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Orphan Medical Xyrem safety data

Executive Summary

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

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Orphan Medical responds to FDA

Orphan Medical's Xyrem (sodium oxybate) will be distributed through a single mail-order pharmacy under a risk management plan proposed in the company's Oct. 9 response to FDA's July 2 "approvable" letter for the narcoleptic cataplexy treatment (1"The Pink Sheet" July 9, p. 18). Orphan's response includes respiratory data from an earlier trial in place of a pre-approval study on respiratory-compromised patients (2"The Pink Sheet" Sept. 3, In Brief). Company's risk management program also calls for a prescription registry and special Xyrem prescribing pads; FDA has six months to act on the response

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