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Home » SAVIENT COMPLETES PATIENT DOSING IN PHASE II CLINICAL TRIAL OF PURICASE FOR SEVERE GOUT
SAVIENT COMPLETES PATIENT DOSING IN PHASE II CLINICAL TRIAL OF PURICASE FOR SEVERE GOUT
Savient Pharmaceuticals has completed patient dosing in a Phase II clinical trial of Puricase, a poly(ethylene glycol) (PEG) conjugate of recombinant porcine uricase (urate oxidase), for the treatment of severe, refractory gout.
The Phase II clinical study, an open-label, randomized, multicenter dose-ranging trial involving 41 patients, appears to have reproduced the dramatic, rapid and sustained reduction in plasma uric acid that was seen in the Phase I intravenous study.
Preliminary data suggest that intravenous administration of Puricase every two weeks or every four weeks rapidly achieves and maintains a level of plasma uric acid within the normal range in the majority of patients. The safety profile emerging from the open-label Phase II study appears to be acceptable for proceeding to more extensive patient exposure in a Phase III development program. This study compared three dosage levels and two dosage regimens over a twelve-week period.
KEYWORDS Drug Pipeline Alert
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