Sulopenem uUTI – Does It Suffice?

Sulopenem / ORLYNVAH approved for uUTI When Iterum, a Pfizer spin-off of sorts, took over sulopenem development in 2015, there was still hope for approvals of this drug in multiple indications such as uUTI, cUTI, cIAI and even CABP.  Ten Continue reading Sulopenem uUTI – Does It Suffice?

BLUJEPA / Gepotidacin APPROVED FOR UNCOMPLICATED UTI – 1

GSK’s pipeline in anti-infectives is impressive. It comprises drugs for bacterial, mycobacterial, fungal, viral infections, and for malaria; in addition, they have a number of vaccines in development.  Several antibiotics are listed on their website targeting UTI pathogens, and one Continue reading BLUJEPA / Gepotidacin APPROVED FOR UNCOMPLICATED UTI – 1

Gepotidacin ABSSSI – How to Fail Adaptively

Study Design in ABSSSI – A Statistician’s Delight The design of the O’Riordan ABSSI study [1] deserves comment.  This was a double-blind study of 2 lower dose arms (Part 1) with an add-on open-label (Part 2) high-dose arm. The pimary Continue reading Gepotidacin ABSSSI – How to Fail Adaptively

Efficacy and Treatment Duration: Where is the Tipping Point?

Development pf antibacterials differs in several important ways from drug development in other areas, and the lack of standard dose-finding is just one of them. Dose-finding in its most basic form involves ascending amounts of drug for efficacy and safety; Continue reading Efficacy and Treatment Duration: Where is the Tipping Point?

Ibuprofen for uUTI (Part 2): Antibiotic or NSAID? Or Both? Or Neither?

While the news is abuzz with reports of Zika virus coming to a place near you, an interesting article on a much more mundane topic – the treatment of uncomplicated UTIs – should be competing for your attention. It is a publication we Continue reading Ibuprofen for uUTI (Part 2): Antibiotic or NSAID? Or Both? Or Neither?