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Cempra's Pivotal Phase 3 SOLITAIRE-IV Study of IV to Oral Solithromycin Published in Clinical Infectious Diseases

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Additional Relevant Details As previously reported, the SOLITAIRE-IV study demonstrated that solithromycin was non-inferior to moxifloxacin, a potent respiratory fluoroquinolone, for treatment of CABP, meeting its primary endpoint that was aligned with FDA guidance.Cempra's other pivotal Phase 3 study with solithromycin, SOLITAIRE-ORAL, which evaluated the efficacy and safety of oral solithromycin versus oral moxifloxacin for the treatment of CABP, also met its primary non-inferiority endpoint and was published in Lancet Infectious Diseases in February 2016."The SOLITAIRE-IV study highlights the potential for physicians to transition CABP patients from IV to oral solithromycin, without needing to add or change drug classes. This type of approach could have significant clinical and public health benefits," said Thomas M. File, M.D., from Northeast Ohio Medical University and lead author of the study.
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Occurred on:
Aug 25, 2016
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Related Keywords Solitaire-iv, Solithromycin, Clinical Infectious Diseases