24 October 2016 - Melinta Therapeutics announced today that it has submitted new drug applications to the U.S. FDA for approval of IV and oral Baxdela (delafloxacin) for the treatment of patients with an acute bacterial skin and/or skin structure infection. 

Baxdela is an investigational anionic fluoroquinolone with a broad spectrum of antimicrobial activity, including activity against methicillin-resistant Staphylococcus aureus (MRSA). Melinta’s applications 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 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.

Read Melinta Therapeutics press release