Naurex heads for Phase III on unexpected results

Naurex Inc. (Evanston, Ill.) intends to begin a Phase III trial next year of GLYX-13 as an adjunctive therapy to treat major depressive disorder (MDD) even though the compound missed the primary endpoint of a Phase IIb trial. The company said GLYX-13's effects unexpectedly lasted longer than the trial's withdrawal period.

The study's 386 patients were first given IV GLYX-13 for six weeks to stabilize treatment, then were randomized into treatment or placebo arms for another six weeks, followed by a four-week wash-out period. The primary endpoint was difference in Hamilton Depression Rating Score (HDRS-17) between the treatment and placebo arms during the second six-week period. ...