Cataplexy

XYREM^® significantly reduces cataplexy attacks in narcolepsy[1][2]

Trial 1: From a 4-week, double-blind, placebo-controlled trial of narcolepsy patients (N=136) with moderate to severe cataplexy (median of 21 attacks per week). Patients continued to receive stable stimulant therapy throughout the study.

Up to 69% reduction in cataplexy attacks

The effective dose range of XYREM is 6 to 9 g/night

Discontinuation of XYREM does not result in rebound cataplexy[3]

Trial 2: From an open-label treatment period averaging 21 months (range 7 to 44 months), after which patients were randomized to XYREM or placebo for a 2-week, double-blind discontinuation trial (N=55).

Reassurance for patients who occasionally miss a dose.
Patients switched to placebo experienced a median increase of 21 attacks gradually over the 2-week period (p<0.001).

Gradual Return of Cataplexy

The reduction in cataplexy attacks was maintained after an average of 21 months of XYREM use[2][3]

Patients who remained on XYREM showed no median increase in cataplexy attacks.

References:

^ The US XYREM® Multicenter Study Group. A randomized, double blind, placebo-controlled multicenter trial comparing the effects of three doses of orally administered sodium oxybate with placebo for the treatment of narcolepsy. Sleep. 2002;25:42–49.
^ XYREM® (sodium oxybate) [prescribing information]. Palo Alto, Calif: Jazz Pharmaceuticals; 2005.
^ The US XYREM® Multicenter Study Group. Sodium oxybate demonstrates long-term efficacy for the treatment of cataplexy in patients with narcolepsy. Sleep Med. 2004;5:119–123.

Important Safety Information

1. XYREM^® is a controlled substance. Controlled substances are medicines that, if abused, may lead to varying degrees of physical or psychological dependence. XYREM is a Schedule III drug — which means that it has a moderate dependence liability. If you sell, distribute, or give your XYREM to anyone else or use it for purposes other than what it was prescribed for, you may be punished under federal and state law by jail and fines.

2. It is very important to keep XYREM out of reach of children and pets.

3. XYREM can cause serious side effects including trouble breathing while asleep, confusion, abnormal thinking, depression and loss of consciousness. Tell your doctor if you have any of these problems while taking XYREM.

BOXED WARNING:

!Warning

Central Nervous System Depressant with Abuse Potential. Should not be used with alcohol or other CNS depressants. Sodium oxybate is a form of GHB, a known drug of abuse. Abuse has been associated with some important central nervous system (CNS) adverse events (including death). Even at recommended doses, use has been associated with confusion, depression, and other neuropsychiatric events. Reports of respiratory depression occurred in clinical trials. Almost all of the patients who received sodium oxybate during clinical trials were receiving CNS stimulants.

Important CNS adverse events associated with abuse of GHB include seizure, respiratory depression and profound decreases in level of consciousness, with instances of coma and death. For events that occurred outside of clinical trials, in people taking GHB for recreational purposes, the circumstances surrounding the events are often unclear (e.g., dose of GHB taken, the nature and amount of alcohol or any concomitant drugs).

XYREM is available through the XYREM Success Program^®, using a centralized pharmacy 1-866-XYREM88^® (1-866-997-3688). The Success Program provides educational materials to the prescriber and the patient explaining the risks and proper use of sodium oxybate, and the required prescription form. Once it is documented that the patient has read and/or understood the materials, the drug will be shipped to the patient. The XYREM Success Program also recommends patient follow-up every 3 months. Physicians are expected to report all serious adverse events to the manufacturer.