Drug Information for MOXATAG™ (amoxicillin extended-release) Tablets (MiddleBrook Pharmaceuticals, Inc.): CLINICAL STUDIES

  • In a randomized, parallel-group, multi-center, double-blind, double-dummy study in adults and pediatrics (age≥ 12 years) with tonsillitis and/or pharyngitis secondary to S. pyogenes, MOXATAG 775 mg QD for 10 days was non-inferior to penicillin VK 250 mg QID for 10 days.

    Using strict evaluability and microbiologic response criteria 4-8 days post-therapy, the following bacteriological eradication rates and statistical outcomes in the per-protocol (PPb) and modified intent-to-treat (mITT) populations were obtained (Table 4). The mITT population included all randomized patients with a positive throat culture for S. pyogenes at baseline. The PPb population included mITT patients who had post-therapy cultures, were compliant with treatment, and didn't have major protocol violations.

    Table 4. Bacteriological Eradication Rates in Patients with Tonsillitis and/or Pharyngitis
    StudyPopulationMOXATAGPenicillin VKRate Difference95% CI (%)
    PPb198/233(85.0%)191/229(83.4%)1.6 (-5.1, 8.2)
    mITT204/256(79.7%)206/264(78.0%)1.7 (-5.4, 8.7)
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