Delafloxacin Approved for Community-Acquired Bacterial Pneumonia

The FDA has approved the supplemental NDA for Baxdela for the treatment of community acquired bacterial pneumonia in adult patients.

The Food and Drug Administration has approved the supplemental New Drug Application (sNDA) for Baxdela (delafloxacin; Melinta Therapeutics) for the treatment of community acquired bacterial pneumonia (CABP) in adult patients.

The approval was based on results from the phase 3 DEFINE-CABP trial (N=860) that compared the efficacy and safety of Baxdela to moxifloxacin for the treatment of CABP. Patients were randomized to receive Baxdela 300mg intravenously (IV) every 12 hours (for ≥6 doses) or moxifloxacin 400mg IV every 24 hours (for ≥3 doses) with potential to switch to the oral formulation. The primary endpoint was early clinical response (ECR) defined as improvement in ≥2 of the following symptoms: chest pain, frequency or severity of cough, the amount and quality of productive sputum, and difficulty breathing, and no worsening in the other symptoms in the intent-to-treat population.

Results showed IV-to-oral Baxdela to be statistically non-inferior to IV-to-oral moxifloxacin for early clinical response at 96 hours (± 24 hours) after initiating therapy (88.9% vs 89.0% ECR, respectively). Additionally, Baxdela met the investigator’s assessment of success at the test of cure visit (secondary end point), defined as 5-10 days after the last dose, of statistical non-inferiority compared with moxifloxacin (90.5% vs 89.7%, respectively). Further analysis between both treatment arms also demonstrated similar rates of eradicated key respiratory pathogens. 

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The overall safety profile of Baxdela was comparable to moxifloxacin with the most common treatment-emergent adverse events being diarrhea and increased transaminase levels.

Baxdela, a fluoroquinolone antibiotic, is already indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of gram-positive and gram-negative organisms.

The product is available as 450mg strength tablets in 20-count bottles and as 300mg strength lyophilized powder in single-dose vials in 10-count cartons. The 450mg tablet is bioequivalent to, and interchangeable with, the 300mg IV dose.

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This article originally appeared on MPR