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Xyrem for excessive daytime sleepiness

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Orphan Medical expects to file sNDA in second-half 2004 for use of Xyrem (sodium oxybate) in the treatment of excessive daytime sleepiness (EDS) associated with narcolepsy. Enrollment is complete for one of two pivotal EDS trials, the firm says March 24. The 200-patient Phase IIIb SXB-15 study is evaluating Xyrem in combination with stimulants. A second trial (EXCEEDS), looking at the relative efficacy of Xyrem with or without modafinil (Cephalon's Provigil), "is nearing completion as well." The supplemental indication would "allow [for] the posi tioning of Xyrem as a medication that effectively addresses the full range of narcolepsy symptoms," CEO John Bullion says...
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