Melinta Therapeutics announced that it has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for approval of intravenous (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). The 450mg tablet has demonstrated bioequivalent exposure (area under the curve [AUC]) to the 300mg IV dose.
The Baxdela NDAs are based on data from two Phase 3 studies (Study 302 and 303) where Baxdela met the primary endpoint of non-inferiority to vancomycin plus aztreonam in decreasing lesion size at the primary infection site at 48–72 hours. Baxdela also met the primary endpoint of investigator assessment of clinical cure for the European Medicines Agency in both studies.
The FDA has designated Baxdela as a Qualified Infectious Disease Product (QIDP). Baxdela is also being investigated in a clinical trial in patients with hospital-treated community-acquired bacterial pneumonia (CABP) and will be studied in a complicated urinary tract infections (cUTI) trial in the near future.
For more information visit Melinta.com.