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

QIDP Drug Update – Part 1: An Updated Who Is Who

It is time for a new look at the field of QIDP drugs. Today we are providing an updated searchable database which now has 57 entries. (Status: 10/18/16) Despite best efforts to provide accurate information, errors may have crept in. Please let us Continue reading QIDP Drug Update – Part 1: An Updated Who Is Who

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?

Aztreonam PLUS Avibactam – A New Bright Star in the Night Sky

Looking at the molecular structure of ceftazidime (CTAZ) and aztreonam (ATM), the differences are clear, and so are the similarities: ATM does not have the cephem ring structure of CTAZ, only the 4-member beta-lactam ring.  However, the side chains are Continue reading Aztreonam PLUS Avibactam – A New Bright Star in the Night Sky

Ibuprofen For uUTI: Interesting Pilot Trial But More to Come Soon

At the recent AMDAC, the frequent mention of an unusual uUTI study caught my attention.  In their review of placebo-controlled trials, FDA mentioned a study comparing ciprofloxacin with Ibuprofen (Motrin), an NSAID drug without any antibacterial activity[1].  By the outcome Continue reading Ibuprofen For uUTI: Interesting Pilot Trial But More to Come Soon

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

ALLPHASE PHARMA – THE FIRST 100 BLOG POSTS

After the first 100 blogs, it is appropriate to reflect on reader preferences.  When I arbitrarily select a topic, it is not always clear whether what interests me also interests you. Since its start 1½ years ago, this blog has grown Continue reading ALLPHASE PHARMA – THE FIRST 100 BLOG POSTS

Streptomyces – The Industrious Antibiotic Producer

Like other actinomycetes, the Streptomyces group of microbes straddles the somewhat artificial boundary between bacteria and fungi. Growth on culture plates looks ‘fungal’ and the organism produces spores and germtubes that look like mycelia.  Nonetheless these soil organisms are bacteria and of Continue reading Streptomyces – The Industrious Antibiotic Producer

Nitrofurantoin – An Old Drug Resurrected Needs Prospective Scrutiny

When older drugs get reintroduced into clinical practice because pathogens have developed resistance to newer agents, it comes at the price of uncertainty. Often, older drugs were approved based on rather limited data, often considered incomplete by today’s standards.  Take colistin Continue reading Nitrofurantoin – An Old Drug Resurrected Needs Prospective Scrutiny

A Renaissance for Old Drugs: Fosfomycin and Colistin

Fosfomycin Who would have thought that a drug that has been around since 1969 [2] could become eligible for QIDP status in 2015? Well, Zavante Therapeutics recently garnered the coveted QIDP designation for fosfomycin IV. This formulation has been available Continue reading A Renaissance for Old Drugs: Fosfomycin and Colistin

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