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Orphan Medical Xyrem FDA Study Request Could Delay Launch Until Mid-2002

Executive Summary

Orphan Medical's launch for its narcoleptic cataplexy treatment Xyrem could be delayed until mid-2002 by an FDA request for a study of respiratory-compromised patients.

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Orphan Medical Xyrem Is “Approvable” Pending FDA Trial Site Review

FDA will conduct a clinical trial site review before approving Orphan Medical's narcoleptic cataplexy agent Xyrem, the company said following receipt of an "approvable" letter April 9

Orphan Medical Xyrem Is “Approvable” Pending FDA Trial Site Review

FDA will conduct a clinical trial site review before approving Orphan Medical's narcoleptic cataplexy agent Xyrem, the company said following receipt of an "approvable" letter April 9

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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