Updated 07 August 2014

FDA approves drug to treat acute skin infections

Sivextro is designed to treat serious acute bacterial skin and skin structure infections – infections that involve deep tissue or are associated with underlying diseases like diabetes.


The US Food and Drug Administration has approved a new antibacterial drug, Sivextro (tedizolid phosphate), to treat adults with skin infections.

Sivextro, from Cubist Pharmaceuticals, is designed to treat serious acute bacterial skin and skin structure infections, or ABSSSI. These are infections that involve deep tissue or are associated with an underlying disease such as diabetes.

Approval of Sivextro follows on the heels of the FDA's approval of a drug for the same condition made by Durata Therapeutics Inc. known as Dalvance, or dalbavancin.

Problematic in US

The drugs target gram-positive infections, including methicillin-resistant Staphylococcus aureus, or MRSA. Sivextro is given once daily for six days. Dalvance is given in two doses, eight days apart.

"MRSA is still problematic in the US and is responsible for the deaths of more than 11,000 Americans each year," Dr. Ralph Corey, professor of medicine and infectious disease at Duke University Medical Centre, said in a statement. "Not every antibiotic will work for every patient and more drug options are an imperative."

The main treatment for MRSA is vancomycin, which is available generically.

Sivextro received an expedited review by the FDA and was designated a qualified infectious disease product, meaning it qualifies for an extra five years of marketing exclusivity.

Alternative therapies should be considered

The most common side effects of the drug were nausea, headache, diarrhoea, vomiting and dizziness.

Read: Dodging antibiotic side effects

Sivextro's safety and efficacy were evaluated in two clinical trials with 1,315 adults with ABSSSI. Participants were randomly assigned to receive Sivextro or linezolid, another antibacterial drug approved to treat ABSSSI. Results showed Sivextro was as effective as linezolid for the treatment of ABSSSI.

The safety and efficacy of Sivextro have not been evaluated in patients with decreased levels of white blood cells (neutropenia), so alternative therapies should be considered, the FDA said.

Read more:
Skin infections spread easily amongst athletes
What causes skin disease?
How stress harms your skin


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