Melinta Therapeutics Submits Baxdela New Drug Application for Hospital-Treated Skin Infections
Melinta Therapeutics, a privately held company developing novel antibiotics to treat serious bacterial infections, announced today that it has submitted New Drug Applications (NDAs) to the U.S. Food and Drug Administration (FDA) for approval of IV and oral Baxdela™ (delafloxacin) for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI). Baxdela is an investigational anionic fluoroquinolone with a broad spectrum of antimicrobial activity, including activity against methicillin-resistant Staphylococcus aureus (MRSA). Melinta’s NDAs are based on the results of two Phase 3 studies (NCT01811732 and NCT01984684), in both of which Baxdela met the primary endpoint of non-inferiority to a combination regimen of vancomycin plus aztreonam in reducing lesion size at the primary infection site at 48-to-72 hours. In addition, Baxdela met the primary endpoint, the investigator assessment of clinical cure, for the European Medicines Agency (EMA) in both studies. Baxdela was shown to be well tolerated among Phase 3 study participants, with less than 1% of patients discontinuing for treatment-related adverse events.