Savient Completes Phase III Studies for Treatment-Failure Gout
Posted on: Thursday, 18 October 2007, 15:00 CDT
Savient Pharmaceuticals has completed the in-life portion of its two Phase III clinical trials for Puricase in patients with treatment-failure gout, an orphan indication.
The two Phase III pivotal trials assessed the safety and efficacy of a six-month course of Puricase therapy in patients with treatment-failure gout, under the auspices of a special protocol assessment from the FDA.
The studies consisted of two replicate protocols; each a randomized, double-blinded, placebo controlled study of six months duration in which Puricase or placebo was administered by a two-hour intravenous infusion. Approximately 110 patients were randomized into each study and a total of 212 patients received at least one dose of study medication (Puricase or placebo).
Each study had three arms: placebo, Puricase 8mg administered every two weeks, or Puricase 8mg administered every four weeks. In order to maintain blind to the treatment assignment, all patients received an intravenous infusion every two weeks.
Puricase is a pegylated recombinant mammalian urate oxidase that is being developed to control hyperuricemia and its clinical consequences in patients for whom conventional therapy is contraindicated or has been ineffective.
Assigned by the USAN Council, Pegloticase now has become the official generic name for Puricase.
Source: Datamonitor
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