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Xyrem

Gamma-hydroxybutyrate (4-hydroxybutanoic acid, C₄H₈O₃) is both a drug and a naturally occurring compound found in the central nervous system as well as in other organs as liver, kidneys, heart and bones. GHB is structurally similar to the ketone body beta-hydroxybutyrate. As a drug it is used most commonly in the form of a chemical salt (Na-GHB or K-GHB). The sodium salt is commercially known as sodium oxybate. more...

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Xyrem

Uses

Endogenous

The precise function of GHB in body is not clear. It is an immediate precursor to GABA, a neurotransmitter which regulates awakeness, physical activity and sleep. As GABA cannot cross blood-brain barrier, GHB obtained from food may be used for converting to GABA. GHB prevents cells from oxygen starvation, which might explain presence of the compound in vital organs. GHB was also found to have neuroprotective capabilities.

Medical

It has been used as a general anesthetic, and a hypnotic in the treatment of insomnia. GHB has also been used to treat clinical depression, and improve athletic performance. In the United States, the Food and Drug Administration permits the use of GHB under the trade name Xyrem to reduce the number of cataplexy attacks in patients with narcolepsy.

Recreational

GHB is an intoxicant. It may be known as G, Liquid X, Liquid E. It is less commonly known as GBH, Gamma-oh, Georgia Homeboy, Blue Verve, Gamma-G, Qi, scoop, goop, Grievous Bodily Harm, or Get Hospitalised Bitch.

Its potential for use as a date rape drug in the 1990s led to it being placed in the US on Schedule I of the Controlled Substances Act in March, 2000. On March 20, 2001, the Commission on Narcotic Drugs placed GHB in Schedule IV of the 1971 Convention on Psychotropic Substances. In the UK it was made a class C drug in June 2003.

The sodium salt of GHB has a thin, very salty, chemical taste. At low doses, GHB can cause a state of euphoria, increased sociality and intoxication. This kind of use is particularly common at rave parties. At higher doses, GHB may induce nausea, dizziness, drowsiness, visual disturbances, depressed breathing, amnesia and unconsciousness. The effects of GHB can last from 1.5 to 3 hours.

Some chemicals convert to GHB in the stomach and blood. GBL, or gamma-butyrolactone, is one such precursor. It is 1,6 times more potent than GHB, so 1ml of GBL is equivalent to 0,4g of GHB. GBL has also a shorter onset and is longer acting than GHB. GBL has an extremely bad taste and is also known to irritate innards and skin.

Other precursors include 1,4-butanediol. There may be additional toxicity concerns with these precursors.

Mode of action

The action of GHB has yet to be fully elucidated. GHB clearly has at least two sites of action, stimulating the newly characterized and aptly named "GHB receptor" as well as the GABA_B. GHB, if it is indeed a neurotransmitter, will only reach concentrations high enough to act at the GHB receptor, as it only has weak affinity fo the GABA_B. However, during recreational usage, GHB can reach very high concentrations in the brain, relative to basal levels, and can act at the GABA_B receptor . GHBs action at the GABA_B is probably responsible for its sedative effects. GHB-mediated GABA_B receptor stimulation inhibits dopamine release as well as causes the release of natural sedative neurosteroids (like all other GABA_B agonists e.g. Baclofen). In animals GHBs sedative effects can be stopped by GABA_B antagonists (blockers).

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Xyrem(R) is Launched in Germany for the Treatment of Cataplexy in Adults with Narcolepsy
From Market Wire, 12/8/05

Brussels, Belgium - December 8, 2005: UCB announced today that Xyrem® (sodium oxybate) oral solution is now available in Germany for the treatment of cataplexy in adult patients with narcolepsy. Launch in this first major European market follows the recent European Commission (EC) marketing approval of Xyrem® in this orphan indication, with pan-European commercialisation expected over 2006.

"Xyrem® provides physicians and patients in Europe with the first and only EMEA approved medication for the treatment of cataplexy in patients with narcolepsy. We are delighted to serve European physicians and sleep centres with a product that can help fulfil the unmet medical need in patients with this serious sleep disorder." said Emmanuel Caeymaex, Vice-President, Marketing CNS, UCB.

Narcolepsy is a debilitating, life-long neurological disorder that is characterised by excessive daytime sleepiness and sleep attacks[1]. Cataplexy is a typical symptom of narcolepsy and is present in 65-70% of patients with narcolepsy. It involves a sudden reversible loss of muscle tone, usually triggered by emotional stimuli such as laughter, excitement, surprise and anger, with contributing factors including physical fatigue, stress or sleepiness[2]. Commenting on the marketing approval Adrian Williams MD of Sleep Centre, St. Thomas Hospital, London, UK said "Patients and physicians in the EU should be encouraged by the body of clinical research supporting Xyrem®. In Europe, the approval of Xyrem® for the treatment of cataplexy in patients with narcolepsy provides a welcome addition to the pharmacological armamentarium."

Notes to Editor

1. UCB acquired the licence to distribute Xyrem® in Europe from Orphan Medical recently acquired by Jazz Pharmaceuticals). Xyrem® is marketed in the U.S. by Jazz Pharmaceuticals and has been available in the U.S. since 2002.

2. Orphan medicinal product designation

Xyrem® was designated as an orphan medicinal product on February 3, 2003. Orphan medicinal products are used to diagnose, prevent or treat life-threatening or very serious conditions that are rare, with a prevalence of less than five per 10,000 of the EU population. European orphan drug designation enables recipient sponsors to receive regulatory guidance in the drug development process and allows for up to 10 years of European market exclusivity for the designated indication upon approval of the market application.

3. Clinical trials

The European marketing approval of Xyrem® was mainly based on a prospective, multicentre, randomized, double-blind, placebo-controlled trial that examined the safety and efficacy of Xyrem® (3 g, 6 g and 9 g) for the treatment of narcolepsy symptoms. Xyrem® was taken in divided nightly doses immediately before bed-time and repeated 2oe-4 hours later. Results of this four-week study showed that in comparison to placebo, Xyrem® demonstrated clinical improvements in the reported number of weekly cataplexy attacks and daytime sleepiness. Investigators assessed changes in disease severity using the Clinical Global Impression of change (CGI-c) measure, and Xyrem® (9 g) was found to significantly decrease the frequency of cataplexy attacks compared to placebo[1].

A follow-up, 12-month open-label study showed that Xyrem® (3-9 g) was well-tolerated and produced significant and long-term clinical improvement in the frequency of cataplexy attacks and diminished day-time sleepiness[3].

About UCB

UCB (www.ucb-group.com) is a global biopharmaceutical leader with headquarters in Brussels, Belgium, specialising in the fields of central nervous system disorders, inflammatory diseases, and oncology. UCB key products are Keppra® (antiepileptic), Xyzal® and Zyrtec® (antiallergics), Nootropil® (cerebral function regulator), Tussionex® (antitussive) and Metadate(TM) / Equasym XL(TM) (attention deficit/hyperactivity disorder). UCB employs over 8,500 people operating in over 40 countries. UCB is listed on Euronext Brussels (UCB / UCBBt.BR / UCB BB).

[1] The U.S. Xyrem® Multicenter Study Group A randomized, double-blind, placebo controlled multi-centre trial comparing the effects of three doses of orally administered sodium oxybate with placebo for the treatment of narcolepsy Sleep 2002: 25 (1), 42-49

[2] http://www.sleepfoundation.org/sleeptionary/index.php?id=12&subsection=symptomsaccessed November 6, 2005

[3] The U.S. Xyrem® Multicenter Study Group A 12-month, Open-Label, Multicenter Extension Trial of Orally Administered Sodium Oxybate for the Treatment of Narcolepsy Sleep 2003: 26 (1), 31-35

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