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?

Antibiotic Inhalers Galore (Part 1):  More Combinations and Permutations than a Rubik’s Cube

There is much interest in inhaled antibiotics these days.  Prima facie, the logic for this approach is compelling: Getting the antibiotic (and a lot of it) directly to the site of infection, while avoiding systemic toxicity, sounds like optimized efficacy Continue reading Antibiotic Inhalers Galore (Part 1):  More Combinations and Permutations than a Rubik’s Cube

Food for Thought, Sprinkled With Small Amounts of Antibiotic Residues

80% of antibiotics worldwide are used in veterinary medicine. With only a minor fraction metabolized to inactive compounds, there are plenty of antibiotics excreted by farm animals in unchanged active form. These antibiotic residues are found in manure, in the Continue reading Food for Thought, Sprinkled With Small Amounts of Antibiotic Residues

The FDA AMDAC on Fluoroquinolones (Part 2): Where Were the FQ Advocates?

Any FDA meeting is a high-stakes game for industry:  One never knows how the discussions will go. Some oddball issue may take center stage and usurp much time, creating an unbalanced perspective.  At other times, simple issues seem to create Continue reading The FDA AMDAC on Fluoroquinolones (Part 2): Where Were the FQ Advocates?

AMDAC November 5, 2015 on Fluoroquinolones in ABS, ABECB, uUTI  – Part 1

Only now, a few days before the actual AMDAC meeting, the FDA’s Briefing Document becomes available to the public.  The topic of the December 5th meeting:  Reappraisal of the risk/benefit of fluoroquinolones (FQ) in approved but “mild, self-limiting” disease indications in Continue reading AMDAC November 5, 2015 on Fluoroquinolones in ABS, ABECB, uUTI  – Part 1

MRSA Fluoroquinolones – An Interesting Bunch Playing a High-Stakes Game

Fluoroquinolones (FQ) of the ofloxacin/ciprofloxacin generation were mainly active against Gram-negative bacteria, distinguishing themselves as cidal IV/PO drugs with high potency against most lactose- and non-lactose fermenters.  They were excellent against problem pathogens like P. aeruginosa, had excellent efficacy against Salmonellae, the Gonococcus Continue reading MRSA Fluoroquinolones – An Interesting Bunch Playing a High-Stakes Game

QIDP Drugs – 4th Edition

>>> For the latest QIDP list, please click HERE  <<< Since our last QIDP blog from April 8, 2015, several new drugs have made the list which now includes 41 compounds. Below a table which includes compound, sponsor and development stage (Phase). It Continue reading QIDP Drugs – 4th Edition

Why Moxifloxacin’s Approval for Plague Is So Disturbing

PLEASE SHARE YOUR OPINION AND VOTE BELOW On May 8th, 2015 moxifloxacin/Avelox was approved for treatment of inhalational plague.[1]   We learn that the approval followed the ‘animal rule’ process, and that treatment with moxifloxacin was 100% effective in the African Green Continue reading Why Moxifloxacin’s Approval for Plague Is So Disturbing

Treating GC in the Face of Dwindling Antibiotic Options – (1)

Looking across the Northern border it is clear that CDC Guidelines are not universally followed even in North America.  Public Health Canada still recommends cefixime for uncomplicated gonorrhea (GC), albeit at the high single oral dose of 800 mg[1].   In Continue reading Treating GC in the Face of Dwindling Antibiotic Options – (1)

An Inconvenient Truth: Ciprofloxacin-Resistant Campylobacter

When Al Gore became a best-selling author with “An Inconvenient Truth” he warned about climate change.  When it comes to antibiotic resistance and the current situation of “Bad Bugs, No Drugs”, there are many voices warning us about a return Continue reading An Inconvenient Truth: Ciprofloxacin-Resistant Campylobacter

Aerosolized Antibiotics & Selling Nebulizers

“The medicine comes for free, just pay us for the inhaler” should be the marketing slogan for this group of therapeutics.  Nebulizers are good business: hard to copy as a delivery system, they are a great opportunity to ‘evergreen’ off-patent Continue reading Aerosolized Antibiotics & Selling Nebulizers

A GO / NO GO decision:  Delafloxacin Stumbles in Gonorrhea Study

The treatment history of N. gonorrhoeae makes for fascinating reading.  This organism has always been able to keep the upper hand in the war of bug versus drug.  Once susceptible to sulfa drugs, to penicillin, tetracyclines and fluoroquinolones, it sequentially Continue reading A GO / NO GO decision:  Delafloxacin Stumbles in Gonorrhea Study

The Futile Quest of Proofing a Negative in the Presence of Overwhelming Absence of Harm

The cartilage damage caused by fluoroquinolones in juvenile beagle dogs is not subtle:  blister formation and erosions occur in a dose-dependent fashion resulting in reversible cartilage damage.  These lesions can be seen not just histologically but even macroscopically.  The animals Continue reading The Futile Quest of Proofing a Negative in the Presence of Overwhelming Absence of Harm

What is the “Niche” for Ceftolozane / Tazobactam?

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?

The Breakpoint Dilemma

As antibiotic resistance increases over the years, originally established susceptibility breakpoints (S-I-R) are becoming less relevant.   This ‘creep’ towards higher MICs over time is a unique but well-known feature of antimicrobials ultimately making these drugs obsolete. In the past, Continue reading The Breakpoint Dilemma