Delafloxacin: First Global Approval
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.
- 1.Melinta Therapeutics. BAXDELA (delafloxacin): US Prescribing Information. 2017. http://www.baxdelarx.com/docs/baxdela-prescribing-information.pdf. Accessed 14 Jul 2017.
- 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.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.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.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
- 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.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
- 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
- 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.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
- 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