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ORITAVANCIN

Semisynthetic glycopeptidic antibiotic

ANTI-INFETCTIVE

CURRENT DEVELOPMENT PHASE: ABSSSI

preclinicl
phase i
phase ii
phase iii
pre-registration
post-registration

Oritavancin is a semisynthetic glycopeptidic antibiotic, for intravenous administration, indicated for the treatment of acute Gram-positive skin and skin structure infections.

The structure of the molecule shows features responsible for the greatly enhanced antimicrobial potency of Oritavancin against Gram-positive organisms including Methicillin-Resistant Staphylococcus Aureus (MRSA) and those possessing both VanA- and VanB-mediated vancomycin-resistance.

Its pharmacokinetics profile allows the administration as single dose (1200 mg) by intravenous infusion over 3 hours, with the same benefits of vancomycin, a consolidated treatment for these infections which requires 2 infusions x day and can produce major adverse events.

To date, the EMA approved formulation consists of 3 vials to be used to reconstitute the medical solution for injection. Menarini is currently working on the development of a new Oritavancin dosage form consisting in 1 vial to favor the reconstitution of the medical solution in smaller volumes and to be administered in shorter times.

Clinical studies on pediatric populations are ongoing.

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