FDA approves oral vancomycin solution for C difficile diarrhea
CutisPharma today announced that the US Food and Drug Administration (FDA) has approved Firvanq, the company's vancomycin oral solution for treating Clostridium difficile–associated diarrhea (CDAD) and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains.
"Firvanq's approval is an important step forward to providing patients the only FDA-approved vancomycin oral liquid treatment option for Clostridium difficile associated diarrhea, a life-threatening condition that affects over a half-million patients in the United States annually," said Neal I. Muni, MD, MSPH, chief executive officer of CutisPharma, which is headquartered in Wilmington, Mass.
The formulation is expected to launch Apr 2, the company said in a news release, at which point it will replace CutisPharma's First-Vancomycin Unit-of-Use Compounding Kit, which has been an option for pharmacists to provide liquid oral therapy for CDAD. Firvanq is designed for ease of use and might be a cost-effective alternative to existing vancomycin therapies, the company said in the release.
"As a practicing infectious disease physician treating many patients with CDAD, having an FDA-approved vancomycin oral liquid formulation that is affordable and accessible to my patients is very beneficial,” said Stuart Johnson, MD, of Loyola University Medical Center, in the news release. "Patient access is currently limited by the fact that only a select few pharmacies perform compounding in the outpatient setting these days, given the many new regulations in place."
Jan 29 CutisPharma news release
Researchers stress importance of including risk factors in UTI prescribing
A single-center German study highlighting risk factors for drug resistance in upper urinary tract infections (UTIs) found that managing patients according to treatment guidelines would have led to incorrect antibiotic prescribing in almost 30% of patients.
Writing in BMC Infectious Diseases, researchers from Heidelberg University in Mannheim identified seven factors associated with antibiotic-resistance UTI infections among 137 patients, including nursing home residence, male gender, recent hospitalization, renal transplantation, and recent antibiotic use. They found that, in patients with two or more risk factors, susceptibility to ciprofloxacin dropped from 90% to 52%, compared with a 98%-to-54% drop for cefuroxime and a 98%-to-61% drop for cefpodoxime.
The investigators found that, of 124 patients with available information, only 80 (64.5%) received an empiric therapy that showed susceptibility to its causing pathogen in urine culture testing. Also, empiric therapy based on current guidelines for upper UTI would have an overall susceptibility of 71.5%. The researchers, however, were able to increase that rate to 86.1% by using an algorithm based on the risk factors they identified.
Using this algorithm, the team determined that, in patients who have no risk factors, cephalosporins seem to be the best choice for empiric therapy, but in patients with risk factors piperacillin with tazobactam is an equal or better choice than fluoroquinolones, cephalosporins, or gentamicin.
The authors concluded, "This study highlights the importance of monitoring local resistance rates and its risk factors in order to improve empiric therapy in a local environment."
Jan 26 BMC Infect Dis study
Study confirms link between high-zinc feed and resistant E coli in swine
German researchers reported in PLoS One that adding high levels of dietary zinc to feed appears to promote the persistence of multidrug-resistant (MDR) Escherichia coli in the gut of pigs.
In some countries high levels of zinc oxide are used as a feed additive to improve gut health and promote growth. And in 2015 a research team from Freie University Berlin showed an increase in MDR E coli tied to zinc feeding in piglets. But that study focused on the clonal diversity of E coli, observing the effect on MDR strains by chance.
In the new study, the researchers separated piglets into a high-zinc group and a "background zinc feeding group" that served as controls. They found that the incidence of MDR E coli increased by 28.9% to 30.2% in the high-zinc group, compared with 5.8% to 14.0% in the control group, even though the total amount of E coli detected in the pigs' guts declined over the study period. The scientists, in fact, determined that the increase in MDR E coli was independent of E coli concentrations and appeared to be linked with persistence of populations of the MDR pathogens.
"In conclusion," they write, "these findings corroborate our previous report linking high dietary zinc feeding of piglets with the occurrence of antimicrobial resistant E. coli and therefore question the feeding of high dietary zinc oxide as alternative to antimicrobial growth promoters."
Jan 26 PLoS One study