Melinta Therapeutics, Inc. , a commercial-stage company developing and commercializing novel antibiotics to treat serious bacterial infections, today announced the U.S. launch of intravenous and oral formulations of Baxdela™ (delafloxacin) for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible bacteria. With Baxdela, 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.
“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. “I would especially like to thank the doctors and patients around the world that participated in our Baxdela clinical trial program, as well as the Melinta team that has worked tirelessly over many years to bring Baxdela to the market. It is because of their dedication that we are able to offer patients and healthcare providers this new treatment option.”
LISTEN: Antibiotics: Skin infections and the FDA approval of Baxdela
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.
“We believe that Baxdela will be an important treatment option for providers treating serious skin infections in both the hospital and community settings,” commented Mike McGuire, Melinta’s senior vice president, Commercial. “These patients often present treatment challenges owing to their underlying medical conditions (e.g., comorbidities such as obesity and diabetes), which can make optimal antibiotic selection difficult. The launch has the support of an experienced sales team and is further enhanced by the availability of three antimicrobial susceptibility tests that offer providers a full set of clinical tools to determine how to treat patients appropriately.”