Orphan Medical Xyrem safety data

Safety data on Orphan Medical's Xyrem (sodium oxybate) in respiratory-compromised patients may be collected post-approval if FDA accepts submission of data on that patient population from an earlier trial, Orphan says. A July 2 "approvable" letter for the narcolepsy treatment indicated that a study would be required before approval. Orphan plans to file the additional data in mid-November and expects a six-month review