Full Prescribing Information Important Safety Information Medication Guide

History of XYREM®

What Is an Orphan Drug?

Orphan drugs are given special status by the government due to the rarity of the conditions they treat. Because these diseases are so rare, the market for them is small, making orphan drugs economically undesirable to produce. Government assistance, via tax breaks, subsidy for research, and exclusivity gives companies the incentive to produce these drugs.[1]
In 1983, the United States legislature enacted the Orphan Drug Act, with the aim of encouraging drug companies to provide a home for promising treatments for such disorders. The government offers incentives to encourage manufacturers to develop and market drugs that might not have been developed otherwise.[2]
These drugs go through the normal FDA approval process. Once an orphan drug is approved for marketing, a doctor may prescribe it to his or her patients. If the drug is still in the experimental stage, the manufacturer may make it available to individuals on a compassionate-use basis, or individuals may be able to enroll in a clinical trial.[1]

Timeline to FDA Approval


Do not take XYREM if you:

  • take other sleep medicines or sedatives (medicines that cause sleepiness)
  • drink alcohol
  • have a rare problem called succinic semialdehyde dehydrogenase deficiency.
To reach the pharmacy by phone please call:

 1-866-997-3688

To report a side effect
please call:

 1-800-520-5568


Jake S - Mentor

Talk with a XYREM Patient Connection Mentor

The XYREM Patient Connection program provides an opportunity for you to talk one-on-one with a mentor who has been diagnosed with excessive daytime sleepiness and/or cataplexy with narcolepsy, and has been treated with XYREM.

References:

  1. ^ US Food and Drug Administration. The Orphan Drug Act (as amended). Available at: http://www.fda.gov/orphan/oda.htm. Accessed September 13, 2011.
  2. ^ Neuman A. GHB’s path to legitimacy: an administrative and legislative history of Xyrem. Harvard Law School Legal Electronic Document Archive. http://leda.law.harvard.edu/leda/data/629/Neuman.html. 2004. Accessed March 3, 2010
  3. ^ US Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21196ltr.pdf. Accessed August 29, 2011.
  4. ^ US Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021196s005ltr.pdf. Accessed August 29, 2011.
  5. ^ Data on File Jazz Pharmaceuticals, Inc.
  6. ^ Xyrem® (sodium oxybate) [prescribing information]. Palo Alto, CA: Jazz Pharmaceuticals, PLC.; 2012.
    The product information provided in this site is intended for residents of the United States only.