Baxdela (delafloxacin) - 2 indications

Scroll down for information on each indication:

• Acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible bacteria; approved 06/01/2017
• Community-Acquired Bacterial Pneumonia; approved 10/01/2019

General Information

Baxdela (delafloxacin) is a fluoroquinolone antibacterial.

Baxdela is specifically indicated for the following indications:

• Adults with acute bacterial skin and skin structure infections (ABSSSI) caused by the following susceptible microorganisms: 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.
• Adults with community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms: Streptococcus pneumoniae, Staphylococcus aureus (methicillinsusceptible [MSSA] isolates only), Klebsiella pneumoniae, Escherichia coli, Pseudomonas aeruginosa, Haemophilus influenzae, Haemophilus parainfluenzae, Chlamydia pneumoniae, Legionella pneumophila, and Mycoplasma pneumoniae.

Baxdela is supplied as a tablet for oral administration or a solution for intravenous injection. The recommended doses are as follows:

Baxdela tablets: Administer tablets at least 2 hours before or 6 hours after antacids containing magnesium, or aluminum, with sucralfate, with metal cations such as iron, or with multivitamin preparations containing zinc or iron, or with didanosine buffered tablets for oral suspension or the pediatric powder for oral solution. Baxdela tablets can be taken with or without food. If patients miss a dose, they should take it as soon as possible anytime up to 8 hours prior to their next scheduled dose. If less than 8 hours remain before the next dose, wait until their next scheduled dose.

Baxdela for Injection: Do NOT administer Baxdela for Injection with any solution containing multivalent cations, e.g., calcium and magnesium, through the same intravenous line. Do NOT co-infuse Baxdela for Injection with other medications.

Patients should receive 300 mg of Baxdela for Injection every 12 hours over 60 minutes by intravenous infusion, OR 300 mg of Baxdela for Injection every 12 hours over 60 minutes by intravenous infusion, then switch to a 450 mg Baxdela tablet orally every 12 hours at the discretion of the physician OR 450 mg Baxdela tablet orally every 12 hours.

Mechanism of Action

Baxdela (delafloxacin) is a fluoroquinolone antibacterial. The antibacterial activity of delafloxacin is due to the inhibition of both bacterial topoisomerase IV and DNA gyrase (topoisomerase II) enzymes which are required for bacterial DNA replication, transcription, repair, and recombination. Delafloxacin exhibits a concentration-dependent bactericidal activity against gram-positive and gram-negative bacteria in vitro.

Side Effects

Adverse effects associated with the use of Baxdela may include, but are not limited to, the following:

• nausea
• diarrhea
• headache
• transaminase elevations
• vomiting

The Baxdela drug label comes with the following Black Box Warning: Fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together, including: Tendinitis and tendon rupture, Peripheral neuropathy, Central nervous system effects. Discontinue Baxdela immediately and avoid the use of fluoroquinolones, including Baxdela, in patients who experience any of these serious adverse reactions. Fluoroquinolones may exacerbate muscle weakness in patients with myasthenia gravis. Avoid Baxdela in patients with known history of myasthenia gravis.

Indication 1 - Acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible bacteria

approved 06/01/2017

Clinical Trial Results

The FDA approval of Baxdela for ABSSSI was based on two phase III trials. A total of 1,510 adults with ABSSSI were randomized in two multicenter, multinational, double-blind, double-dummy, non-inferiority trials. Trial 1 compared Baxdela 300 mg via intravenous infusion every 12 hours to comparator. In Trial 2, patients received Baxdela 300 mg via intravenous infusion every 12 hours for 6 doses then made a mandatory switch to oral Baxdela 450 mg every 12 hours. In both studies, the comparator was the intravenous combination of vancomycin 15 mg/kg actual body weight and aztreonam. Both IV and oral Baxdela monotherapy was statistically non-inferior to the combination of vancomycin plus aztreonam at the FDA primary endpoint of early clinical response at 48-72 hours.

Indication 2 - Community-Acquired Bacterial Pneumonia

approved 10/01/2019

Clinical Trial Results

The FDA approval of Baxdela for the treatment of CABP was based on positive results from a Phase III, randomized, double-blind, study that compared the efficacy and safety of Baxdela to moxifloxacin. The study results demonstrated that Baxdela met all key primary and secondary endpoints in the trial.  In the intent-to-treat population (ITT), IV-to-oral Baxdela met the FDA primary endpoint of statistical non-inferiority for the Early Clinical Response at 96 hours (± 24 hours) after initiation of therapy (88.9% ECR in BAXDELA patients) compared to IV/oral moxifloxacin (89.0%). Baxdela also met the FDA secondary endpoint of statistical non-inferiority (90.5%) compared to moxifloxacin (89.7%) based on the investigator’s assessment of Success at the Test of Cure visit (5-10 days after last dose) in the ITT population. Data further showed that IV/oral Baxdela successfully eradicated key respiratory pathogens at rates comparable to moxifloxacin.