Orphan Medical responds to Xyrem "approvable" letter
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Orphan Medical submits Xyrem (sodium oxybate) NDA amendment Oct. 8 in response to FDA's July 2 "approvable" letter for the narcolepsy treatment. The amendment includes "revisions to product labeling and the risk management program, a safety update of ongoing clinical trials, and respiratory data collected during all night polysomnographic recordings of narcolepsy patients in a trial completed in early 2001," the firm says. The respiratory data were included to "address FDA's concern that Xyrem might have a depressant effect on respiration." The company has agreed to conduct a post-marketing trial on acute exposure in respiratory-compromised patients