Around the same time, reports began to surface
women dying or being sexually assaultedafter illegal GHB was slipped into their drinks.
In 2000, alarmed by these reports, Congressmade a rare departure from its traditional stance
leaving drug scheduling to the executivebranch, and passed the Hillory
Farias and Samantha Reid Date-Rape Drug Prohibition Act,which bifurcated controlled substance scheduling for GHB.
The law made GHB a Schedule Idrug,
but also provided that an FDA-approved drug containing GHB could be listed as aSchedule III drug.
At the time
bill's passage, the FDA had not approved Xyrem.Two years later, following successful clinical trials, the FDA approved Xyrem for the treatment
cataplexy in patients with narcolepsy .
And, in 2005, three years after its initial approval,the FDA approved Xyrem for the treatment
EDS in patients with narcolepsy .
Today, Xyrem remains the only FDA-approved treatment for cataplexy, one
the mostdisabling features
and it enables patients suffering from this symptom to resumea more normal life.
Patients taking Xyrem also get relief from EDS, a ubiquitous and,typically, severe feature
narcolepsy that has been associated with an array
negativepsychosocial and emotional effects, such as difficulty with interpersonal
andtrouble maintaining employment.
Xyrem's unique risks led the FDA to restrict its use.
Recognizing that Xyrem presented unique and substantial risks, the FDA approved the drug
Nicholson KL, Balster RL. GHB: a new and novel drug
Drug Alcohol Depend.
2001 Jun 1;63(1):1-22.Review.
Schwartz RH, Milteer
LeBeau MA. Drug-facilitated sexual assault ('date rape').
2000 Jun;93(6):558-61. Review.
Farias and Samantha Reid Date-Rape Drug Prohibition Act
No. 106-172, 114 Stat. 7(2000).
Schedule I controlled substances have a high potential for abuse, have no currently accepted medical use intreatment
the U.S., and there
accepted safety for their use under medical supervision.
Hillory J. Farias and Samantha Reid Date-Rape Drug Prohibition Act
No. 106-172, 114 Stat. 7,sec. 3(a)(l )(B) (2000);
Letter from David Satcher, Asst. Secretary for Health and Surgeon General, HHS toDonnie
Marshall, Deputy Administrator, DEA (May 19, 1999),
http://www deadiversion. usdoj .gov fed_regs/rules/2000/fr0313 .htm.
See Xyrem Approval Letter #I.
Letter from Russell Katz, Dir. Division
Neurology Products, COER to Orphan Medical, sNDA ApprovalLetter for Xyrem, NDA 21-196/S-005 (Nov. 18, 2005) [hereinafter
Xyrem Approval Letter
CLINICAL ADULT NEUROLOGY
Vie! G, Montagnese
Raduazzo DI, Ferrara SD, Dauvilliers Y. Narcolepsy andeffectiveness
gamma-hydroxybutyrate (GHB): A systematic review and meta-analysis
Sleep Med Rev.
Broughton WA, Broughton RJ. Psychosocial Impact ofNarcolepsy,
1994 Dec; 17(8Suppi):S45-9.Review.
Roger Broughton & Quais Ghana,
Impact ofCompound Narcolepsy on the Life
20 I, 201-20 (Christian Guilleminault
eds., 1976) ("[Narcolepsy] frequently leads tovery disturbing visual problems, memory difficulties, an extremely bad driving record, recurrent household andsmoking accidents, poor productivity, blocking
promotion, decreased hearing capacity and even
dismissal,personality changes including a striking tendency to depression even to suicidal levels, hallucinations and paranoia,difficulties and embarrassment
both education and recreation, loss
and (for males) impotence,miscellaneous disturbance
balance, bizarre dysesthesias, terrifying dreams, headaches, and the danger
life through accident or drowning.").