NEW HAVEN: Melinta Therapeutics, Inc. [NASDAQ:MLNT], is launching intravenous and oral formulations of Baxdela™ [delafloxacin] for the treatment of adult patients with acute bacterial skin and skin structure infections [ABSSSI] in the US.
Melinta has previously announced partnership agreements to launch Baxdela in numerous countries across the world, the FDA approved Baxdela in June 2017.
According to the company “no dosage adjustments are required due to weight, hepatic impairment or mild-moderate renal impairment, there are no food effects, and there is minimal potential for drug interactions,” with the drug.
“Today’s launch of Baxdela is a significant milestone for Melinta – one that comes on the heels of a very successful year, cementing our leadership position in the antibiotics space,” stated Dan Wechsler, president & chief executive officer of Melinta.
The company says that approximately 14 million patients are treated for serious skin infections each year, either in the hospital or community settings, and these are often caused by MRSA.
“Baxdela’s performance in clinical trials of skin infections demonstrated a good clinical efficacy profile and was well-tolerated,” said James A. McKinnell, MD, assistant professor of medicine, David Geffen School of Medicine, University of California, Los Angeles. “Microbiologic activity and clinical effectiveness against MRSA make Baxdela a novel fluoroquinolone with potential for treating certain skin infections.”