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Guilford Aquavan enters Phase III

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Guilford initiates a Phase III study of its propofol prodrug Aquavan for sedation of patients undergoing colonoscopy, the firm announces Sept. 20. The 267-patient, open-label, evaluator-blinded study is the first of several in the Aquavan Phase III program. Guilford plans to seek approval for "procedural sedation for brief diagnostic and therapeutic procedures such as colonoscopy, bronchoscopy, interventional cardiology and minor surgical procedures." Aquavan's water solubility could yield advantages over propofol, which is formulated in an oil or lipid-based emulsion, Guilford claims. Advantages "may include potentially fewer side effects, such as cardiovascular side effects, elevated blood lipid levels (hyperlipidemia), increased ease of use, improved stability, reduced risk of bacterial contamination and pain upon injection"...

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