WAKIX was studied for the treatment of excessive daytime
sleepiness (EDS) and cataplexy in adults with narcolepsy.
WAKIX Reduced Excessive Daytime Sleepiness
WAKIX was studied for the treatment of EDS in two clinical trials in 159 adults with narcolepsy.
- WAKIX was compared with placebo (sugar pill) using a questionnaire called the Epworth Sleepiness Scale (ESS)
- The ESS measures the level of EDS by seeing how likely you are to doze or fall asleep in 8 everyday situations
- In the trials, 97 people were treated with WAKIX and 62 people received placebo
At the start of the trials...
The majority of patients reported severe EDS. Their ESS scores were 16 or higher, which means they had a high chance of dozing or falling asleep in everyday situations, such as:
Sitting and talking
At the end of the trials...
WAKIX showed significantly greater improvement in ESS score 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 patients taking placebo.
Everyone responds to medication differently. Individual responses varied in the clinical trials
Trial 1 and Trial 2 were the clinical trials for EDS.
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.
Fewer Cataplexy Attacks With WAKIX
WAKIX was studied for the treatment of cataplexy in two clinical trials in 154 adults with narcolepsy.
- WAKIX was compared with placebo (sugar pill) by measuring how often patients in the trials experienced cataplexy. Cataplexy was defined as sudden muscle weakness often triggered by emotions
- One trial measured the number of weekly cataplexy attacks and the other trial measured the number of daily cataplexy attacks
- In the trials, 79 people were treated with WAKIX, and 75 people received placebo
At the start of the trial that measured weekly cataplexy attacks...
On average, patients had about 8 cataplexy attacks per week. Examples of cataplexy include:
At the end of the same trial...
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
Trial 3 and Trial 1 were the clinical trials for cataplexy.
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. At the start of this trial, all patients had 3 or more cataplexy attacks per week.
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.
Indications and usage & Important Safety Information
Important Safety Information
Do not take WAKIX if you are allergic to pitolisant or any ingredient in WAKIX, or if you have severe liver disease.
Tell your healthcare provider about all your medical conditions, including if you have heart rhythm irregularities, were born with a heart condition, or the levels of electrolytes in your blood are too high or too low. WAKIX has an effect on the electrical activity of the heart known as QT/QTc prolongation. Medicines with this effect can lead to disturbances in heart rhythm, which are more likely in patients with risk factors such as certain heart conditions, or when taken in combination with other medicines that affect QT. Tell your healthcare provider about all the other medicines you take.
The risk of QT prolongation may be greater in patients with liver or kidney disease. WAKIX is not recommended in patients with end-stage kidney disease.
The most common side effects seen with WAKIX were insomnia, nausea, and anxiety. Other side effects included headache, upper respiratory infection, musculoskeletal pain, heart rate increased, and decreased appetite. These are not all the possible side effects of WAKIX. Tell your healthcare provider about any side effect that bothers you or that does not go away.
Tell your healthcare provider about all the medicines you take or plan to take, including prescription and over-the-counter medicines. Some medicines can increase the amount of WAKIX that gets into your blood and some medicines can decrease the amount of WAKIX that gets into your blood. The dosage of WAKIX may need to be adjusted if you are taking these medicines.
WAKIX can also decrease the effectiveness of some medicines, including hormonal birth control methods. You should use an alternative non-hormonal birth control method during treatment with WAKIX and for at least 21 days after discontinuation of treatment.
Tell your healthcare provider if you are pregnant or planning to become pregnant. There is a pregnancy exposure registry that monitors pregnancy outcomes in women who are exposed to WAKIX during pregnancy. You are encouraged to enroll in the WAKIX pregnancy registry if you become pregnant while taking WAKIX. To enroll or obtain information from the registry, call 1-800-833-7460.
The safety and effectiveness of WAKIX have not been established in patients less than 18 years of age.
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. You can also report negative side effects to Harmony Biosciences at 1-800-833-7460.
Indications and Usage
WAKIX is a prescription medicine used to treat excessive daytime sleepiness (EDS) or sudden onset of weak or paralyzed muscles (cataplexy) in adults with narcolepsy.
Please see Full Prescribing Information.
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