The FDA has approved delafloxacin (Baxdela, Melinta Therapeutics), a fluoroquinolone designed to treat adults with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible bacteria.
The Baxdela New Drug Application (NDA) approvals were supported by 2, phase 3 studies in patients with ABSSSI, demonstrating that 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, according to a statement from Melinta.1
Baxdela was well tolerated with a 0.9% discontinuation rate in the phase 3 studies due to adverse events. In addition, Baxdela has not shown any potential for QT prolongation or phototoxicity in definitive clinical studies. There have been no signals of adverse effects on liver function, kidney function, or glucose regulation in controlled clinical studies.
According to the statement from Melinta, the 450 mg tablet is bioequivalent (area under the curve) to, and interchangeable with the 300 mg IV dose, and can be dosed without regard to food.
“Antibiotic resistance is a growing concern, and physicians need more tools in the fight against this threat to modern medicine. Approval of new therapies like Baxdela, which is effective against methicillin-resistant Staphylococcus aureus (MRSA) and other serious pathogens, provides physicians another option in addressing the challenges of ABSSSI patients,” Dr. David Hooper, professor of medicine, Harvard University, and chief of Infection Control, associate chief, Division of Infectious Diseases, Massachusetts General Hospital said in the statement.
Melinta Therapeutics anounces US FDA Approval of Baxdela for acute bacterial skin and skin structure infections. NEW HAVEN, Conn. Melinta website. Accessed June 19, 2017.