Cardiome Oxyprim Phase IV Trial Design Will Be Part Of Chronic Gout Trial Design Cmte. Meeting
This article was originally published in The Pink Sheet Daily
Executive Summary
The Phase IV proposal will act as a case study for FDA's Arthritis Advisory Committee's discussion June 2. The study will fulfill accelerated approval requirements for oxypurinol, which has a June 23 user fee date. The committee will also look at acute gout; Merck's Arcoxia will be discussed.