FDA panel votes in favor of Orphan's Xyrem

7 June 2001

The US Food and Drug Administration's Peripheral and Central NervousSystem Drugs Advisory Committee has voted to recommend approval of Orphan Medical's Xyrem (sodium oxybate) oral solution, a drug which contains the active ingredient gamma hydroxybutyrate and is notoriously abused as a date-rape drug, for reducing the incidence of cataplexy associated with narcolepsy.

The panel voted with a majority of six to three in support of approving the 9mg/day dose, and five to four for 6mg/day. It was also tied four to four (with one abstention) on the issue of safety, and voted eight to one that a risk-management plan is necessary for the safe use of Xyrem, as was recommended by the company. To minimize the abuse potential of the drug, Orphan has promised to limit the manufacturing to a single site, and also requires prescriptions be sent overnight to patients from a central pharmacy.

The company's chief executive, John Bullion, said that he was "encouraged by the outcome of the committee's deliberations, even though the voting was not unanimous. We will meet promptly with the FDA and feel confident we can address the clinical issues discussed by the committee."

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