|Trade names||Orbactiv, Kimyrsa, Tenkasi, others|
|Drug class||Antibiotic (lipoglycopeptide)|
|Main uses||Skin and skin structure infections|
|Side effects||Diarrhea, nausea, dizziness, headache, itchiness, fever, liver problems|
|Typical dose||1,200 mg|
|Chemical and physical data|
|Molar mass||1793.12 g·mol−1|
|3D model (JSmol)|
Oritavancin, sold under the brand name Orbactiv among others, is an antibiotic used to treat skin and skin structure infections such as cellulitis and skin abscesses. It is also effective against MRSA. It is given by injection into a vein.
Common side effects include diarrhea, nausea, dizziness, headache, itchiness, fever, and liver problems. Safety in pregnancy is unclear. It is a glycopeptide specifically a lipoglycopeptide and is similar to vancomycin. It works by stopping bacteria from making their cell wall.
Oritavancin was approved for medical use in the United States in 2014 and Europe in 2015. In the United States a course of treatments costs about 3,000 USD. It; however, is not commercially available in the United Kingdom or Europe as of 2021.
Spectrum of activity
Oritavancin is active against gram-positive aerobic bacteria such as enterococci, staphylococci, streptococci, and anaerobic bacteria such as Clostridium difficile , Clostridium perfringens , Peptostreptococcus spp. , and Propionibacterium acnes. Oritavancin’s spectrum of activity shows similarities to vancomycin, but with lower minimum inhibitory concentrations (MIC).
It is generally given as a single dose of 1,200 mg.
Originally discovered and developed by Eli Lilly, oritavancin was acquired by InterMune in 2001 and then by Targanta Therapeutics in late 2005. In December 2008, the U.S. Food and Drug Administration (FDA) declined to approve oritavancin without additional studies, and an EU application was withdrawn.
In 2009, The Medicines Company acquired the development rights, completed clinical trials and submitted a new drug application to the FDA in February 2014. On August 6, 2014, the United States FDA approved oritavancin to treat skin infections.
Oritavancin shares certain properties with other members of the glycopeptide class of antibiotics, which includes vancomycin, the current standard of care for serious Gram-positive infections in the United States and Europe. It possesses potent and rapid bactericidal activity in vitro against a broad spectrum of both resistant and susceptible Gram-positive bacteria, including Staphylococcus aureus, MRSA, enterococci, and streptococci. Oritavancin was more active than either metronidazole or vancomycin against strains of Clostridium difficile tested.
Oritavancin has potential use as a therapy for exposure to Bacillus anthracis, the Gram-positive bacterium that causes anthrax, having demonstrated efficacy in a mouse model both before and after exposure to the bacterium.
oritavancin demonstrates in vitro activity against both the planktonic and biofilmstates of staphylococci associated with Prosthetic joint infection (PJI), albeit with increased minimum biofilm bactericidal concentration (MBBC) compared to Minimum inhibitory concentrations (MIC) values. Moreever oritavancin has demonstrated activity against in vitro to vancomycin-susceptible enterococci (VSE) and vancomycin-resistant enterococci (VRE) in both planktonic and biofilm states.
In 2003, results were presented from two pivotal phase-III clinical trials testing the efficacy of daily intravenous oritavancin for the treatment of acute bacterial skin and skin-structure infections (ABSSSI) caused by Gram-positive bacteria. The primary endpoints of both studies were met, with oritavancin achieving efficacy with fewer days of therapy than the comparator agents vancomycin followed by cephalexin. Oritavancin showed a statistically significant improved safety profile with a 19% relative reduction in the overall incidence of adverse events versus vancomycin/cephalexin in the second and larger pivotal trial.
Osteomyelitis remains a formidable foe in an era of increasing incidence of Methicillin-resistant Staphylococcus aureus (MRSA) with limited guidance for treatment optimization. The success observed in many patients suggests multi-dose oritavancin may prove advantageous for chronic osteomyelitis but further research is needed to define the optimal dose and frequency of oritavancin for the treatment of chronic osteomyelitis.
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- 2007 ICAAC Posters: E-1612 “In Vitro Activity Profile of Oritavancin against a Broad Spectrum of Aerobic and Anaerobic Bacterial Pathogens”/E -1613 “In Vitro Activity Profile of Oritavancin (ORI) Against Organisms Demonstrating Key Resistance Profiles to Other Antimicrobial Agents”/E-1614 “In vitro Time Kill Studies of Oritavancin against Drug-resistant Isolates of Staphylococcus aureus and Enterococci”/E-1615 “Anti-Enterococcal Activity Profile of Oritavancin, a Potent Lipoglycopeptide under Development for Use Against Gram-Positive Infections”/E-1616 “Anti-Streptococcal Activity Profile of Oritavancin, a Potent Lipoglycopeptide under Development for Use Against Gram-Positive Infections”/E-1617 “In Vitro Activity Profile of Oritavancin (ORI) Against Resistant Staphylococcal Populations From a Recent Surveillance Initiative”/E-1620 “Pharmacokinetic Concentrations of Oritavancin Kill Stationary-Phase and Biofilm Staphylococcus aureus In Vitro.” / Targanta Press Release September 19, 2007 Archived July 13, 2011, at the Wayback Machine
- ICAAC 2007 Posters: “In Vitro Susceptibility of Genotypically Distinct Clostridium difficile Strains to Oritavancin” and “Activity of Metronidazole, Vancomycin and Oritavancin Against Epidemic Clostridium difficile Spores” / Targanta Press Release September 19, 2007 Archived July 13, 2011, at the Wayback Machine
- ASM 2007 Poster: “Efficacy of Oritavancin in a Murine Model of Bacillus anthracis Spore Inhalation Anthrax” / Targanta Press Release May 24, 2007 Archived July 13, 2011, at the Wayback Machine
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- Yan, Qun, Melissa J. Karau, and Robin Patel. “In Vitro Activity of Oritavancin against Planktonic and Biofilm States of Vancomycin-Susceptible and Vancomycin-Resistant Enterococci.” Diagnostic Microbiology and Infectious Disease 91, no. 4 (August 2018): 348–50. https://doi.org/10.1016/j.diagmicrobio.2018.03.008 Archived 2021-10-25 at the Wayback Machine.
- ICAAC 2003 Late-breaker poster: "Phase III Trial Comparing 3–7 days of Oritavancin vs. 10–14 days of Vancomycin/Cephalexin in the Treatment of Patients with Complicated Skin and Skin Structure Infections (cSSSI)" / InterMune Press Release September 15, 2003
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