Xyrem

Bolla KI, McCann UD, Ricaurte GA Memory impairment in abstinent MDMA ( ecstasy ) users. Neurology 51 1532—1537, 1998 Borgen L, Lane E, Lai A Xyrem (sodium oxybate) a study of dose proportionality in healthy human subjects. J Clin Pharmacol 40 1053, 2000 Borgen LA, Okerholm R, Morrison D, et al The influence of gender and food on the pharmacokinetics of sodium oxybate oral solution in healthy subjects. J Clin Pharmacol 43 59-65, 2003... 

Sodium oxybatec Adjunct agents for cataplexy Xyrem 4.5-9 g per night... 

OFFICIAL NAMES Gamma butyrolactone (GBL), dihydro-2(3H)-furanone, 4-butanolide, 2(3H)-furanone dihydro, tetrahy-dro-2-furanone, butyrolactone gamma, gamma hydroxybutyric acid (GHB), 1,4 butanediol (BD tetramethylene glycol Sucol B), sodium oxybate (Xyrem)... 

In 2001, Orphan Medical filed a new drug application with the FDA for a drug called Xyrem (sodium oxy-bate, oral solution), which uses GHB as the active ingredient. In clinical trials, Xyrem has been shown to reduce cataplexy and restore normal sleep patterns. If approved, Xyrem would be the only treatment approved by the FDA as effective in managing cataplexy in people with narcolepsy. 

An FDA Advisory Committee gave majority approval of Xyrem s ability to treat cataplexy in late 2001, although the committee was split regarding the drug s safety. It voted overwhelmingly in support of the need for a risk management plan for the safe use of Xyrem, as Orphan Medical had recommended. 

Some fear exists regarding the abuse of Xyrem, and about how to control distribution in the age of the Internet and on-line pharmacies. Orphan Medical is working with the government to develop a distribution scheme to control prescriptions of Xyrem and limit its use to treat narcolepsy. 

X see Ecstasy X-Trozine see Diet pills Xanax see Benzodiazepine Xenical see Diet pills XTC see Ecstasy Xyrem see GBL... 

The U.S. Xyrem study group (2002) A randomized, double blind, multi center trial comparing the effect of 3 doses of orally administered sodium oxybate with placebo for the treatment of narcolepsy. Sleep 25 42-49... 

Narcolepsy is a rare disease characterized by excessive daytime sleepiness. It has a prevalence of 0.05% in the general population and affects an estimated 140,000 people in the United States. In 2002, the FDA approved sodium oxybate (Xyrem ) for the treatment of cataplexy in patients with narcolepsy. The active ingredient in this drug is gamma hydroxybutyrate, or GHB. The development and marketing of sodium oxybate was permitted after a revision of the Date Rape Prevention Act of 2000 (see Chapter 5) that allowed GHB to be legally administered for medical purposes. 

Because GHB can be abused, carries a risk of possible drug diversion, and presents obvious safety concerns, the FDA set up the Xyrem Risk Management Program. 

In June 2001, a government advisory panel convened by the FDA concluded that GHB could be useful as a treatment for cataplexy, a rare but dangerous complication of the sleep disorder narcolepsy. This panel was asked to consider whether prescription sales should be permitted for GHB under the brand name Xyrem . The committee concluded that the manufacturer of the drug (Orphan Medical) had shown that Xyrem is useful in treating cataplexy, a complication that can cause people to collapse suddenly when their muscles lose strength. 

Federal Drug Administration. (2002). FDA approves Xyrem for cataplexy attacks in patients with narcolepsy. FDA Talk Paper, July 17. 

Xyrem is used as an oral medication, available in solution form, for the treatment of cataplexy in patients with narcolepsy. Gamma hydroxybutyric acid (GHB) is also used as a drug of abuse. 

GHB is absorbed very quickly. After ingestion, it is detected in the serum after 10 min. The maximum plasma concentration is achieved l-2h after exposure. The elimination of the drug is also very rapid and the elimination half-life is 1 h. The removal of GHB occurs via expired carbon dioxide and very little ( 4%) of it is eliminated unchanged in the urine. If Xyrem is taken with food, the bioavailability is greatly reduced while the excretion remains the same. GHB can readily cross the blood-brain barrier and the placenta. 

Primary effects of Xyrem are dose related and include CNS depression, amnesia, and hypotonia (lOmgkg ). Exposures in the range of 20-30 mg kg cause somnolence, drowsiness, dizziness, and euphoria. At levels of 50-70mgkg common symptoms are bradycardia, nausea, and vomiting. Higher exposures can lead to coma. Xyrem may cause neuropsychiatric side effects even at recommended doses. Oral doses as low as 5 g have caused CNS depression. Concurrent alcohol use can delay the onset of symptoms. 

There are no data indicating chronic toxicity due to Xyrem. The potential for abuse of GHB in rhesus monkeys is low. Rats show mild withdrawal symptoms when injected every 3 h for 3-6 days with concentrations GHB that do not cause seizures. 

Symptoms of withdrawal similar to other sedatives have been documented in adults using Xyrem daily. Patients who become dependent on the drug will need supportive care for up to 15 days. 

Because GHB is rapidly absorbed, it will not be detected in most routine toxicology screenings. Further, gastric lavage with activated charcoal will not be helpful. Intubation and mechanical ventilation may be needed in patients with CNS depression. There is no antidote for Xyrem intoxication and treatment is based on the symptoms present. 

Xyrem is a liquid with a GHB concentration of 0.5 gmH The total daily dose for patients who are... 

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