Wednesday, July 29, 2009 9:01:03 AM
The primary efficacy endpoint is the proportion of patients whose serum urate level is less than 6.0 mg/dL following four weeks of treatment. This study will be conducted at multiple sites in Europe and North America, with initial results expected by the end of 2009. The remaining studies in the planned Phase 2 program, including a Phase 2 study evaluating RDEA594 as an add-on to allopurinol in patients not responding adequately to allopurinol alone, a drug-drug interaction study with febuxostat (marketed as Uloric by Takeda Pharma and Adenuric by Ipsen), and a study in patients with renal impairment, are expected to begin shortly.
http://seekingalpha.com/article/150218-fda-calendar-updates-staar-surgical-spectrum-pharma-allergan-incyte-ardea?source=yahoo
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