Tedizolid, an oxazolidinone antibacterial drug, has been approved as an intravenous and oral treatment for acute bacterial skin and skin structure infections caused by gram positive bacteria, the Food and Drug Administration announced on June 20.
Tedizolid (Sivextro) is approved to treat patients with acute bacterial skin and skin structure infections (ABSSSI) caused by methicillin-resistant and methicillin-susceptible strains of Staphylococcus aureus, various streptococcus species, and Enterococcus faecalis.
At a meeting in March, the FDA’s Anti-infective Drugs Advisory Committee unanimously recommended that tedizolid be approved. The drug is the second new antibacterial drug to be approved by the FDA in the past month to treat ABSSSI. On May 23, the agency approved dalbavancin (Dalvance) to treat patients with ABSSSI caused by Staphylococcus aureus and various streptococcus species. Both drugs were designated as qualified infectious disease products, allowing them an additional 5 years of marketing exclusivity.
Tedizolid’s safety and efficacy were evaluated and shown to be as effective as linezolid in two clinical trials with 1,315 adults randomly assigned to receive tedizolid or linezolid.
One of the phase III studies, the ESTABLISH-2 study, an international, randomized study, compared 6 days of treatment with intravenous tedizolid to 10 days of treatment with IV linezolid in 666 patients with acute bacterial skin and skin structure infections, with the option of switching to oral treatment. The lesions were at least 75 cm2 in size, and were known to be or were suspected to be associated with gram-positive bacteria. Half the patients had cellulitis, 20% had a major cutaneous abscess, and about 30% had an infected wound; about 27% had MRSA.
The primary endpoint, an early clinical response (at least a 20% reduction in the lesion area 48-72 hours after starting treatment), was achieved by 85% of those treated with tedizolid and by 83% of those treated with linezolid, a difference that met the non-inferiority margin. Clinical responses were also similar at 7-14 days. At late follow-up, 18-25 days after the end of treatment, outcomes of MRSA infections "matched the overall results," according to the study, which was published online in the Lancet Infectious Diseases.
Fewer patients on tedizolid (16%) developed gastrointestinal-related adverse events than those on linezolid (20%); otherwise, treatment- associated adverse events were similar in the two groups.
Tedizolid has not been evaluated in neutropenic patients, so alternative therapies should be considered, the FDA said in its statement announcing the approval.
Sivextro is marketed by Cubist Pharmaceuticals.