Guilford restarts Aquavan clinical program
This article was originally published in Pharmaceutical Approvals Monthly
Revised clinical development strategy for Guilford's Phase III Aquavan (propofol prodrug) procedural sedative agreed to by FDA will include two pivotal trials - one in colonoscopy and the other in minor surgical procedures, the firm says. A prerequisite dose-ranging study in colonoscopy is planned. Guilford suspended Phase III trial enrollment in April after an interim analysis indicated that doses to date have been too high, pushing back NDA filing plans to the second-half of 2006 (1Pharmaceutical Approvals Monthly April 2005, p. 13). Under the revised strategy, Guilford will "immediately" re-initiate previously planned studies for ICU sedation and potential drug interactions, the firm says...
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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
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