Home » Drug Information » FDA Approved Drugs » 2009
Medical Areas: Dermatology | Immunology | Family Medicine | Infections and Infectious Diseases
View By:YearCompanyConditionsTherapeutic AreasDrug Names
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved September 2009
Treatment Area: complicated skin and skin structure infections
Vibativ (telavancin) is a bactericidal, once-daily, injectable lipoglycopeptide antibiotic with a dual mechanism of action whereby Vibativ both inhibits bacterial cell wall synthesis and disrupts bacterial cell membrane function.
Vibativ is specifically indicated for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus), or Enterococcus faecalis (vancomycin-susceptible isolates only).
Vibativ is supplied as a powder for reconstitution onto a solution designed for intravenous administration. The recommended initial dose is 10 mg/kg administered over a 60-minute period in patients >18 years of age by intravenous infusion once every 24 hours for 7 to 14 days.
The FDA approval of Vibativ was based on two identical randomized, multinational, multicenter, double-blinded trials (Trial 1 and Trial 2) comparing Vibativ (10 mg/kg IV every 24 hours) with vancomycin (1 g 590 IV every 12 hours) for 7 to 14 days. The trials enrolled 1,794 adult subjects with cSSSI with suspected or confirmed MRSA as the primary cause of infection. Of the 1,794 enrolled subjects, 1,410 (78.6%) were clinically evaluable. The primary endpoint was non-inferiority in terms of the clinical cure rate at the follow-up test-of-cure visit. Results are from the clinically evaluable population: Trial One Vibativ: 84.3% and Vancomycin: 82.8%. Trial Two Vibativ: 83.9% and Vancomycin: 87.7%.
Ongoing Study Commitments
- Theravance has agreed to conduct a pregnancy registry to evaluate the safety of this product in pregnant women and their offspring. They will be required to evaluate the safety of Vibativ (telavancin) use during pregnancy by developing and maintaining a prospective, observational pregnancy exposure registry study conducted in the United States. The study should compare pregnancy and fetal/infant outcomes of women exposed to VIBATIV (telavancin) during pregnancy to an unexposed control population. The registry should identify and record major congenital anomalies, minor anomalies that occur in groups of three or more, spontaneous abortions, stillbirths, elective terminations, functional deficits in the child, and any serious pregnancy outcomes. Infants should be assessed through at least the first year of life. For more information.
Final protocol Submission: by 8/2009 (completed)
Interim Report: by 9/2010, then annually
Study completion date: by 6/2019
Final Report Submission: by 12/2019
- Theravance has agreed to conduct a prospective study over a five-year period after introduction of Vibativ (telavancin) to the market to determine if decreased susceptibility to VIBATIV (telavancin) is occurring in the target population of bacteria that are in the approved Vibativ (telavancin) package insert. Provide a detailed study protocol describing the study to the Agency for review and comment before commencing the study.
Final protocol Submission: by 1/2010
Interim Report Submission: by 3/2011, then annually
Study Completion Date: by 12/2014
Final Report Submission: by 5/2015
Adverse events associated with the use of Vibativ may include, but are not limited to, the following:
- taste disturbance
- foamy urine
Mechanism of Action
Vibativ is a semisynthetic, lipoglycopeptide antibiotic. It inhibits bacterial cell wall synthesis by interfering with the polymerization and cross-linking of peptidoglycan. Telavancin binds to the bacterial membrane and disrupts membrane barrier function.
Wilson SE, O'Riordan W, Hopkins A, Friedland HD, Barriere SL, Kitt MM; ATLAS Investigators Telavancin versus vancomycin for the treatment of complicated skin and skin-structure infections associated with surgical procedures. American Journal of Surgery 2009 Jun;197(6):791-6
Stryjewski ME, Graham DR, Wilson SE, O'Riordan W, Young D, Lentnek A, Ross DP, Fowler VG, Hopkins A, Friedland HD, Barriere SL, Kitt MM, Corey GR; Assessment of Telavancin in Complicated Skin and Skin-Structure Infections Study Telavancin versus vancomycin for the treatment of complicated skin and skin-structure infections caused by gram-positive organisms. Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America 2008 Jun 1;46(11):1683-93
Leonard SN, Rybak MJ Telavancin: an antimicrobial with a multifunctional mechanism of action for the treatment of serious gram-positive infections. Pharmacotherapy 2008 Apr;28(4):458-68
Stryjewski ME, Chu VH, O'Riordan WD, Warren BL, Dunbar LM, Young DM, Vallée M, Fowler VG Jr, Morganroth J, Barriere SL, Kitt MM, Corey GR; FAST 2 Investigator Group Telavancin versus standard therapy for treatment of complicated skin and skin structure infections caused by gram-positive bacteria: FAST 2 study. Antimicrobial Agents and Chemotherapy 2006 Mar;50(3):862-7
Stryjewski ME, O'Riordan WD, Lau WK, Pien FD, Dunbar LM, Vallee M, Fowler VG Jr, Chu VH, Spencer E, Barriere SL, Kitt MM, Cabell CH, Corey GR; FAST Investigator Group Telavancin versus standard therapy for treatment of complicated skin and soft-tissue infections due to gram-positive bacteria. Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America 2005 Jun 1;40(11):1601-7
For additional information regarding Vibativ or complicated skin and skin structure infections due to gram positive bacteria, please visit the Vibativ web page.