Gamma-Hydroxybutyrate (orphan medical)
by
Tunnicliff G, Raess BU.
Indiana University School of Medicine,
Evansville 47712, USA.
gtunnic@iupui.edu
Curr Opin Investig Drugs 2002 Feb;3(2):278-83


ABSTRACT

Orphan Medical is developing gamma-hydroxybutyrate (Xyrem) for the potential treatment of narcolepsy [183352]. In October 2000, an NDA was filed with the FDA [384422], [405504] and Xyrem received an FDA approvable letter in July 2001. Orphan Medical stated that it believed it could meet the requirements in the letter, including a trial in respiratory-compromised patients, by the end of 2001 [414461]. The FDA also requested follow-up safety data from patients in previous Xyrem trials. At that time, the drug was not expected to be launched until mid-2002 [415301], [416305]. In October 1999, the US House of Representatives passed the HR 2130 bill, allowing the medical use of gamma-hydroxybutyrate, which is classified as a Schedule I controlled substance in the US [343562]; the Senate approved this legislation in November 1999 [348206]. In February 2000, a congressional bill supporting the continued development of medically formulated gamma-hydroxybutyrate was passed, making medically formulated gamma-hydroxybutyrate products Schedule III substances [354108], [356597]. GHB occurs naturally in many human tissues. It has previously been used in the treatment of narcolepsy and is not patentable for that indication.
GHB
GABA
MDMA
Opioids
Reward
Alcohol
Dopamine
GHB: structure
GHB withdrawal
GHB and cocaine
Drugs and reward
GHB and the brain
GHB and alcoholism
GHB and narcolepsy
Narcolepsy: a review
GHB (Xyrem): tolerance and withdrawal


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