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KIMYRSA

oritavancin diphosphate

Peak

INTRAVENOUS · POWDER

12.1 Mechanism of Action Oritavancin is an antibacterial drug [see ] . 12.2 Pharmacodynamics The antimicrobial activity of oritavancin appears to correlate with the ratio of area under the concentration-time curve to minimal inhibitory concentration (AUC/MIC) based on animal models of infection. The AUC from time zero to 72 hours correlates with antimicrobial activity in both preclinical and clinical studies. Exposure-response analyses from both preclinical and clinical studies support the treatment of clinically relevant gram-positive microorganisms (e.g. S. aureus and S. pyogenes ) causative of ABSSSI with a single 1,200 mg dose of oritavancin. Cardiac Electrophysiology In a thorough QTc study of 135 healthy subjects at a dose 1.3 times the 1,200 mg recommended dose, oritavancin did not prolong the QTc interval to any clinically relevant extent. 12.3 Pharmacokinetics The mean (±SD) pharmacokinetic parameters of oritavancin products (KIMYRSA and oritavancin) in patients with ABSSSI are presented in Table 3. Table 3: Mean (±SD) Pharmacokinetic Parameters following a single 1,200 mg dose of KIMYRSA by intravenous infusion over 1 hour (N= 50) and Oritavancin by intravenous infusion over 3 hours (N=50) in Patients with ABSSSI Pharmacokinetic Parameter KIMYRSA (1 hour) Mean (± SD) Oritavancin (3 hour) Mean (± SD) C max , Maximum plasma concentration; AUC 0-72 , Area under the plasma concentration-time curve from time zero to 72 hours; SD, Standard deviation. C max (µg/mL) 148 (±43.0) 112 (±34.5) AUC 0-72 (h∙µg /mL) 1460 (±511) 1470 (±582) Oritavancin exhibits linear pharmacokinetics at a dose up to 1,200 mg. The mean, population-predicted oritavancin concentration-time profile displays a multi-exponential decline with a long terminal plasma half-life. Distribution Oritavancin is approximately 85% bound to human plasma proteins. Based on population pharmacokinetic (PK) analysis, the population mean total volume of distribution is estimated to be approximately 87.6 L, indicating that oritavancin is extensively distributed into the tissues. Exposures of oritavancin in skin blister fluid were approximately 20% of those in plasma (AUC 0-24 ) after single 800 mg dose in healthy subjects. Metabolism/Excretion Non-clinical studies, including in vitro human liver microsome studies, indicated that oritavancin is not metabolized. No mass balance study has been conducted in humans. In humans, oritavancin is slowly excreted unchanged in feces and urine, with less than 1% and 5% of the dose recovered in feces and urine, respectively, after 2 weeks of collection. Oritavancin has a terminal half-life of approximately 245 hours and a clearance of 0.445 L/h, based on population PK analyses. Specific Populations No dosage adjustments of KIMYRSA are required for patients with mild-to-moderate renal or mild-to-moderate hepatic impairment or other subpopulations, including age, gender, race, and weight. Renal Impairment The PK of oritavancin was examined in the Phase 3 AB

2021

$1M Part D

LOE: 2035

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