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FDA approves Baxdela for treatment of ABSSSIs
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The FDA recently approved an IV and oral formulation of Baxdela, an anionic fluoroquinolone, for the treatment of acute bacterial skin and skin structure infections, or ABSSSIs, including MRSA.
The approval of both formulations is supported by data from two phase 3 trials that showed Baxdela (delafloxacin, Melinta Therapeutics) had similar safety and efficacy profiles against ABSSSIs compared with a combination regimen of vancomycin and aztreonam, according to a press release from the manufacturer.
Eugene Sun, MD, CEO of Melinta, told Infectious Disease News that the approval provides clinicians with another weapon against serious skin infections, which affect an estimated 3 million people in the United States each year.
“There is an advantage to being able to accomplish the same thing with one drug vs. two drugs. You are better off from the side effect standpoint,” he said. “The fact that there is an IV and oral formulation is clinically important because it provides an option for patients who begin to feel better to be discharged from the hospital on the same drug or potentially even avoid hospitalization with primary use of the oral formulation.”
Delafloxacin has a wide spectrum of activity against MRSA and other important pathogens, including Staphylococcus aureus and invasive group A Streptococcus, according to David C. Hooper, MD, professor of medicine at Harvard Medical School and chief of the Infection Control Unit and associate chief of the Division of Infectious Diseases at Massachusetts General Hospital.
“It also has gram-negative activity, which can be important in some skin infections, but clearly S. aureus and group A Streptococcus are the dominant pathogens,” Hooper told Infectious Disease News. “The oral availability is useful because there are relatively few oral agents that can be used to treat MRSA infections, in particular.”
Sun anticipates that delafloxacin will be available on the market sometime this fall.
“We are very cognizant of the ecology of correct antibiotic use and we intend to be very adherent to the principles of stewardship,” Sun said. “Baxdela is a very powerful antibiotic, and it is most appropriate for patients with serious infections. However, resistance is an inevitable fact of life, and we think that by using it in a circumspect way, we can keep it at bay as long as possible.”– by Stephanie Viguers
Disclosures: Hooper reports serving on the delafloxacin advisory board for Melinta. Sun is CEO of Melinta.