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?
A recent paper by Thabit describes a curious finding . The authors measured total and free (i.e., nonprotein-bound) eravacycline levels at ascending doses in a mouse model. They found strikingly small increases in free drug levels when titrating up total doses. The Continue reading Timely New Information on Next-Generation Tetracyclines – Part 2: Eravacycline and Protein Binding
Since the beginning of this millennium we have seen antibiotic R&D dwindle year after year. There are many reasons for this; while economics are often cited for this decline, the FDA and the ‘Guideline Wars’, i.e., those never ending discussions Continue reading Progress Report: New Antibacterials In the Fight against MDR Bacteria
Whatever has become of investigative journalism? All we read after the Stifel conference call (11/17/2015) is descriptive rehash of information provided by Tetraphase at the conference. No probing questions that we thought investors would ask who just lost 80% of Continue reading Eravacycline Conference Call: Unrevealing and Disappointing
When a well-designed pivotal Phase 3 trial fails to show NI, it demands an explanation. While awaiting the company’s analysis of the data, many possible explanations are bandied about. So it was not surprising that the eravacycline cUTI study (IGNITE-2) Continue reading After ICAAC: Some More Thoughts on Eravacycline in cUTI and IGNITE-2
SH: My dear Watson, did you read the news of the astonishing debacle that befell Mme Erava and made the headlines, creating anxiety of hitherto unknown proportions in Tetraland? Dr.W.: A disaster of epic proportions, for sure, and a mystery, Continue reading Mme Erava and The Mysterious Case of Auto-Combustion
On Feb 25, 2015 the combination of ceftazidime/avibactam (Avycaz) was approved by FDA for cUTI and cIAI infections in patients ‘who have limited or no alternative treatment options’. As a QIDP drug, Avycaz received priority review. Its label states that it is Continue reading Avycaz Approval and Labeling Restrictions
It is no secret that most existing antibiotic guidelines are not getting much use these days. The only indications pursued with any regularity are the feasible ones: ABSSSI, cUTI, and cIAI, much less CABP. Yes, the occasional HABP/VABP trial is Continue reading Most Anti-Infective Guidelines Don’t Get No Respect (Let Alone Use!)
..when it comes to FDA review of antibiotic NDAs. Some seem to have forgotten the dismal record of antibiotic approvals in the last 15 years, and the long list of failed submissions. Many failed not because of lack of efficacy Continue reading No Such Thing as a Free Ride…
Sometimes an article pops up addressing a question we have been mulling over for quite some time. It so happened with a recent publication which shed new light on penem dosing for ICU patients. Conducted at a single Belgian centre Continue reading Meropenem Dosing for VAP: High + Prolonged Beats Conventional Dosing
Solomkin et al. conclude that the efficacy and safety of eravacycline compares favorably to the control drug, ertapenem. This top-level assessment is made with the usual caveats (insufficient statistical power, small sample size), but a few points deserve comment. Eravacycline Continue reading Some Thoughts about Eravacycline Based on the Phase 2 cIAI Study
There are currently a total of 6 beta-lactam + beta-lactamase inhibitor combinations in clinical trials. It will be a steep learning curve for the pharma reps (and physicians) to understand the resistance classifications, the confusing ESBL definitions, the CRE nomenclature, Continue reading What is the “Niche” for Ceftolozane / Tazobactam?