Taksta sodium fusidate: Phase II/III data

Data from 198 patients in the Phase II portion of a double-blind Phase II/III trial showed that a front-loaded dose regimen of twice-daily oral Taksta was well tolerated and displayed comparable efficacy to that of twice-daily oral Zyvox linezolid. Cempra said the results indicate that Taksta will have a high probability of demonstrating non-inferiority vs. Zyvox in Phase III trials. The company said it plans to conduct 2 pivotal Phase III non-inferiority trials for Taksta using a <10% non-inferiority margin as set by FDA. ...