Sivextro (tedizolid phosphate) has just been approved by the US Food and Drug Administration to treat patients with acute bacterial skin and skin structure infections (ABSSSI) caused by bacterial infections including both methicillin resistant strains such as MRSA, various Streptococcus species, and Enterococcus faecalis. These are considered to be serious or life-threatening infections, and have run rampant throughout many hospitals, nursing homes, and even prisons, where patients with open wounds, invasive devices (including metal pins used to hold broken bones together), and weakened immune systems are at greater risk of infection than the general public.
Sivextro was designated as a qualified infectious disease product (QIDP) and received an expedited review following two clinical trials with 1,315 adults with ABSSSI in which 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,” according to Edward Cox, M.D., M.P.H, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. The Food and Drug Administration, also granted its qualified infectious disease product status for an additional five years of marketing exclusivity to Cubist Pharmaceuticals, of Lexington, MA to be added to certain exclusivity periods already provided by the Food, Drug and Cosmetic Act.
The most common side effects reported during the clinical trials were nausea, headache, diarrhea, vomiting and dizziness. The safety and efficacy of Sivextro, however, have not been evaluated in patients with decreased levels of white blood cells. Available for both oral and intravenous application, Sivextro is the 2nd new antibacterial drug approved by the FDA in less than a month treat ABSSSI. The first was Dalvance (dalbavancin), which received the agency’s stamp of approval on May 23rd to treat patients skin infections caused by Staphylococcus aureus and various Streptococcus species.