Baxdela (delafloxacin): United States

  PRODUCT/INDICATION PRE CLINICAL PHASE 1 PHASE 2 PHASE 3 NDA Submitted FDA Approved
Serious Skin Infections (ABSSSI)
IV-ORAL FORMULATIONS (QIDP)
IV (QIDP)
Oral (QIDP)
Serious Community-Acquired Bacterial Pneumonia (CABP)
IV-ORAL (QIDP)
(QIDP)
Complicated Urinary Tract Infections (cUTI)
IV-ORAL
(QIDP ELIGIBLE)
PRODUCT/INDICATION DELIVERY/PHASE
Baxdela™ (delafloxacin)
Serious Skin Infections (ABSSSI)
IV-ORAL FORMULATIONS (QIDP)
IV (QIDP) / FDA Approved
Oral (QIDP) / FDA Approved
Serious Community-Acquired Bacterial Pneumonia (CABP)
IV-ORAL (QIDP)
(QIDP) / Phase 3
Complicated Urinary Tract Infections (cUTI)
IV-ORAL
(QIDP ELIGIBLE) / Phase 1
  • ABSSSI: Acute bacterial skin and skin structure infections || CABP: Community-acquired bacterial pneumonia
    cUTI: Complicated urinary tract infections || QIDP: Qualified Infectious Disease Product

BAXDELA™ (delafloxacin) is FDA approved in the US for the treatment of serious skin infections known as acute bacterial skin and skin structure infections (ABSSSI). For more information about Baxdela for treatment of ABSSSI, please visit www.Baxdela.com.

Baxdela is an anionic fluoroquinolone antibiotic, a class currently used in one out of three hospital-treated infections. Baxdela has demonstrated in-vitro and clinical activity against Gram-positive and Gram-negative pathogens, including activity against MRSA (methicillin-resistant Staphylococcus aureus), a major cause of hospital-treated skin infections. Baxdela provides for convenient administration with both intravenous and oral forms.

Baxdela is indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following:

  • Gram-positive organisms. Staphylococcus aureus (including methicillin-resistant [MRSA] and methicillin-susceptible [MSSA] isolates), Staphylococcus haemolyticus, Staphylococcus lugdunensis, Streptococcus agalactiae, Streptococcus anginosus Group (including Streptococcus anginosus, Streptococcus intermedius, and Streptococcus constellatus), Streptococcus pyogenes, and Enterococcus faecalis;
  • Gram-negative organisms. Escherichia coli, Enterobacter cloacae, Klebsiella pneumoniae, and Pseudomonas aeruginosa.

WARNINGS AND PRECAUTIONS: Tendinitis and Tendon Rupture, Peripheral Neuropathy, Central Nervous System Effects, Exacerbation of Myasthenia Gravis, Hypersensitivity Reactions, and Clostridium difficile-Associated Diarrhea, and Development of Drug-Resistant Bacteria.

CONTRAINDICATIONS: Baxdela is contraindicated in patients with known hypersensitivity to delafloxacin or any of the fluoroquinolone class of antibacterial drugs, or any of the components of Baxdela.

ADVERSE REACTIONS: Most common adverse reactions (incidence ≥ 2%) are nausea, diarrhea, headache, transaminase elevations and vomiting.

Development Status for New Indications

Melinta is conducting a Phase 3 clinical program in serious community-acquired bacterial pneumonia (CABP) and may develop additional indications such as complicated urinary tract infections (cUTI). Quinolones are considered a standard of care in the treatment of CABP and cUTI. Baxdela is not currently FDA approved for the treatment of CABP or cUTI.

Melinta has received Qualified Infectious Disease Product (QIDP) designation from the U.S. FDA for the ABSSSI and CABP indications, which provides Baxdela with priority review and extends its market exclusivity period by an additional 5 years beyond the 5 years provided by Hatch-Waxman legislation.

Melinta has partnerships in place for delafloxacin outside the US. For more information on those partners, please visit our Partnering page.