Fusidic Acid

  PRODUCT/INDICATION PRE CLINICAL PHASE 1 PHASE 2 PHASE 3 NDA Submitted FDA Approved
Skin infections (ABSSSI)
Oral (QIDP)
Chronic bone and joint infections
Oral
PRODUCT/INDICATION DELIVERY/PHASE
Taksta (fusidic acid)
Skin infections (ABSSSI)
Oral (QIDP) / Phase 3
Chronic bone and joint infections
Oral / Phase 2

Fusidic acid an antibiotic with a long history of safety and efficacy outside the U.S and is orally active against gram-positive bacteria, including MRSA. Fusidic acid successfully completed a Phase 3 clinical study in ABSSSI patients and results were announced in the first quarter of 2017. Based on discussions with the FDA, a second Phase 3 study with a similar design to the first Phase 3 study could support potential approval of fusidic acid in patients with ABSSSI in the U.S.

Melinta plans to explore the potential use of fusidic acid for the long-term treatment of BJI, including prosthetic joint infections caused by staphylococci, including Staphylococcus aureus and MRSA. There are limited oral antibiotic treatment options that are suitable for chronic therapy. Melinta has completed enrollment in a 30 patient exploratory, open-label study to assess the safety of long term therapy and clinical success six months after the start of treatment.