NAPSR news: FDA approves Cubist Pharmaceuticals Sivextro for treatment of skin infections

WASHINGTON - June 23, 2014 - PRLog -- SIVEXTRO™ (tedizolid phosphate) is indicated for the treatment of acute bacterial skin infections (ABSSSI) caused by vulnerable isolates of Gram-positive pathogens, which includes: Staphylococcus aureus (including methicillin-resistant [MRSA] and methicillin-susceptible [MSSA] isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus group (including Streptococcus anginosus, Streptococcus intermedius and Streptococcus constellatus), and Enterococccus faecalis. Methicillin-resistant Staphylococcus aureus (MRSA) is known to be resistant to other antibiotic treatments. In the community, most MRSA infections are skin infections which pose a serious public health threat according to the US Centers for Disease Control and Prevention (CDC).

The new drug application (NDA) for SIVEXTRO was sustained by two global Phase 3 studies. These studies confirmed that SIVEXTRO 200 mg administered once daily for six days was statistically non-inferior to 600 mg of linezolid taken twice a day for 10 days. SIVEXTRO is one of the first medicines approved in the U.S. that the FDA selected as a Qualified Infectious Disease Product (QIDP) for its indication, ABSSSI, according to the Generating Antibiotic Incentives Now (GAIN) Act of 2012. SIVEXTRO qualifies for certain incentives related to the development of new antibiotics, including a five year extension of Hatch-Waxman exclusivity.

“We are pleased by the FDA approval of SIVEXTRO, which provides a new option for physicians to treat patients with serious bacterial skin infections, including those caused by MRSA,” said Michael Bonney, Chief Executive Officer of Cubist. “SIVEXTRO provides physicians with flexibility to transition patients from I.V. to oral treatment as required. The oral option provides opportunity for out-patient care, which could reduce the need for costly hospitalization

“MRSA is still problematic in the U.S. and is responsible for the deaths of more than 11,000 Americans each year,” said Ralph Corey, M.D., Professor of Medicine and Infectious Disease, Duke Clinical Research Institute and Duke University Medical Center. “Not every antibiotic will work for every patient and more drug options are an imperative. Physicians should evaluate the use of SIVEXTRO. A six-day course of therapy with the option to choose—and, if needed—change from I.V. to oral administration is a welcome new development.”

The treatment options available for SIVEXTRO will certainly be valuable to patients who are inflicted with these debilitating infections.

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