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Arpida's Antibiotic Shows Positive Results in Drug Interaction Trial

Posted on: Thursday, 22 November 2007, 15:00 CST

Arpida has reported positive results of a Phase I trial investigating the possible interaction between its investigational antibiotic intravenous iclaprim and warfarin.

The drug-drug interaction study comprised 24 healthy volunteers and was performed in Germany. Administration of intravenous iclaprim at the supra-therapeutic dose was assessed to be safe for clinical applications. It had no significant effect on the pharmakonetics and pharmacodynamics of warfarin.

Moreover, the trial results confirm the good safety and tolerability profile of iclaprim. Dosing of warfarin with and without pre- and co-administration of iclaprim (1.6mg/kg infused over 60 minutes) was investigated.

Warfarin is widely used for the prophylaxis of thrombosis and embolism and its dosing needs to be well-controlled. Intravenous iclaprim is a potent, pathogen-focused, late-stage antibiotic that targets severe infections requiring hospital treatment, including those caused by methicillin-resistant Staphylococcus aureus.

Paul Hadvary, head of development of Arpida, said: "These Phase I data add substantial weight to the new drug application package that we intend to file shortly with the FDA for intravenous iclaprim in its first indication, complicated skin and skins structure infections."

Source: Datamonitor

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