BETHESDA, MD 23 Jun 2014—Cubist Pharmaceuticals on June 20 announced the approval of tedizolid phosphate for the treatment of acute bacterial skin and skin structure infections caused by certain gram-positive bacteria.
Tedizolid phosphate is a prodrug of tedizolid, an oxazolidinone. The drug will be marketed as Sivextro and will be available in formulations for oral administration and i.v. infusion.
A Cubist spokesperson stated that the company is taking orders now for the oral formulation and expects the i.v. formulation to be available very soon.
The labeling (PDF) for tedizolid phosphate states that it is indicated for the treatment of acute bacterial skin and skin structure infections caused by methicillin-resistant and methicillin-susceptible Staphylococcus aureus and Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus group, and Enterococccus faecalis.
For both formulations, the recommended dosage is 200 mg administered once daily for six days.
The oral tablets may be administered with or without food. The i.v. formulation must be reconstituted with sterile water for injection and then diluted with 0.9% Sodium Chloride Injection, USP. The reconstituted and diluted solution should be infused over one hour, according to the labeling.
The clinical efficacy of tedizolid was compared with the response to standard therapy with linezolid in clinical trials involving adults with wound infection, major cutaneous abscess, or erysipelas or other form of cellulitis. Patients received oral or i.v. therapy or a combination of oral and i.v. therapy. According to the labeling, the early and posttreatment responses were similar for both drugs.
The most commonly reported adverse events among patients treated with tedizolid were nausea, headache, diarrhea, vomiting, and dizziness.
The labeling for tedizolid phosphate includes a warning that Clostridium difficile–associated diarrhea may develop in patients treated with systemic antimicrobials, including tedizolid.
Animal studies suggest that tedizolid's antibacterial activity may be reduced in patients with neutropenia. According to the labeling, other therapies should be considered in patients with neutropenia who require treatment for acute bacterial skin and skin structure infection.
Tedizolid phosphate 200-mg oral tablets will be available in bottles of 30 each and in six-tablet blister packs. The i.v. formulation will be supplied in packages of 10 200-mg single-use vials. The packages should be stored at controlled room temperature.