ARTICLE | Clinical News
Melinta's Baxdela passes second Phase III test
May 13, 2016 12:37 AM UTC
Melinta Therapeutics Inc. (New Haven, Conn.) said IV-to-oral Baxdela delafloxacin (RX-3341) was non-inferior to the standard-of-care regimen of vancomycin plus aztreonam, meeting the primary endpoints of a Phase III study to treat acute bacterial skin and skin structure infections (ABSSSI). In January 2015, the IV formulation alone met the primary endpoints of another Phase III study to treat ABSSSI.
CEO Eugene Sun told BioCentury that Melinta intends to submit separate NDAs next half for IV and IV-to-oral Baxdela to treat ABSSI. ...