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STUDY RESULTS WITH XYWAV

Study results for XYWAV in adults with Idiopathic Hypersomnia (IH)


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  • XYWAV vs placebo
  • Study results
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A clinical study of nightly XYWAV showed that, compared to placebo (a treatment that is inactive), XYWAV:

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Helped treat excessive daytime sleepiness

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Helped with overall Idiopathic Hypersomnia symptoms (patient reported)

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Helped with the severity and frequency of Idiopathic Hypersomnia symptoms like long sleep time, cognitive impairment, and sleep inertia

What changes in excessive daytime sleepiness were seen in people during the XYWAV clinical study?

  • Excessive daytime sleepiness (EDS) is measured by a screener called the Epworth Sleepiness Scale (ESS).
  • The ESS measures EDS on a scale from 0 to 24.
Epworth Sleepiness Scale diagram

Note: The information collected during the first part of the study was not meant to measure how well XYWAV worked.

Stable dose = the dose of XYWAV that worked best for each person.

ESS study results

Results shown here used average scores, which were then rounded up or down. That’s why the difference between scores may not always appear to add up.

Not sure of your ESS score?

Find out your level of daytime sleepiness and be sure to share your results with your doctor.

Download ESS

Source: Johns MW. A new method for measuring daytime sleepiness: the Epworth Sleepiness Scale. Sleep.1991;14(6):540-545.

The Epworth Sleepiness Scale (ESS) is intended to measure EDS, a symptom of Idiopathic Hypersomnia. It is not intended to make an Idiopathic Hypersomnia diagnosis.

What changes in overall Idiopathic Hypersomnia symptoms were seen in people during the XYWAV clinical study?

  • The Patient Global Impression of Change (PGIc) screener was used to measure how well XYWAV helps treat symptoms of Idiopathic Hypersomnia overall.
  • The PGIc asked participants to rate how their Idiopathic Hypersomnia felt using a 7-point scale ranging from “very much improved” to “very much worse.”
Patient Global Impression of Change study results

Worsening was defined as “minimally, much worse, or very much worse” Idiopathic Hypersomnia overall. Improvement was defined as “minimally, much improved, or very much improved” Idiopathic Hypersomnia overall.

What changes in Idiopathic Hypersomnia symptoms were seen in people during the XYWAV clinical study?

  • Severity and frequency of Idiopathic Hypersomnia symptoms is measured by a screener called the Idiopathic Hypersomnia Severity Scale (IHSS).
  • The IHSS is a unique screener—it is the only one validated to measure Idiopathic Hypersomnia symptoms.
  • The IHSS asks participants to answer 14 questions related to the frequency and intensity of a range of symptoms—including excessive sleepiness, long sleep time, cognitive impairment, and sleep inertia.
  • The IHSS measures frequency and severity of Idiopathic Hypersomnia symptoms on a scale of 0 to 50.
Idiopathic Hypersomnia severity scale results

Note: The information collected during the first part of the study was not meant to measure how well XYWAV worked.

Stable dose = the dose of XYWAV that worked best for each person.

IHSS study results

Results shown here used average scores, which were then rounded up or down. That’s why the difference between scores may not always appear to add up.

Do you know your IHSS score?

Rate the severity and frequency of your Idiopathic Hypersomnia symptoms and be sure to share your results with your doctor.

Source: Dauvilliers Y, Evangelista E, Barateau L, et al. Measurement of symptoms in idiopathic hypersomnia: the Idiopathic Hypersomnia Severity Scale. Neurology. 2019;92(15):e1754-e1762.

The Idiopathic Hypersomnia Severity Scale is intended to measure the frequency and severity of Idiopathic Hypersomnia symptoms. It is not intended to make an Idiopathic Hypersomnia diagnosis.

Learn more

XYWAV® (calcium, magnesium, potassium, and sodium oxybates) oral solution, 0.5 g/mL total salts (equivalent to 0.413 g/mL of oxybate) is a prescription medicine used to treat:

  • the following symptoms in people 7 years of age or older with narcolepsy:
    • sudden onset of weak or paralyzed muscles (cataplexy)
    • excessive daytime sleepiness (EDS)
  • idiopathic hypersomnia (IH) in adults.

Important Safety Information

WARNING: Taking XYWAV with other central nervous system (CNS) depressants such as medicines used to make you or your child fall asleep, including opioid analgesics, benzodiazepines, sedating antidepressants, antipsychotics, sedating anti-epileptic medicines, general anesthetics, muscle relaxants, alcohol, or street drugs, may cause serious medical problems, including trouble breathing (respiratory depression), low blood pressure (hypotension), changes in alertness (drowsiness), fainting (syncope), and death.

The active ingredient of XYWAV is a form of gamma-hydroxybutyrate (GHB). Abuse or misuse of illegal GHB alone or with other drugs that cause changes in alertness (or consciousness) has caused serious side effects. These effects include seizures, trouble breathing (respiratory depression), changes in alertness (drowsiness), coma, and death. Call your doctor right away if you or your child has any of these serious side effects.

Because of these risks, you have to go through the XYWAV and XYREM REMS to have your or your child's prescription for XYWAV filled.

Do not take XYWAV if you take or your child takes other sleep medicines or sedatives (medicines that cause sleepiness), drinks alcohol, or has a rare problem called succinic semialdehyde dehydrogenase deficiency.

Keep XYWAV in a safe place to prevent abuse and misuse. Selling or giving away XYWAV may harm others, and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.

Anyone who takes XYWAV should not do anything that requires them to be fully awake or is dangerous, including driving a car, using heavy machinery, or flying an airplane, for at least 6 hours after taking XYWAV. Those activities should not be done until you know how XYWAV affects you or your child.

XYWAV can cause serious side effects, including the following:

  • Breathing problems, including slower breathing, trouble breathing, and/or short periods of not breathing while sleeping (sleep apnea). People who already have breathing or lung problems have a higher chance of having breathing problems when they use XYWAV.
  • Mental health problems, including confusion, seeing or hearing things that are not real (hallucinations), unusual or disturbing thoughts (abnormal thinking), feeling anxious or upset, depression, thoughts of killing yourself or trying to kill yourself, increased tiredness, feelings of guilt or worthlessness, or difficulty concentrating. Tell your doctor if you or your child have or had depression or have tried to harm yourself or themselves. Call your doctor right away if you have or your child has symptoms of mental health problems or a change in weight or appetite.
  • Sleepwalking. XYWAV can cause sleepwalking, which can cause injuries. Call your doctor if this occurs.

The most common side effects of XYWAV in adults include nausea, headache, dizziness, anxiety, insomnia, decreased appetite, excessive sweating (hyperhidrosis), vomiting, diarrhea, dry mouth, parasomnia (a sleep disorder that can include abnormal dreams, abnormal rapid eye movement (REM) sleep, sleep paralysis, sleep talking, sleep terror, sleep-related eating disorder, sleepwalking, and other abnormal sleep-related events), somnolence, fatigue, and tremor.

The most common side effects of XYREM (which also contains oxybate like XYWAV) in children include nausea, bedwetting, vomiting, headache, weight decrease, decreased appetite, dizziness, and sleepwalking.

XYWAV can cause physical dependence and craving for the medicine when it is not taken as directed. These are not all the possible side effects of XYWAV.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see full Prescribing Information, including BOXED Warning, and Medication Guide.

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