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Additional Relevant Details The global pivotal Phase 3 registration study, known as OASIS (Omadacycline in Acute Skin and Skin Structure Infections Study), evaluated the efficacy and safety of an IV to oral once-daily omadacycline against twice daily linezolid over a 7 to 14-day course of therapy in 645 treated patients. The primary efficacy endpoint for the FDA is Early Clinical Response (ECR) at 48 to 72 hours after the first dose of study drug in the modified Intent to Treat (mITT) population (patients without a potentially causative monomicrobial gram-negative infection). In the mITT analysis population, omadacycline achieved the primary efficacy endpoint of statistical non-inferiority (10% margin) compared to linezolid. The ECR for the omadacycline and linezolid treatment arms was 84.8% compared to 85.5%, respectively.

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Clinical Data The co-primary efficacy endpoints for the EMA are the investigators assessment of clinical response at the post treatment evaluation (PTE) in the mITT and the clinically evaluable (CE) populations. In both populations at PTE, omadacycline achieved the primary efficacy endpoint of statistical non-inferiority (10% margin) compared to linezolid. In the mITT population at PTE, clinical success rates for the omadacycline and linezolid treatment arms were 86.1% and 83.6%, respectively. In the CE population at PTE, clinical success rates for the omadacycline and linezolid treatment arms were 96.3% and 93.5%, respectively. Omadacycline demonstrated comparable clinical success rates to linezolid caused by the most common ABSSSI pathogens, including methicillin-resistant Staphylococcus aureus (MRSA).Omadacycline was generally safe and well tolerated. Among treatment-emergent adverse events (TEAEs), gastrointestinal events were most common in both treatment groups (18.0% for omadacycline and 15.8% for linezolid): the most common individual TEAEs (≥ 3% in either group) included nausea (12.4% vs. 9.9%), vomiting (5.3% vs. 5.0%), and diarrhea (2.2% vs. 3.1%) for omadacycline and linezolid, respectively. Discontinuation for gastrointestinal TEAEs was uncommon, occurring in only one omadacycline patient (vomiting) and one linezolid patient (nausea and constipation). Infusion site reactions associated with IV study drug therapy occurred in 9.6% of omadacycline patients and 8.4% of linezolid patients none of which led to study drug discontinuation. Of these events phlebitis was only 2.5% in both treatment arms. Serious TEAEs occurred in 3.4% of omadacycline patients and 2.5% of linezolid patients, none of which were considered related to study drug. Two deaths occurred during the study, both in the linezolid group (cardiac arrest and cardiac failure).

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