg dose of E-58425 missed the endpoint vs. both placebo and tramadol. The 3 highest doses of E-58425 also met the secondary endpoints of improving SPID scores from baseline at 12 hours and TOTPAR scores from baseline at 8 and 12 hours vs. both placebo (p<0.0002 for all) and tramadol (p<0.02 for all). Additionally, Esteve said there was a faster onset of action, longer duration of analgesia and less need for rescue medication with E-58425 compared to both placebo and tramadol. Esteve said it is seeking partners to support Phase III testing with E-58425 in both acute and chronic moderate to severe pain, but declined to disclose a time frame for when Phase III testing is slated to begin. ...