FDA approves new drug for skin infections

The Food and Drug Administration has approved Sivextro (tedizolid phosphate, Cubist Pharmaceuticals) for the treatment of acute skin infections.

Sivextro an intravenous and oral drug that is for adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by certain bacteria, including Staphylococcus aureus, certain Streptococcus species and Enterococcus faecalis, according to a news release.

The drug’s efficacy and safety were examined in two clinical trials of 1,315 patients with ABSSSI. Patients were randomly assigned to receive Sivextro or the antibacterial drug linezolid.

“These studies demonstrated that Sivextro 200 mg administered once daily for six days was statistically noninferior to 600 mg of linezolid taken twice a day for 10 days,” the company stated in a news release.

Sivextro is administered once daily and provides a six-day course of therapy. It is an oxazolidinone with in vitro activity against susceptible Gram-positive pathogens such as methicillin-resistant Staphylococcus aureus (MRSA), according to the company.

The Sivextro application was designated as a qualified infectious disease product (QIDP) due to its treatment of serious and life-threatening infections, and thus received from the FDA an expedited review. The designation allows Sivextro to qualify for an additional five years of marketing exclusivity on top of some of the exclusivity periods already given by the Food, Drug and Cosmetic Act, according to the FDA.

“Sivextro provides physicians with flexibility to transition patients from I.V. to oral treatment as required,” Michael Bonney, Cubist chief executive officer, stated in the news release. “The oral option provides opportunity for out-patient care, which could reduce the need for costly hospitalization.”

In May, the FDA approved another drug, Dalvance (dalbavancin, Durata Therapeutics), also for the treatment of ABSSSI.