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Searle’s Daypro (oxaprozin)

Executive Summary

Phase IV commitments include two efficacy trials: a placebo- controlled or low-dose controlled study replicating the existing active-control studies of oxaprozin in osteoarthritis; and a fixed-dose trial of oxaprozin doses up to 1,800 mg/day. The studies of the new NSAID, approved on Oct. 29, are to be completed within two years. In addition, FDA has asked the company to complete within two years five studies including: in vitro and in vivo protein binding of oxaprozin; population pharmacokinetics; drug interactions; oxaprozin in patients with renal dysfunction; and multiple-dose, dose-proportionality and pharmacokinetic studies of free and bound oxaprozin in doses ranging from 600- 1,800 mg.
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PS021754

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