A new treatment for adults with acute bacterial skin and skin-structure infections has been granted approval by the US Food and Drug Administration (FDA). Baxdela (delafloxacin) is available as an intravenous formulation and in oral form and was developed by Melinta Therapeutics. It is a fluoroquinolone that has proved effective against a number of infections, including methicillin-resistant Staphylococcus aureus (MRSA). Other drugs used to treat patients with acute bacterial skin infections include Vancomycin and Teflaro (ceftaroline).
Baxdela (delafloxacin) received a priority review by the regulatory body because of its status as a qualified infectious disease product (QDIP). Under the Generating Antibiotic Incentives Now (GAIN) Act, QDIPs can be fast tracked or receive a priority review from the FDA. The drug was determined as safe and effective based on two randomized clinical trials. These compared the new product with an intravenous combination of vancomycin and aztreonam. In both studies, delafloxacin was shown to be just as effective in shrinking skin lesions by at least 20% in two to three days.
What is Baxdela?
- Baxdela is an anionic fluoroquinolone antibiotic, which is used to treat one out of three hospital-treated infections. It is available in tablet and intravenous form.
Who can use Baxdela (delafloxacin)?
- Adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible bacteria.
- It should only be used to treat infections proven or strongly suspected to have been caused by bacteria. Clinicians have been advised to only prescribe Baxdela in these instances in order to reduce the development of drug-resistant bacteria.
Who shouldn't use Baxdela?
- Patients with known hypersensitivity to Baxdela or other fluoroquinolones.
- This can result in serious adverse reactions, including: tendinitis and tendon rupture, peripheral neuropathy, and central nervous system effects.
- Patients with a history of myasthenia gravis.
- Patients taking antacids containing aluminum or magnesium, with sucralfate, with metal cations such as iron, or with multivitamins containing iron or zinc, or with formulations containing divalent and trivalent cations such as didanosine buffered tablets for oral suspension or the pediatric powder for oral solution.
- Oral administration of Baxdela with the above may result in interference with the absorption of the medication.
- Patients under 18 years of age.
- Use should be discontinued if patients experience any adverse reactions.
Common adverse reactions:
- The most common adverse reactions to the drug, with an incidence of under 2 percent, are: nausea, diarrhea, headache, transaminase elevations, and vomiting.
For more information on Baxdela (delafloxacin), visit: http://www.baxdela.com/docs/baxdela-patient-medication-guide.pdf
