Finafloxacin: First global approval

Drugs

Volumn 75, Issue 6, 2015, Pages 687-693

  McKeage, Kate ^a  

^a Springer ^*  (New Zealand)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIINFECTIVE AGENT; FINAFLOXACIN; QUINOLONE DERIVATIVE;

ANIMAL; DRUG APPROVAL; DRUG EFFECTS; HELICOBACTER PYLORI; HUMAN; INTERNATIONAL COOPERATION; MICROBIAL SENSITIVITY TEST; OTITIS EXTERNA; URINARY TRACT INFECTIONS;

ANIMALS; ANTI-BACTERIAL AGENTS; DRUG APPROVAL; FLUOROQUINOLONES; HELICOBACTER PYLORI; HUMANS; INTERNATIONALITY; MICROBIAL SENSITIVITY TESTS; OTITIS EXTERNA; URINARY TRACT INFECTIONS;

EID: 84939990273     PISSN: 00126667     EISSN: 11791950     Source Type: Journal    
DOI: 10.1007/s40265-015-0384-z     Document Type: Article

References (24)

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.