Dex-IN: Phase IIb discontinued

Recro discontinued the double-blind, placebo-controlled, U.S. Phase IIb REC-13-012 trial evaluating 35 and 50 Ug intranasal Dex-IN starting on post-operative day 0 in 68 patients undergoing bunionectomy after an interim analysis of the primary endpoint of SPID48 score showed that Dex-IN was not sufficient to manage severe pain in bunionectomy on post-operative day 0. In a subgroup of patients with a baseline pain intensity score of <=6 points (n=34) and who completed 48 hour pain assessments, mean SPID48 scores were 48.67 points for 50 Ug Dex-IN vs. -10.6 points for placebo (higher SPID48 scores indicate greater pain relief). Additionally, high-dose Dex-IN reduced the mean amount of rescue medication used by about 50% vs. placebo. No serious adverse events were reported. ...