Drugs

pp 1–6

Delafloxacin: First Global Approval

AdisInsight Report

Abstract

Delafloxacin (Baxdela™) is a fluoroquinolone antibacterial with activity against both gram-positive and gram-negative pathogens being developed by Melinta Therapeutics. The drug is being investigated or considered as a treatment for various bacterial infections and in June 2017 received approval in the USA for the treatment of acute bacterial skin and skin structure infections. This article summarizes the milestones in the development of delafloxacin leading to this first global approval for the treatment of acute bacterial skin and skin structure infections.

References

  1. 1.
    Melinta Therapeutics. BAXDELA (delafloxacin): US Prescribing Information. 2017. http://www.baxdelarx.com/docs/baxdela-prescribing-information.pdf. Accessed 14 Jul 2017.
  2. 2.
    Melinta Therapeutics. Melinta Therapeutics and Menarini Group enter into commercial and co-development agreement for delafloxacin in 68 countries [media release] 1 Mar 2017. http://www.melinta.com.
  3. 3.
    Melinta Therapeutics. Melinta Therapeutics and Eurofarma Laboratorios enter into commercialization and distribution agreements for delafloxacin in Brazil [media release] 8 Jan 2015. http://www.melinta.com.
  4. 4.
    Huband MD, Streit JM, Shortridge D, et al. In vitro evaluation of delafloxacin activity when tested against contemporary ABSSSI isolates from Europe and surrounding areas (2014–2016): results from the SENTRY antimicrobial surveillance program [abstract no. P1351 plus poster]. In: ECCMID. 2017.Google Scholar
  5. 5.
    Shortridge D, Streit JM, Huband MD, et al. In vitro evaluation of delafloxacin activity when tested against contemporary ABSSSI isolates from the United States (2014–2016): results from the SENTRY antimicrobial surveillance Program [abstract no. Sunday—4]. In: ASM Microbe. 2017.Google Scholar
  6. 6.
    Pfaller MA, Sader HS, Rhomberg PR, et al. In vitro activity of delafloxacin against contemporary bacterial pathogens from the United States and Europe, 2014. Antimicrob Agents Chemother. 2017;61(4):e02609–16.CrossRefPubMedPubMedCentralGoogle Scholar
  7. 7.
    McCurdy S, Lawrence L, Quintas M, et al. In vitro activity of delafloxacin and microbiological response against fluoroquinolone susceptible and non-susceptible S. aureus isolates from two phase 3 studies of acute bacterial skin and skin structure infections (ABSSSI). Antimicrob Agents Chemother. 2017. doi:10.1128/AAC.00772-17.PubMedGoogle Scholar
  8. 8.
    Remy JM, Marra A, Duffy E. Bactericidal activity of delafloxacin against recent isolates of Staphylococcus aureus [abstract no. SUNDAY-472]. In: ASM Microbe. 2016.Google Scholar
  9. 9.
    Lepak AJ, Andes DR. In vivo pharmacodynamic target assessment of delafloxacin against Staphylococcus aureus, Streptococcus pneumoniae, and Klebsiella pneumoniae in a murine lung infection model. Antimicrob Agents Chemother. 2016;60(8):4764–9.CrossRefPubMedPubMedCentralGoogle Scholar
  10. 10.
    Litwin JS, Benedict MS, Thorn MD, et al. A thorough QT study to evaluate the effects of therapeutic and supratherapeutic doses of delafloxacin on cardiac repolarization. Antimicrob Agents Chemother. 2015;59(6):3469–73.CrossRefPubMedPubMedCentralGoogle Scholar
  11. 11.
    Lawrence LE, Ferguson J, Paulson S. Assessment of phototoxicity potential of delafloxacin in healthy male and female subjects: a phase 1 study [abstract no. F-1198a]. In: ICAAC/ICC. 2015.Google Scholar
  12. 12.
    Hoover R, Hunt T, Benedict M, et al. Safety, tolerability, and pharmacokinetic properties of intravenous delafloxacin after single and multiple doses in healthy volunteers. Clin Ther. 2016;38(1):53–65.CrossRefPubMedGoogle Scholar
  13. 13.
    Hoover R, Hunt T, Benedict M, et al. Single and multiple ascending-dose studies of oral delafloxacin: effects of food, sex, and age. Clin Ther. 2016;38(1):39–52.CrossRefPubMedGoogle Scholar
  14. 14.
    Hoover R, Marbury TC, Preston RA, et al. Clinical pharmacology of delafloxacin in patients with hepatic impairment. J Clin Pharmacol. 2017;57(3):328–35.CrossRefPubMedGoogle Scholar
  15. 15.
    Paulson SK, Wood-Horrall RN, Hoover R, et al. The pharmacokinetics of the CYP3A substrate midazolam after steady-state dosing of delafloxacin. Clin Ther. 2017;39(6):1182–90.CrossRefPubMedGoogle Scholar
  16. 16.
    Cammarata S, Gardovskis J, Farley B, et al. Results of a global phase 3 study of delafloxacin (DLX) compared to vancomycin with aztreonam (VAN) in acute bacterial skin and skin structure infections (ABSSSI) [abstract no. 776 plus poster]. In: ICAAC/ICC. 2015.Google Scholar
  17. 17.
    O’Riordan W, Mc Manus A, Teras J, et al. A global phase 3 study of delafloxacin compared to vancomycin/aztreonam in patients with acute bacterial skin and skin structure infections [abstract no. 1347 plus poster]. In: IDWeek. 2016.Google Scholar
  18. 18.
    O’Riordan W, Mehra P, Manos P, et al. A randomized phase 2 study comparing two doses of delafloxacin with tigecycline in adults with complicated skin and skin-structure infections. Int J Infect Dis. 2015;30:67–73.CrossRefPubMedGoogle Scholar
  19. 19.
    Kingsley J, Mehra P, Lawrence LE, et al. A randomized, double-blind, Phase 2 study to evaluate subjective and objective outcomes in patients with acute bacterial skin and skin structure infections treated with delafloxacin, linezolid or vancomycin. J Antimicrob Chemother. 2016;71(3):821–9.CrossRefPubMedGoogle Scholar

Copyright information

© Springer International Publishing AG 2017

Authors and Affiliations

  1. 1.SpringerAucklandNew Zealand

Personalised recommendations