Tedizolid for treatment of acute bacterial skin and skin structure infections

Abstract

Tedizolid is a newly approved drug of the oxazolidinone class. It has high in vitro activity against Gram-positive bacteria, including multidrug-resistant strains. Peak plasma concentration of tedizolid is obtained within 3 h of oral dosing (PO), with high bioavailability. Tedizolid is mostly metabolized via the liver, and is excreted in feces in the form of a sulfate conjugate. Tedizolid 200 mg taken once daily demonstrated non-inferior efficacy and a good safety profile in patients with acute bacterial skin and skin structure infections. Results of two pivotal Phase III clinical trials showed that 6 days of 200 mg tedizolid PO or sequential intravenous (IV)/PO once-daily treatment was non-inferior to 10 days of 600 mg linezolid PO or sequential IV/PO twice-daily treatment at 48–72 h (primary end point) and at the test-of-cure in patients with acute bacterial skin and skin structure infections. The Phase II and Phase III trials also demonstrated that tedizolid was well tolerated.

Keywords:

• acute bacterial superficial skin structure infections
• efficacy
• pharmacodynamics
• pharmacokinetics
• safety
• tedizolid

Financial & competing interests disclosure

The authors have no relevant affiliation or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

No writing assistance was utilized in the production of this manuscript.

Key issues

• Tedizolid is a promising new oxazolidinone drug that has significant antibacterial activity against multidrug resistant Gram-positive cocci.

• Tedizolid has a long half-life, high oral bioavailability, low incidence of interaction with other drugs, and good safety profile in vivo and in clinical trials.

• Tedizolid potentially offers advantages over existing medications used to treat acute bacterial skin and skin structure infections caused by Gram-positive bacteria.

Notes