A lasting impression
Why Naurex's GLYX-13 for depression may succeed in Ph III after Ph IIb miss
It appears the longer-than-expected duration of benefit for depression candidate GLYX-13 did not pair well with the crossover design of Naurex Inc.'s Phase IIb study. The company thinks the more traditional Phase III program it has planned will demonstrate the efficacy and safety advantage of the compound over marketed antidepressants.
GLYX-13, an intravenous partial agonist of the glycine site of the NMDA receptor, missed the primary endpoint in an adaptive crossover study in depressed patients who had relapsed after at least one prior therapy. The crossover design called for all 386 patients to receive study drug prior to randomization, and the primary endpoint was a difference in Hamilton Depression Rating Score (HDRS-17) between subjects who continued receiving GLYX-13 after randomization, and those who received placebo. ...