Xyrem Sodium

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... 

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. 

Borgen, L.A., Lai, A. and Okerholm, R.A. (2001). Xyrem (sodium oxybate) the effects of gender and food on plasma kinetics. Orphan Medical, Inc., Minnetonka, MN, personal communication. 

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)... 

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. 

Gamma-hydroxybutyrate, sodium salt CASRN 502-85-2 C4H7Na03 MW 126.09 Prescription drug formulations sodium oxybate (generic name) Gamma OH (France) Somsanit (Germany) Alcover (Italy) and Xyrem (United States) ... 

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