ARTICLE | Clinical News
Iclaprim: Phase III started
March 7, 2016 8:00 AM UTC
Motif began the identical, double-blind, international Phase III REVIVE-1 and REVIVE-2 trials to evaluate IV iclaprim twice daily for 5-14 days vs. IV vancomycin in about 1,200 total patients. FDA issued a complete response letter in 2009 for iclaprim to treat complicated skin and skin structure infections (cSSSIs) when the compound belonged to Arpida Ltd. That company also withdrew an MAA for iclaprim to treat cSSSIs after a negative opinion from EMA’s CHMP. ...