Nabriva Therapeutics Enters into Exclusive Agreement to Promote and Distribute SIVEXTRO (tedizolid phosphate) in the U.S. - Seite 2

“Our new partnership with Amplity Heath provides us the opportunity to build a flexible and scalable commercial infrastructure that enables us to optimize the uptake of both SIVEXTRO and XENLETA, while mitigating potential risks associated with the evolving COVID-19 pandemic. Amplity has the experience and depth to effectively educate prescribers about the appropriate use of both of these important antibiotics.  We look forward to educating clinicians about the differentiating attributes of both products and bringing these important treatment options to patients,” said Mr. Schroeder. 

About Acute Skin, Skin Structure and Soft Tissue Infections (ABSSSI)

Acute bacterial skin and skin structure infections (ABSSSIs) are common and often require antibiotic treatment. According to the U.S. Food and Drug Administration (FDA), these infections can be uncomplicated – simple abscesses, cellulitis or wound infections mainly caused by the two most common Gram-positive pathogens, Staphylococcus aureus and Streptococcus pyogenes. They can also be complicated either involving deeper soft tissue or requiring surgery – such as ulcers, burns and major abscesses or involving a significant underlying disease state. ABSSSIs are at least 75 cm².

About SIVEXTRO (tedizolid phosphate)

SIVEXTRO was approved by the FDA in 2014. It is indicated in adults and pediatric patients 12 years of age and older for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: 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 Enterococcus faecalis. MRSA has been categorized by the U.S. Centers for Disease Control and Prevention (CDC) as a serious public health threat.¹ SIVEXTRO 200 mg is administered once daily orally or as an intravenous (IV) infusion over one hour for six days.

Selected Important Safety Information for SIVEXTRO

Patients with neutropenia: The safety and efficacy of SIVEXTRO in patients with neutropenia (neutrophil counts <1000 cells/mm³) have not been adequately evaluated. In an animal model of infection, the antibacterial activity of SIVEXTRO was reduced in the absence of granulocytes. Alternative therapies should be considered when treating patients with neutropenia.