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"...
You may also be interested in...
Aquavan NDA Delayed While Guilford Adjusts Dosing In Phase III Study
Guilford's suspension of Aquavan Phase III trial enrollment to recalculate dosing levels will delay an NDA filing until the second half of 2006, the firm says
Simplified Clinical Trial Transparency Rules To Go Live In The EU In June
A new version of the EU Clinical Trials Information System’s public portal will integrate the functionalities of the streamlined transparency rules.
Top-Selling Drugs 2023: Pharma’s $60bn COVID-19 Cliff
Pfizer/BioNTech’s COVID-19 vaccine Comirnaty toppled after recording the highest ever annual sales for a pharmaceutical in 2022, while Novo Nordisk’s Ozempic climbed rapidly. But Merck & Co’s immuno-oncology blockbuster Keytruda was secure in the number one spot in 2023 as COVID-19 receded.