The treatments are Sivextro (tedizolid phosphate), from Cubist Pharmaceuticals, and Dalvance (vancomycin-linezolid combination), from Durata Therapeutics. Sivextro is a daily oral or intravenous drug, while Dalvance is a weekly IV treatment.
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Both drugs successfully completed phase III clinical trials to be considered for approval, according to a Medscape report. However, the drugs will be subject to postmarket safety monitoring, as concerns raised during public hearings included a lack of diversity in the study populations and use of drug-to-drug efficacy comparisons instead of drug-to-disease efficacy comparisons.
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