Prakt. Lékáren. 2017; 13(1e) [Klin Farmakol Farm. 2016;30(3):23-28]

New antibiotics in the clinical practise and in the clinical trials

Lenka Součková1, 2, 4, 5, Adriana Ruzsíková2, 3
1 Masarykova Univerzita, Lékařská fakulta, Farmakologický ústav
2 Fakultní nemocnice u sv. Anny v Brně, ICRC
3 Masarykova Univerzita, Lékařská fakulta, Anesteziologicko-resuscitační klinika
4 Fakultní nemocnice Brno, Klinika dětské onkologie
5 Masarykův onkologický ústav

Expanding of resistance of still susceptible strains of bacteria to antibiotics, associated with the increasing consumption of antibiotics in bothhuman and veterinary medicine, is occurring faster than the marketing approvals and the implementation of new antibiotic molecules to clinicalpractice. The development of new antibiotic molecules is troublesome, expensive and timeconsuming. Inspite of this, 30 new antibioticmolecules were registered in the last 15 years and more than 10 molecules are in the process of phase III clinical trials. Therefore we can expect further new marketing approvals in the field of antimicrobial drugs in the upcoming years. The article briefly describes the new antibioticsapproved since 2000. This review also summarizes the current status of clinical research in the field of antibiotics.

Keywords: new antibiotics, research and development of drugs, marketing approval, resistance

Published: April 1, 2017  Show citation

ACS AIP APA ASA Harvard Chicago Chicago Notes IEEE ISO690 MLA NLM Turabian Vancouver
Součková L, Ruzsíková A. New antibiotics in the clinical practise and in the clinical trials. Praktické lékárenství. 2017;13(E-verze 1/17):.
Download citation

References

  1. Fleming A. On the antibacterial action of cultures of a penicillium, with special reference to their use in the isolation of B. influenzae. Br J Exp Path, X (1929), pp. 3-13.
  2. Schatz A, Bugie E, Waksman SA. Streptomycin, a substance exhibiting antibiotic activity against gram-positive and gram-negative bacteria. Proc. Soc. Exp. Biol. Med. 1944; 55: 66-69. Go to original source...
  3. Kardos N, Demain AL. Penicillin: the medicine with the greatest impact on therapeutic outcomes. Appl. Microbiol. Biotechnol. 2011; 92: 677-687. Go to original source... Go to PubMed...
  4. Tallman G, Brock J. Pipeline or pipe dream: New antibiotics for
  5. multidrug-resistant gram-negative bacilli. Infectious Disease News, 2013; 26: 40.
  6. Spellberg B, Shlaes D. Prioritized current unmet needs for antibacterial therapies. Clin. Pharmacol. Ther. 2014; 96: 151-153. Go to original source... Go to PubMed...
  7. Hesterkamp T. Antibiotics Clinical Development and Pipeline. Curr Top Microbiol Immunol. 2015; Epub 2015 Jul 11. Go to original source... Go to PubMed...
  8. Cooper MA, Shlaes D. Fix the antibiotics pipeline. Nature. 2011; 472: 32. Go to original source... Go to PubMed...
  9. So AD. Towards new business models for R & D for novel antibiotics. Drug Resist. Updates. 2011; 14: 88-94. Go to original source... Go to PubMed...
  10. Boucher HW. 10 × '20 Progress-Development of new drugs active agains gram negative bacilli: an update from the Infectious Disease of America. Clin Infect Dis. 2013; 56: 1685-1694. Go to original source... Go to PubMed...
  11. Butler MS, Blaskovich MA, Cooper MA. Antibiotics in the clinical pipeline in 2013. The Journal of antibiotics. 2013; 66: 571-591. Go to original source... Go to PubMed...
  12. Zyvoxid(R) SPC, file:///D:/Users/270934/Downloads/zyvoxid-2-mg-ml-infuzni-roztok-spc%20(1).pdf, staženo 8. 4. 2016.
  13. Sivextro(R) SPC, http://www.ema.europa.eu/docs/cs_CZ/document_library/EPAR_-_Product_Information/human/002846/WC500184802.pdf, staženo 6. 4. 2016.
  14. Hayden MK, Reyai K. Development of Daptomycin Resistance in vivo in methicillin-resistant Staphylococcus aureus. J Clin Microb. 2005; 23: 5285-5287. Go to original source... Go to PubMed...
  15. Cubicin(R) SPC, http://www.ema.europa.eu/docs/cs_CZ/document_library/EPAR_-_Product_Information/human/000637/WC500036049.pdf, staženo 6. 4. 2016.
  16. Altargo(R) SPC, http://www.ema.europa.eu/docs/cs_CZ/document_library/EPAR_-_Product_Information/human/000757/WC500024409.pdf.
  17. Lonks JR, Goldmann DA. Telithromycin: A Ketolide Antibiotic for Treatment of Respiratory Tract Infections. Clin Infect Dis. 2005; 40: 1657-1664. Go to original source... Go to PubMed...
  18. Ketek(R) SPC, http://www.ema.europa.eu/docs/cs_CZ/document_library/EPAR_-_Product_Information/human/000354/WC500041895.pdf, staženo 6. 4. 2016.
  19. Dificlir(R) SPC, http://www.ema.europa.eu/docs/cs_CZ/document_library/EPAR_-_Product_Information/human/002087/WC500119705.pdf, staženo 6. 4. 2016.
  20. Tupin A. The transcription inhibitor lipiarmycin blocks DNA fitting into RNA polymerase catalytic site. EMBOJ. 2010; 29: 2527-2537. Go to original source... Go to PubMed...
  21. Haagsma AC. Selectivity of TMC207 towards mycobacterial ATP synthase compared with thst towards the eucaryotic homologue. Antimicrob. Agents Chemother. 2009; 53: 1290-1292. Go to original source... Go to PubMed...
  22. Sirturo(R) SPC, http://www.ema.europa.eu/docs/cs_CZ/document_library/EPAR_-_Product_Information/human/002614/WC500163209.pdf, staženo 6. 4. 2016.
  23. Tisková zpráva z 30. 4. 2014 Otsuka Wins European Marketing Authorization for Deltyba(TM) (delamanid), http://www.businesswire.com/news/home/20140429006457/en/Otsuka-Wins-European-Marketing-Authorization-Deltyba%E2%84%A2-delamanid#.Vdcfxmcw9aR, staženo 21. 9. 2015.
  24. Deltyba(R) SPC, http://www.ema.europa.eu/docs/cs_CZ/document_library/EPAR_-_Product_Information/human/002552/WC500166232.pdf, staženo 6. 4. 2016.
  25. Allington DR. Quinupristin/dalfopristin: a therapeutic review. Clinical Therapeutics. 2001; 23: 24-44. Go to original source... Go to PubMed...
  26. Synercid(R) SPC, http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050748s008,050747s008lbl.pdf, staženo 6. 4. 2016.
  27. Zeftera(R) SPC, http://www.mhra.gov.uk/home/groups/spcpil/documents/spcpil/con1448606619300.pdf, staženo 6. 4. 2016.
  28. Tisková zpráva z 24. 6. 2010 - zamítnutí registrace přípravku Zeftera (ceftobiprol) http://www.ema.europa.eu/docs/cs_CZ/document_library/Summary_of_opinion_-_Initial_authorisation/human/000883/WC500093966.pdf, staženo 19. 11. 2015.
  29. Tisková zpráva, http://www.basilea.com/chameleon/public/584f9d1e-4298-e47c-0475-a5e5e5288ded/582542, staženo 6. 4. 2016.
  30. Tisková zpráva z 25. 2. 2015 Actavis Receives U.S. FDA Approval for AVYCAZ(TM) (CEFTAZIDIME-AVIBACTAM) http://www.actavis.com/news/news/thomson-reuters/actavis-receives-u-s-fda-approval-for-avycaz-ceft. (staženo 6. 6. 2015).
  31. Durata Therapeutics Announces Preliminary, Topline Phase 3 clinical trial Results for Dalbavancin in the treatment of ABSSSI (Press release 25 February 2013) http://www.duratatherapeutics.com/news-media/press-releases/detail/7914/durata-therapeutics-announces-preliminary-topline-phase-3, staženo 21. 8. 2015.
  32. Bouza E. Oritavancin: a novel lipoglycopeptide active against Gram positive pathogens including multiresistant strains. Int. J. Antimicrob Agents. 2010; 36: 401-407. Go to original source... Go to PubMed...
  33. Nannini EC. Telavancin for the treatment of hospital-acquired pneumonia: findings from the ATTAIN studies. Expert Rev Anti Infect Ther. 2012; 10: 847-854. Go to original source... Go to PubMed...
  34. Unidrox(R) SPC, http://www.sukl.cz/download/spc/SPC9418.pdf.
  35. Furiex Receives Qualified Infectious Disease Product and Fast Track Designations from the U.S. Food and Drug Administration for Avarofloxacin (JNJ-Q2) (press release 25. 2. 2015) http://www.businesswire.com/news/home/20130225006680/en/Furiex-Receives-Qualified-Infectious-Disease-Product-Fast, staženo 21. 8. 2015.
  36. Tisková zpráva TOYAMA CHEMICAL CO., LTD., https://www.toyama-chemical.co.jp/eng/news/news1004e.html, staženo 6. 4. 2016.
  37. Poole RM. Nemonoxacin: first global approval. Drugs. 2014; 74: 1445-1453. Go to original source... Go to PubMed...
  38. Nýč O. Potřeba a perspektivy nových antibiotik. Remedia. 2007; 5: 476-480.
  39. Wang X, et al. Biapenem versus meropenem in the treatment of bacterial infections: a multicenter, randomized, controlled clinical trial. Indian J Med Res. 2013; 138(6): 995-1002.
  40. Tygacil(R) SPC, http://www.sukl.cz/modules/medication/detail.php?code=0026127&tab=texts, staženo 6. 4. 2016.
  41. Tetraphase Pharmaceuticals. FDA Awards Fast Track Status to Tetraphase Pharmaceuticals for IV and Oral Formulations of Eravacycline. (Press release, 2 April, 2014) http://ir.tphase.com/releasedetail.cfm?ReleaseID=837185 staženo 6. 4. 2016.
  42. Waites KB, Crabb DM, Duffy LB. Comparative In Vitro Susceptibilities of Human Mycoplasmas and Ureaplasmas to a New Investigational Ketolide, CEM-101 Antimicrobial Agents and Chemotherapy. 2009; 53: 2139-2141. Go to original source... Go to PubMed...
  43. Shlaes DM, Spellberg B. Overcoming the challenges to developing new antibiotics. Curr. Opin. Pharmacol. 2012; 112: 522-526. Go to original source... Go to PubMed...
  44. Nichols D, Cahoon N, Trakhtenberg EM, et al. Use of ichip for high-throughput in situ cultivation of "uncultivable" microbial species". Appl. Environ. Microbiol. 2010; 76: 2445-2450. Go to original source... Go to PubMed...
  45. Losee LL, et al. A new antibiotic kills pathogens without detectable resistance. Nature. 2015; 517: 455-459. Go to original source... Go to PubMed...




Pharmacy for Practice

Madam, Sir,
please be aware that the website on which you intend to enter, not the general public because it contains technical information about medicines, including advertisements relating to medicinal products. This information and communication professionals are solely under §2 of the Act n.40/1995 Coll. Is active persons authorized to prescribe or supply (hereinafter expert).
Take note that if you are not an expert, you run the risk of danger to their health or the health of other persons, if you the obtained information improperly understood or interpreted, and especially advertising which may be part of this site, or whether you used it for self-diagnosis or medical treatment, whether in relation to each other in person or in relation to others.

I declare:

  1. that I have met the above instruction
  2. I'm an expert within the meaning of the Act n.40/1995 Coll. the regulation of advertising, as amended, and I am aware of the risks that would be a person other than the expert input to these sites exhibited


No

Yes

If your statement is not true, please be aware
that brings the risk of danger to their health or the health of others.