Jazz Pharmaceuticals Announces European Commission Marketing Approval of Xyrem
Posted on: Thursday, 8 December 2005, 18:00 CST
PALO ALTO, Calif., Dec. 8 /PRNewswire/ -- Jazz Pharmaceuticals, Inc. announced today that the European Commission has granted marketing approval in the European Union of Xyrem(R) (sodium oxybate) oral solution for the treatment of cataplexy in adult patients with narcolepsy. Xyrem is marketed in the European Union by UCB, which today announced the product's availability in Germany.
"Xyrem will be the first and only drug approved in Europe for the treatment of cataplexy in patients with narcolepsy. We are pleased that this important therapy will now be available to physicians and patients in Europe," said Robert M. Myers, Chief Business Officer of Jazz Pharmaceuticals.
Narcolepsy is a debilitating neurological disorder. Cataplexy is a typical symptom of narcolepsy, second in frequency only to excessive daytime sleepiness. Cataplexy is a sudden loss of control over voluntary muscles, usually triggered by emotions such as amusement, anger, arousal or fear. Severe cataplexy attacks can cause complete postural collapse.
About Xyrem in the United States
Xyrem is approved by the U.S. Food and Drug Administration (FDA) for the treatment of cataplexy and excessive daytime sleepiness in patients with narcolepsy. Xyrem is marketed in the United States by Jazz Pharmaceuticals through its wholly-owned subsidiary, Orphan Medical.
Xyrem is a Schedule III drug under the Controlled Substances Act and is only available through a restricted distribution system called the Xyrem Success Program(R). Please refer to the Xyrem package insert ( http://www.xyrem.com/ ) for full prescribing information. Sodium oxybate, the active ingredient in Xyrem, is a sodium salt of gamma-hydroxybutyrate, a substance with a history of abuse when acquired illicitly and used illegally. Abuse of illicit gamma-hydroxybutyrate has been associated with adverse CNS events including seizures, respiratory depression and profound decreases in level of consciousness, with instances of coma and death.
About Jazz Pharmaceuticals, Inc.
Jazz Pharmaceuticals is focused on helping patients by meeting unmet medical needs in neurology and psychiatry with important and innovative therapeutic products. Jazz Pharmaceuticals is aggressively building its product portfolio through a combination of commercialization and development activities. Based in Palo Alto, California, the company is committed to working closely with patients, patient advocacy groups and healthcare professionals. For further information, visit http://www.jazzpharmaceuticals.com/ .
Contacts: Mark Leonard 847-267-9660 markdleonard@comcast.net Jazz Pharmaceuticals, Inc. Matthew Fust Chief Financial Officer 650-496-3777 mediainfo@jazzpharma.com
Jazz Pharmaceuticals
CONTACT: Mark Leonard of Next Level Communications, +1-847-267-9660, ormarkdleonard@comcast.net ; or Matthew Fust, Chief Financial Officer of JazzPharmaceuticals, Inc., +1-650-496-3777, or mediainfo@jazzpharma.com
Web site: http://www.jazzpharmaceuticals.com/http://www.xyrem.com/
Source: PRNewswire
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