Melinta Therapeutics announced the availability of oral and intravenous (IV) forms of Baxdela (delafloxacin) for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible bacteria.
Baxdela, a fluoroquinolone antibiotic, was initially approved by the Food and Drug Administration (FDA) in June 2017.
It is intended to treat susceptible isolates of the following gram-positive and gram-negative organisms: Staphylococcus aureus (including methicillin-resistant [MRSA] and methicillin-susceptible [MSSA] isolates), Staphylococcus haemolyticus, Staphylococcus lugdunensis, Streptococcus agalactiae, Streptococcus anginosus group (including Streptococcus anginosus, Streptococcus intermedius, and Streptococcus constellatus), Streptococcus pyogenes, Enterococcus faecalis, Escherichia coli, Enterobacter cloacae, Klebsiella pneumoniae, and Pseudomonas aeruginosa.
Baxdela exerts antibacterial activity through inhibition of both bacterial topoisomerase IV and DNA gyrase (topoisomerase II) enzymes needed for bacterial DNA replication, transcription, repair, and recombination.
It exhibits concentration-dependent bactericidal activity against gram-positive and gram-negative bacteria in vitro. No dose adjustments are needed for body weight, hepatic impairment, or mild-to-moderate renal impairment.
Baxdela is available as 450 mg strength tablets in 20-count bottles and as 300 mg strength lyophilized powder in single-dose vials in 10-count cartons. The 450mg tablet is bioequivalent to, and interchangeable with, the 300mg IV dose.
Meltina Therapeutics launches antibiotic Baxdela™ (delafloxacin) in the United States [press release]. New Haven, CT; Globe Newswire; January, 29, 2018. Accessed February 5, 2018.
This article originally appeared on MPR