IDWeek 2018 — Efficacy and safety data for newly FDA-approved omadacycline


  • Conference Reports
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Takeaway

  • Omadacycline’s in vivo efficacy is unaffected by tetracycline-resistance mechanisms of tetracycline-nonsusceptible pathogens from acute skin and skin structure infection (ABSSSI) and community-acquired bacterial pneumonia (CABP).
  • In addition to these efficacy results from the OPTIC and OASIS 1 and OASIS 2 trials, an integrated analysis of the OASIS trials focused on ABSSSI shows omadacycline effectiveness, safety, and tolerability.

Why this matters

  • The FDA approved omadacycline for CAPB and ABSSSI in early October.
  • The company said in a statement that omadacycline is the first and only once-daily intravenous and oral antibiotic approved for both conditions in almost 20 years.
  • The company expects it to be available in first quarter 2019.  

Key results

  • In the efficacy trials that involved molecularly characterized pathogens, 87.5% (14/16) of those treated with omadacycline in OPTIC and 100% (5/5) in the OASIS studies had clinical success.
  • The involved pathogen was Streptococcus pneumoniae.
  • Staphylococcus aureus and Escherichia coli were involved in indeterminate clinical response cases.
  • One Klebsiella pneumoniae case involved clinical failure.
  • In the integrated analysis, omadacycline performed similarly to comparator linezolid against S aureus (including methicillin-resistant S aureus), Streptococcus pyogenes, and Streptococcus anginosus.
  • Adverse event (AEs) rates were similar between the 2 (51% with omadacycline; 41% with linezolid).
  • Most frequent AEs related to treatment were nausea and vomiting.

Study design

  • The efficacy trial evaluated Gram-positive and Gram-negative isolates (24 and 17 samples, respectively): 26 from OPTIC, 10 from OASIS 1, and 5 from OASIS 2.
  • The integrated analysis involved data from OASIS 1 and OASIS 2 (oral only), with early clinical response compared between study drug and linezolid.
  • Funding: Paretek Pharmaceuticals.

Limitations

  • Small sample numbers for efficacy study.
  • Conference presentation; not peer-reviewed.