Baxdela Launched in US

Intravenous and oral formulations of delafloxacin (Baxdela) for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible bacteria were launched in the United States today, according to a press release from Melinta Therapeutics, Inc.

Melinta submitted their new drug application (NDA) for the drug back in 2016 and it was designated a Qualified Infectious Disease Product by the US Food and Drug Administration (FDA), making it a candidate for priority review. It was subsequently approved in June 2017.

In contrast to most FDA-approved fluoroquinolones, delafloxacin has an anionic character. This results in a 10-fold increase in delafloxacin accumulation in both bacteria and cells at acidic pH, which is believed to give the drug an advantage for the eradication of some bacteria in acidic environments.

Melinta reports that “The most common adverse reactions in patients treated with Baxdela were nausea (8%), diarrhea (8%), headache (3%), transaminase elevations (3%), and vomiting (2%).” Like all fluoroquinolones, delafloxacin has a Boxed Warning to alert health care professionals and patients that it can increase the risk of “disabling and potentially irreversible serious adverse reactions that have occurred together including tendinitis and tendon rupture, peripheral neuropathy, and central nervous system effects.” In addition, delafloxacin is contraindicated for patients with known hypersensitivity to fluoroquinolones.

As Contagion^® previously reported, “the only drug-drug interaction of note is the usual chelation agents, antacids and sulcralfate. There is no interaction with CYP450 isoforms or a range of hepatic and renal transporters with exception of P-gp and BCRP inhibitors, the relevance of this is unknown.”

Three antimicrobial susceptibility tests to guide appropriate use of the drug were approved in fall 2017. These were: Hardy Diagnostics’ Delafloxacin Antimicrobial Susceptibility Disk (HardyDisk), Liofilchem Delafloxacin MIC Test Strip (MTS), and Thermo Scientific Sensititre MIC System.

Baxdela is available in both tablet, 450 mg, and intravenous, 300 mg, formulations and it can be dosed for 5 to 14 days, twice daily. According to Melinta, “no dosage adjustments are required due to weight, hepatic impairment or mild-moderate renal impairment, there are no food effects, and there is minimal potential for drug interactions.”