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Positive Pivotal Data Reported for Tedizolid Phosphate (Sivextro) in Treatment of Skin Infections

Treatment noninferior to linezolid in phase III trial

Positive results have been reported from a pivotal phase III trial of the investigational antibiotic agent tedizolid phosphate (Sivextro, Cubist Pharmaceuticals), which is being developed for the treatment of acute bacterial skin and skin-structure infections (ABSSSIs) and complicated skin and soft-tissue infections (cSSTIs).

The results have been reported online in The Lancet Infectious Diseases.

Tedizolid is a once-daily oxazolidinone being developed for both intravenous (IV) and oral administration for the treatment of serious infections caused by certain gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA).

The published data are based on results from the global ESTABLISH-2 trial, which met its primary and secondary endpoints. One of the study’s objectives was to evaluate the efficacy and safety of the IV-to-oral transition of tedizolid in the treatment of ABSSSIs. The randomized, controlled trial compared tedizolid 200 mg, given as a once-daily dose for 6 days, with linezolid 1,200 mg, divided as a twice-daily dose for 10 days, both administered intravenously, with a possible switch to oral treatment when prespecified criteria were met.

The results showed that a 6-day course of once-daily tedizolid was non-inferior to 10 days of twice-daily linezolid for the treatment of ABSSSIs. The adverse event rates were similar for both tedizolid- and linezolid-treated patients. Gastrointestinal adverse events (i.e., diarrhea, nausea, and vomiting) were the most commonly reported adverse events in both treatment groups.

Data from the ESTABLISH-2 study, along with findings from the previously published ESTABLISH -1 trial, served as the basis for a new drug application (NDA) for tedizolid for the treatment of ABSSSIs. The FDA accepted the NDA in December 2013 for priority review, assigning a Prescription Drug User Fee Act (PDUFA) action date of June 20, 2014. On March 31, 2014, the FDA’s Anti-Infective Drug Advisory Committee (AIDAC) voted unanimously to recommend approval of tedizolid.

Tedizolid phosphate (formerly known as TR-701) is an oxazolidinone antibiotic drug candidate that is rapidly converted in vivo by phosphatases to the microbiologically active moiety TR-700. TR-700 acts by binding to the bacterial 50S ribosomal subunit, thereby inhibiting protein synthesis.

Tedizolid is being developed for both IV and oral administration for the potential treatment of ABSSSIs. The drug is also being investigated for potential use in nosocomial pneumonia (i.e., hospital-acquired bacterial pneumonia [HABP] and ventilator-associated bacterial pneumonia [VABP]).

Source: Cubist Pharmaceuticals; June 6, 2014.

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