Skip to main content
SpringerLink
Log in

Finafloxacin: First Global Approval

  • R&D Insight Report
  • Published:
Drugs Aims and scope Submit manuscript

Abstract

Finafloxacin is a fluoroquinolone antimicrobial agent that exhibits optimum efficacy in slightly acidic environments. It is being developed by MerLion Pharmaceuticals to treat serious bacterial infections associated with an acidic environment, including urinary tract infections and Helicobacter pylori infections. An otic suspension of finafloxacin (Xtoro™), developed by Alcon (a division of Novartis), was recently approved in the USA for the treatment of acute otitis externa, and a Common Technical Document for this indication was also filed in Canada. Oral and/or intravenous formulations are in phase I and II evaluation in uncomplicated urinary tract infections (Germany and Singapore), complicated urinary tract infections and pyelonephritis (Germany and Poland) and H. pylori infection (Germany). This article summarizes the milestones in the development of finafloxacin leading to this first approval for otitis externa.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. MerLion Pharmaceuticals Pte Ltd. MerLion signs license agreement with Alcon to develop and commercialize novel finafloxacin otic product [media release]. 11 Jan 2011. http://www.merlionpharma.com.

  2. MerLion Pharmaceuticals Pte Ltd. MerLion Pharmaceuticals Pte Ltd receives IND Approval from the FDA for finafloxacin; a novel ‘pH activated’ antibiotic. Media Release. 2009.

  3. U.S. Food and Drug Administration. FDA approves Xtoro to treat swimmer’s ear [media release]. 19 Dec 2014. http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm427274.htm.

  4. Alcon. Alcon and Novartis complete merger and form new Alcon Division to accelerate global leadership in eye care [media release]. 8 Apr 2011. http://www.alcon.com.

  5. Alcon Laboratories Inc. Prescribing Information: Xtoro (finafloxacin otic suspension). 2014. http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206307s000lbl.pdf. Accessed 24 Feb 2015.

  6. Emrich NC, Heisig A, Stubbings W, et al. Antibacterial activity of finafloxacin under different pH conditions against isogenic strains of Escherichia coli expressing combinations of defined mechanisms of fluoroquinolone resistance. J Antimicrob Chemother. 2010;65(12):2530–3.

    Article  CAS  PubMed  Google Scholar 

  7. Genzel GH, Stubbings W, Stîngu CS, et al. Activity of the investigational fluoroquinolone finafloxacin and seven other antimicrobial agents against 114 obligately anaerobic bacteria. Int J Antimicrob Agents. 2014;44(5):420–3.

    Article  CAS  PubMed  Google Scholar 

  8. Idelevich EA, Kriegeskorte A, Stubbings W, et al. Comparative in vitro activity of finafloxacin against staphylococci displaying normal and small colony variant phenotypes. J Antimicrob Chemother. 2011;66(12):2809–13.

    Article  CAS  PubMed  Google Scholar 

  9. Dalhoff A, Stubbings W, Schubert S. Comparative in vitro activities of the novel antibacterial finafloxacin against selected Gram-positive and Gram-negative bacteria tested in Mueller-Hinton broth and synthetic urine. Antimicrob Agents Chemother. 2011;55(4):1814–8.

    Article  PubMed Central  CAS  PubMed  Google Scholar 

  10. Higgins PG, Stubbings W, Wisplinghoff H, et al. Activity of the investigational fluoroquinolone finafloxacin against ciprofloxacin-sensitive and -resistant Acinetobacter baumannii isolates. Antimicrob Agents Chemother. 2010;54(4):1613–5.

    Article  PubMed Central  CAS  PubMed  Google Scholar 

  11. Goh CY, Ng SB, Everett MJ. Comparison of postantibiotic effects of finafloxacin and other fluoroquinolones [abstract no. A-1959]. In: 52nd Interscience Conference on Antimicrobial Agents and Chemotherapy; 12 Sep 2012; San Francisco, CA.

  12. Lemaire S, Van Bambeke F, Tulkens PM. Activity of finafloxacin, a novel fluoroquinolone with increased activity at acid pH, towards extracellular and intracellular Staphylococcus aureus, Listeria monocytogenes and Legionella pneumophila. Int J Antimicrob Agents. 2011;38(1):52–9.

    Article  CAS  PubMed  Google Scholar 

  13. Stubbings W, Leow P, Yong GC, et al. In vitro spectrum of activity of finafloxacin, a novel, pH-activated fluoroquinolone, under standard and acidic conditions. Antimicrob Agents Chemother. 2011;55(9):4394–7.

    Article  PubMed Central  CAS  PubMed  Google Scholar 

  14. Wagenlehner FM, Wagenlehner CM, Blenk B, et al. Urinary pharmacokinetics and bactericidal activity of finafloxacin (200 and 800 mg) in healthy volunteers receiving a single oral dose. Chemotherapy. 2011;57(2):97–107.

    Article  CAS  PubMed  Google Scholar 

  15. Barnes K, Harding SV, Richards M, et al. In vitro evaluation of the novel fluoroquinolone finafloxacin against Yersinia pestis [abstract no. P0241]. In: 24th European Society of Clinical Microbiology and Infectious Diseases; 10 May 2014; Barcelona, Spain.

  16. Morrissey I, Hawser S, Vente A, et al. Efficacy of the investigational fluoroquinolone finafloxacin against resistant staphylococci as compared to ciprofloxacin, levofloxacin, and moxifloxacin [abstract no. P1669]. In: 24th European Society of Clinical Microbiology and Infectious Diseases; 13 May 2014; Barcelona, Spain.

  17. Harding S, Barnes K, Simpson A, et al. Efficacy of the investigational fluoroquinolone finafloxacin in a murine inhalational model of melioidosis [abstract no. P0110]. In: 24th European Society of Clinical Microbiology and Infectious Diseases; 10 May 2014; Barcelona, Spain.

  18. Kim N, Lee JW, Nam RH, et al. Antibiotic activity of finafloxacin on Helicobacter pylori isolates depending on pH value comparing with other fluoroquinolone in Korea [abstract no. Su1178]. Gastroenterology. 2014;146(5 Suppl 1):S-396.

  19. Goh CY, Goh F, Stubbings W, et al. Bactericidal activity of finafloxacin (FIN) against difficult to kill growth forms of Escherichia coli [abstract no. F1-2042 plus poster]. In: 48th ICAAC/46th IDSA; 2008.

  20. Patel H, Andresen A, Vente A, et al. Human pharmacokinetics and safety profile of finafloxacin, a new fluoroquinolone antibiotic, in healthy volunteers. Antimicrob Agents Chemother. 2011;55(9):4386–93.

    Article  PubMed Central  CAS  PubMed  Google Scholar 

  21. Luckermann M, Mooney L, Patel H, et al. A phase I study to determine safety, tolerability and pharmacokinetics (PK) of intravenous doses of finafloxacin HCI (FIN) in healthy subjects [abstract no. A-1960]. In: 52nd Interscience Conference on Antimicrobial Agents and Chemotherapy; 12 Sep 2012; San Francisco, CA.

  22. U.S. Food and Drug Administration. FDA clinical review. 2014. http://www.fda.gov/downloads/drugs/developmentapprovalprocess/developmentresources/ucm430946.pdf. Accessed 26 Feb 2015.

  23. MerLion Pharmaceuticals Pte Ltd. Finafloxacin background (phase II cUTI trial and drug characteristics) [media release]. 8 Jan 2015. http://www.merlionpharma.com/?q=node/228.

  24. US National Institutes of Health. ClinicalTrials.gov. 2015. https://clinicaltrials.gov/ct2/show/NCT01928433. Accessed 26 Feb 2015.

Download references

Disclosure

The preparation of this report was not supported by any external funding. During the peer review process, the manufacturer of the agent under review was offered an opportunity to comment on this article. Changes resulting from comments received were made by the author on the basis of scientific and editorial merit. K. McKeage is a salaried employee of Adis/Springer.

Author information

Authors and Affiliations

  1. Springer, Private Bag 65901, Mairangi Bay, 0754, Auckland, New Zealand

    Kate McKeage

Authors
  1. Kate McKeage
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Kate McKeage.

Additional information

This profile has been extracted and modified from the Adis R&D Insight drug pipeline database. Adis R&D Insight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

McKeage, K. Finafloxacin: First Global Approval. Drugs 75, 687–693 (2015). https://doi.org/10.1007/s40265-015-0384-z

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s40265-015-0384-z

Keywords

Search

Navigation