NEW FDA APPROVAL

Now FDA approved to treat excessive daytime sleepiness (EDS) in children 6 years of age and older with narcolepsy.

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EDS & Cataplexy in Adults

Chris - Living with narcolepsy Taking WAKIX since 2021
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Results With WAKIX in the Adult Clinical Trials

Significantly reduced excessive daytime sleepiness (EDS) and significantly fewer cataplexy attacks in adults with narcolepsy compared with placebo

EDS Results
Cataplexy Results
Side Effects

EDS Results

WAKIX significantly reduced excessive daytime sleepiness (EDS) compared with placebo

WAKIX was studied for the treatment of EDS in two clinical trials (Trial 1 and Trial 2) in 159 adult patients with narcolepsy. WAKIX was compared with placebo (sugar pill) using the Epworth Sleepiness Scale (ESS)A questionnaire that measures the level of EDS by seeing how likely you are to doze or fall asleep in 8 everyday situations..

  • Trial 1 was 8 weeks and included 61 adults with narcolepsy with or without cataplexy (31 people were treated with WAKIX and 30 received placebo). About 80% of the people in the trial had cataplexy and about 20% did not.
  • Trial 2 was also 8 weeks and included 98 adults with narcolepsy with or without cataplexy (66 people were treated with WAKIX and 32 received placebo). In this trial, 75% of people had cataplexy and 25% did not.

At the start of the trials, the majority of patients reported severe EDS

Their ESSEpworth Sleepiness Scale (ESS): A questionnaire that measures the level of EDS by seeing how likely you are to doze or fall asleep in 8 everyday situations. scores were 16 or higher, which means they had a high chance of dozing or falling asleep in everyday situations, such as:

Falling asleep while reading icon

Reading

Falling asleep while watching TV icon

Watching TV

Falling asleep while talking to someone icon

Sitting and talking

At the end of the trials…

  • Reduced sleepiness icon

    ESS scores were significantly improved for patients taking WAKIX compared with placebo

    This means patients taking WAKIX reported a significantly lower ESS score, or lower chance of dozing or falling asleep in everyday situations compared with placebo.

  • Everyone responds to medication differently. Individual responses varied in the clinical trials.

Cataplexy Results

Significantly fewer cataplexy attacks with WAKIX compared with placebo

WAKIX was studied for the treatment of cataplexy in two clinical trials (Trial 3 and Trial 1) in 154 adult patients with narcolepsy. WAKIX was compared with placebo (sugar pill) by measuring how often patients in the trials experienced cataplexy. One trial measured the number of weekly cataplexy attacks and the other trial measured the number of daily cataplexy attacks.

  • Trial 3 was 7 weeks and included 105 adults with narcolepsy with cataplexy (54 people were treated with WAKIX and 51 received placebo). This trial measured the number of weekly cataplexy attacks.
  • Trial 1 was 8 weeks and included 49 adults with narcolepsy with cataplexy (25 people were treated with WAKIX and 24 received placebo). This trial measured the number of daily cataplexy attacks.

At the start of the trial measuring weekly cataplexy attacks, on average, patients had about 8 cataplexy attacks per week

Examples of cataplexy include:

Knees buckling cataplexy icon

Knees buckling

Hand weakness cataplexy icon

Hand weakness(dropping objects)

Jaw sagging cataplexy icon

Jaw sagging

At the end of this trial…

  • Reduced cataplexy attacks icon

    Patients taking WAKIX had about half as many cataplexy attacks per week compared with patients taking placebo

Everyone responds to medication differently. Individual responses varied in the clinical trials.

Side Effects

WAKIX side effects in the adult clinical trials

In clinical trials of adult patients with narcolepsy, the most common side effects of WAKIX that were at least twice the rate of placebo (sugar pill) were:

Insomnia icon

Insomnia

Nausea icon

Nausea

Anxiety icon

Anxiety

Side effects that occurred in at least 5% of patients treated with WAKIX and more frequently than placebo

Table showing side effects of WAKIX in clinical trialsTable showing side effects of WAKIX in clinical trials

n indicates the number of patients who were treated with WAKIX or received placebo.

  • WAKIX clinical trials icon

    Other side effects of WAKIX in the adult clinical trials included increased heart rate, hallucinations, irritability, abdominal pain, sleep disturbance, and decreased appetite.

  • Talk bubble icon

    These are not all the possible side effects of WAKIX. Tell your healthcare provider about any side effect that is bothersome or that does not go away.

Infographic showing discontinuation rates in adult clinical trials
See results in children 6-17 years old