Omadacycline in Skin Infections and Pneumonia: A Review of the Evidence.

Given the growing prevalence of antibiotic resistance globally, there is an urgent need for new therapy options that are effective and well tolerated for treatment of common infections such as bacterial skin infections and pneumonia. Here, we summarize the findings of 3 phase 3 clinical trials of omadacycline, a novel tetracycline-derived aminomethylcycline, in patients with acute bacterial skin and skin structure infections (ABSSSI; OASIS-1 [NCT02378480] and OASIS-2 [NCT02877927]) or community-acquired bacterial pneumonia (CABP; OPTIC [NCT02531438]). The primary endpoint in all studies was early clinical response (early response) at 2 to 3 days (skin studies) or 3 to 5 days (pneumonia study) after the first dose. Other endpoints included post-treatment evaluation (late response) and safety evaluations. Early and late responses were similar for omadacycline (85% to 88%) and linezolid (83% to 86%) in the skin infection studies. Similarly in the pneumonia study, early and late responses were similar for omadacycline and moxifloxacin: 81% and 88% vs 83% and 85%, respectively. No differences were observed in subgroup analyses, and high rates of clinical response were seen for all treatments against common pathogens. The most frequent adverse event reported was nausea, which was mostly associated with the loading dose in the oral-only regimen in OASIS-2. Overall, omadacycline was well tolerated and showed high rates of clinical response in patients with skin infections and pneumonia, including in those with comorbidities.