Melinta Therapeutics files NDA at FDA for Baxdela (delafloxacin) to treat acute bacterial skin and skin structure infections (ABSSSI).

Ligand Pharmaceuticals Incorporated partner Melinta Therapeutics, a privately held company developing novel antibiotics to treat serious bacterial infections, announced that it has submitted New Drug Applications (NDAs) to the 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 III 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 III study participants, with less than 1% of patients discontinuing for treatment-related adverse events. With the submission, Ligand has earned a $1.5 million milestone payment.