Fusidic acid (TAKSTATM, CEM-102) is an antibiotic with a long history of safety and efficacy outside the United States. Cempra has exclusive rights to the supply of the compound for the U.S. market. Fusidic acid is orally active against gram-positive bacteria, including all S. aureus strains such as HA-MRSA and CA-MRSA. A novel dosing regimen is in Phase II/III development for the treatment of acute bacterial skin and skin structure infections.
Profile of TAKSTA (CEM-102)
Skin and skin structure infections are most commonly caused by staphylococci and streptococci. Staphylococcus aureus strains resistant to currently available antibiotics are increasingly prevalent. It is estimated that between 60 and 80% of all skin S. aureus infections are MRSA. MRSA is no longer an infection that is only hospital-acquired; it is found frequently in the community as well. New oral antibiotics that can treat these infections and that are safe and convenient to use are needed.
CEM-102 has shown potent activity against a large number of S. aureus strains, including CA-MRSA, HA-MRSA and linezolid-resistant strains, isolated in the U.S over a 10 year period. Its broad S. aureus coverage makes it useful for a broad range of clinical applications. TAKSTA could be ideal for patients seen in emergency departments with severe skin and skin structure infections who are candidates for oral therapy. Hospital or long-term care patients who are IV intolerant, at high MRSA risk or require transition to oral therapy are also candidates for TAKSTA.
Cempra has developed a unique oral loading dose regimen to optimize key pathogen coverage and minimize drug resistance development. This regimen is incorporated in the upcoming Phase III trial that is designed to show non-inferiority to linezolid in patients with acute bacterial skin and skin structure infections.
Research on TAKSTA
CEM-102 (fusidic acid) in vitro activity and evaluation of molecular resistance mechanisms among European Gram-positive isolates, 2008-2009
M. Castanheira, D. Farrell, M. Janechek, R. Jones
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CEM-102 (Sodium Fusidate) Dosage Regimen Decision Support Using Population Pharmacokinetic (PPK) and Mechanism-Based Pharmacokinetic-Pharmacodynamic (PK-PD) Models
OO OKUSANYA, JB. BULITTA, A FORREST, BT TSUJI, SM BHAVNANI, J GORDON STILL, P FERNANDES, PG AMBROSE
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Contemporary Antimicrobial Activity of CEM-102 (Fusidic Acid [FA)]) Against Canadian Isolates of Staphylococci and Streptococci (2001-2006)
P. R. Rhomberg, L.N. Woosley, H.S. Sader, R. N. Jones
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Update on the Spectrum of CEM-102 (Fusidic Acid [FA)]) Against Contemporary Wildtype (WT) Bacterial Species Including Mutational Resistance (R) Analysis, and Synergy Testing
P. R. Rhomberg, R. E. Mendes, H. K. Becker, K. A. Fedler, H. S. Sader, R. N.
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Performance of CEM-102 (Fusidic Acid [FA)]) Susceptibility Testing Reagents; Broth Microdilution, Disk Diffusion and Etest Methods.
P. R. Rhomberg, L.N. Woosley, H.S. Sader, R. N. Jones
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Relevance of Protein Binding of CEM-102 (Fusidic acid) and its pH-dependent Effect on in vitro Activity
TP Degenhardt, PR Rhomberg, RN Jones, P Fernandes, D Johnson
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Contrasting Effect of Acidic pH on the Bactericidal Activities of CEM-102 (Fusidic Acid) vs. Linezolid and Clindamycin Towards Staphylococcus aureus
PM Tulkens, S Lemaire, F Van Bambeke
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Pharmacokinetics-Pharmacodynamics (PK-PD) of CEM-102 against Methicillin-Resistant Staphylococcus aureus (MRSA) using an In Vitro PD Model (IVPM) and Mechanism-Based (MB) Modeling
BT Tsuji, JB Bulitta, A Forrest, PA Kelchlin, T Brown, PN Holden, MP Pai, SM Bhavnani, P Fernandes, RN Jones, PG Ambrose
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Low CEM-102 (Fusidic Acid [FA]) Resistance (R) Rates and High Prevalence of Acquired (acq) Genes Among Staphylococcus spp. (SSP) from North America and Australia
M Castanheira, AA Watters, JM Bell, RN Jones, JD Turnidge
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Assessment of In Vivo Activity of CEM-102 (Fusidic Acid) in Murine Infection Models
T Murphy, S Little, R Wu, A Slee, P Fernandes
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Initial Quality Control (QC) Ranges for Fusidic Acid (FA) Using the CLSI Multi-Laboratory M23-A3 Study Design
RN Jones, JE Ross
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Population Pharmacokinetics (PPK) of CEM-102 in Healthy Subjects
JB Bulitta, OO Okusanya, A Forrest, SM Bhavnani, D Reynolds, MP Pai, JG Still, PB Fernandes, PG Ambrose
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Pharmacokinetics and Safety of Single, Multiple, and Loading Doses of CEM-102 in Healthy Subjects
JG Still, K Clark, TP Degenhardt, D Scott, P Fernandes, MJ Gutierrez
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From Mouse to Man: The Pharmacokinetics of CEM-102 (Fusidic acid)
TP Degenhardt, JG Still, K Clark, P Fernandes
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