Sivextro Approval Expanded to Include Pediatric Patients

The FDA has expanded the approval of Sivextro.

The Food and Drug Administration (FDA) has expanded the approval of Sivextro (tedizolid phosphate; Merck) to include patients aged 12 to less than 18 years for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-resistant [MRSA] and methicillin-susceptible [MSSA] isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus Group (including Streptococcus anginosus, Streptococcus intermedius, and Streptococcus constellatus), and Enterococcus faecalis. Previously, Sivextro was only approved for adults.

The approval was based on data from a single blind, active-controlled phase 3 trial that evaluated 120 patients aged 12 to <18 years with clinically documented ABSSSI. Patients were randomized 3:1 to receive tedizolid 200mg once daily for 6 days (n=91), or comparator treatment for 10 days (n=29);  the most frequently used comparator agents were cefazolin (n=11) and vancomycin (n=8).

The primary end point of the study was the safety and tolerability of tedizolid. Key secondary end points included the clinical success at test of cure defined as resolution or near resolution of all related signs and symptoms with no further therapy needed, and early clinical response defined as ≥20% reduction in lesion size at 48-72 hours after initiation.

Results showed 96.7% (n=88) of tedizolid-treated patients achieved clinical success at test of cure compared with 93.1% (n=27) in the comparator arm (difference 3.6%; 95% CI, -6.3-13.5). Moreover, early clinical response was observed in 92.3% of patients in the tedizolid arm (n=84) and 96.6% of patients (n=28) in the comparator arm (difference -4.2; 95% CI, -12.9-4.4). With regard to safety, the most common adverse reactions in pediatric patients were phlebitis and increased hepatic transaminases. 

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Sivextro is supplied as 200mg tablets in either 30-count bottles or 6-count blister packs, along with 200mg single-dose vials in a carton of 10.

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