Pradalex (pradofloxacin injection): A new era in BRD treatment
Introducing Pradalex (pradofloxacin injection), the first FDA-approved injectable antibiotic with a new active ingredient for BRD in years
January 1, 2025
Author: Elanco (Beef Cattle Technical Consultant - Ronald K. Tessman, DVM, PhD, DACVIM, DACVPM)
For over a decade, cattle producers have relied on the same options for treating bovine respiratory disease (BRD). Now, there's a breakthrough: PradalexTM (pradofloxacin injection), the first FDA-approved injectable antibiotic with a new active ingredient for BRD in years. Pradalex isn't just another fluoroquinolone—it's a third-generation innovation offering unique and beneficial features that are improvements over older alternatives1,2.
Elanco developed Pradalex to address the critical need for new, effective antibiotics in the face of growing antimicrobial resistance. This commitment to innovation is part of a broader effort to ensure responsible and sustainable antibiotic use.
BRD is a complex disease.
More than 50% of BRD mortalities may be due to mixed infections.3 BRD has a fast disease progression, making bacterial isolation and sensitivity testing not practical in an outbreak. For all these reasons, it’s vital to use an antibiotic that is highly efficacious against all four common BRD bacteria, including M. bovis.
Unlike antimicrobials with other active ingredients, Pradalex demonstrated proven clinical effectiveness against all four major BRD pathogens, including M. bovis, in a single multi-site field trial, not requiring follow-up trials conducted specifically for demonstrating M. bovis effectiveness.4
The key differentiator of Pradalex lies in its unique dual mode of action. Unlike second-generation fluoroquinolones, Pradalex targets two sites of DNA replication within the same bacteria with equal affinity. This means faster, more potent bacterial kill, impacting both resting and actively growing bacterial populations.5,6 In fact, Pradalex is the most potent fluoroquinolone available, achieving almost three times the concentration of enrofloxacin less than an hour after injection.7
This enhanced potency translates to superior in-vitro efficacy against all relevant BRD pathogens, including Mycoplasma bovis. Following subcutaneous injections, Pradalex is rapidly absorbed and distributed, reaching effective concentrations and beginning to eliminate bacteria within just 5 minutes. Peak concentrations in plasma occur in 45 minutes, interstitial fluid in less than 90 minutes, and pulmonary epithelial lining fluid in less than 7.5 hours.
Pradalex offers practical benefits for producers.
Its convenient single-dose, low-volume formulation (2.3mL/100 lbs bw) ensures easy administration, even in challenging handling situations, and boasts exceptional syringeability. Furthermore, Pradalex has a short, 4-day withdrawal period.
The rapid elimination of Pradalex from the body contributes to its reduced impact on the microbiome and minimizes the opportunity for resistance development.1,7 Its optimized pharmacokinetic profile reduces the time within the Mutant Selection Window (MSW) to less than 9 hours. As a concentration-dependent antibiotic—unlike time-dependent antibiotics—Pradalex rapidly reaches peak concentrations above the MIC and MPC, swiftly eliminating bacteria, including strains with first step mutations for resistance, before they can replicate. This targeted approach requires less time in the animal's system, further reducing the risk of resistance development. Pradofloxacin, the active ingredient in Pradalex, is primarily excreted unchanged in the urine.8
Ask your veterinarian or Elanco representative about Pradalex or visit Pradalex.com for more information.
About the Author
Dr. Ronald Tessman is a Beef Cattle Technical Consultant for Elanco Animal Health based out of Kansas City, Missouri, supporting feedyard producers. He earned his Doctor of Veterinary Medicine from Washington State University and a doctorate degree in veterinary pathobiology from the University of Missouri.
He has more than 17 years of experience and his career has included roles at Bayer Animal Health and Merial where he oversaw clinical efficacy studies crucial for the development of animal health products for farm animals. He also serves as an adjunct assistant professor at the University of Missouri College of Veterinary Medicine.
Today, Dr. Tessman's role at Elanco Animal Health allows him to apply his wealth of knowledge and experience to the betterment of beef cattle production, supporting feedyard producers in Kansas City and beyond. His dedication to research, education and the development of animal health solutions continues to drive innovation and progress in the beef industry.
References
Blondeau, J.M.; Fitch, S.D. Comparative In Vitro Killing by Pradofloxacin in Comparison to Ceftiofur, Enrofloxacin, Florfenicol, Marbofloxacin, Tildipirosin, Tilmicosin and Tulathromycin against Bovine Respiratory Bacterial Pathogens. Microorganisms 2024, 12,996. https://doi.org/10.3390/microorganisms12050996
Blondeau, J.M.; Fitch, S.D. Comparative Minimum Inhibitory and Mutant Prevention Drug Concentrations for Pradofloxacin and Seven Other Antimicrobial Agents Tested against Bovine Isolates of Mannheimia haemolytica and Pasteurella multocida. Pathogens 2024, 13, 399. https://doi.org/10.3390/pathogens13050399
Murray GM, More SJ, Sammin D, et al. Pathogens, patterns of pneumonia, and epidemiologic risk factors associated with respiratory disease in recently weaned cattle in Ireland. J. Vet. Diagn. Invest., 2017:29(1):20–34.
US Food and Drug Administration. Original New Animal Drug Application for Pradalex. NADA-141-550. US Department of Health and Human Services; April 9th, 2024. Unpublished FOIA response.
Wetzstein HG, DeJong A. In vitro bactericidal activity and PAE of fluoroquinolones used in veterinary medicine. Second International Veterinary Symposium on Baytril. Proceedings. Compend Contin Educ Pract Vet. 1996:18(2):22-29.
Claus GW, Carter GR, Chengappa MM, Roberts AW. Microbial nutrition, metabolism, and growth. Essentials of Veterinary Microbiology. 1995:39.
Elanco Animal Health. Data on File.
Links: Pradalex: https://farmanimal.elanco.com/us/campaign/pradalex
Important Safety Information:
Available by prescription only. Not for use in humans. Not for use in animals intended for breeding because the effects of Pradalex on reproductive performance, pregnancy, and lactation have not been determined. See pack insert for product indication and full safety information.
Pradalex, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates. Other product names are trademarks of their respective owners.
©2024 Elanco or its affiliates. PM-US-24-2067
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