New antimicrobials for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by such microorganisms as Staphylococcus aureus, including methicillin-resistant strains (MRSA) and a variety of Streptococcal species have passed through the Food and Drug Administration (FDA) during the past month bringing new options to physicians and patients alike for the treatment of these infections.
The most recent occurred June 20 as the FDA announced the approval of Cubist Pharmaceutical’s, Sivextro (tedizolid phosphate). The newly approved antibacterial will be available in both oral and intravenous forms for the treatment of a variety of hard to treat gram positive skin infections.
“Today’s approval provides physicians and patients with a new treatment option for serious skin infections,” said Edward Cox, M.D., M.P.H, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.
Three months ago, Cubist announced the U.S. Food and Drug Administration (FDA) Anti-Infective Drugs Advisory Committee (AIDAC) voted unanimously (14-0) for the approval of the then investigational oxazolidinone antibiotic.
The other MRSA antibiotic approval occurred on May 23 as the FDA approved Durata Therapeutics, Dalvance. The intravenous-only drug is intended to treat acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria like Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains) and Streptococcus pyogenes (Group A Strep).
These new antimicrobials come as the Infectious Diseases Society of America (IDSA) issued new guidelines for the diagnosis and management of SSTIs as the number of such infections has skyrocketed due to the spread of MRSA.
Outside the United States, Swiss-based global biopharmaceutical company, Debiopharm, announced this week the launch of a Phase 1 dose-escalation study of Debio 1450 (previously known as AFN-1720), a highly potent anti-infective agent that is selectively active against a large number of Staphylococcus species, including all known resistant strains such as methicillin-resistant S. aureus (MRSA) and vancomycin-intermediate S. aureus (VISA).
The Centers for Disease Control and Prevention (CDC) says Methicillin-resistant Staphylococcus aureus (MRSA) is a bacteria that is resistant to many antibiotics. In the community, most MRSA infections are skin infections. In medical facilities, MRSA causes life-threatening bloodstream infections, pneumonia and surgical site infections. In the United States alone, 278,000 people are hospitalized and 19,000 die each year from infections caused by MRSA.