Wakix

pitolisant

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This is a summary of the European public assessment report (EPAR) for Wakix. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Wakix.

For practical information about using Wakix, patients should read the package leaflet or contact their doctor or pharmacist.

What is Wakix and what is it used for?

Wakix is a medicine used to treat adults with narcolepsy. Narcolepsy is a long-term sleep disorder which affects the brain’s ability to regulate the normal sleep-wake cycle. This leads to symptoms such as an irresistible urge to sleep, even at inappropriate times and places, and disturbed night-time sleep. Some patients also have episodes of severe muscle weakness (cataplexy) that can cause collapse. Wakix is used in patients with or without cataplexy.

Wakix contains the active substance pitolisant. Because the number of patients with narcolepsy is low, the disease is considered ‘rare’, and Wakix was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 10 July 2007.

How is Wakix used?

Wakix can only be obtained with a prescription and treatment should be started by a doctor experienced in the treatment of sleep disorders.

Wakix is available as tablets (4.5 and 18 mg). During the first week of treatment, the recommended dose is 9 mg per day, taken in the morning during breakfast. During the second week of treatment, the dose can be increased to 18 mg per day or decreased to 4.5 mg per day. During the third week, the dose may be further increased to the maximum dose of 36 mg per day. Wakix should always be used at the lowest effective dose.

In patients with moderately reduced liver function or with kidney problems, the maximum dose should be 18 mg per day.

For more information, see the package leaflet.

How does Wakix work?

The active substance in Wakix, pitolisant, works by attaching to receptors in the brain called ‘histamine H3 receptors’. This increases the activity of certain brain cells called ‘histamine neurons’, which are important for keeping the body awake.

What benefits of Wakix have been shown in studies?

Wakix has been investigated in 2 main studies involving a total of 261 adults with narcolepsy, the majority of whom also had cataplexy. The studies compared Wakix with placebo (a dummy treatment). The main measure of effectiveness was based on how sleepy patients felt during daytime, assessed using the Epworth Sleepiness Scale or ESS. This is a standard scale used in patients with narcolepsy which ranges from 0 to 24.

The first study showed that Wakix was more effective than placebo at reducing daytime sleepiness: patients taking Wakix had an average reduction of 3 points more in the ESS scale than those taking placebo after 8 weeks of treatment. Results from this study also showed a decrease in the number of cataplexy attacks. The second study, however, did not show a difference between Wakix and placebo at reducing sleepiness or cataplexy.

When looking at sleepiness with an objective test called Maintenance of Wakefulness Test or MWT, the results of the two studies together showed that Wakix significantly improved wakefulness compared with placebo.

In a further study in 105 patients with narcolepsy and cataplexy, Wakix was also more effective than placebo at reducing the number of cataplexy attacks per week: the number of cataplexy attacks decreased from around 9 to around 3 per week in patients taking Wakix, while it remained at around 7 per week in patients taking placebo.

What are the risks associated with Wakix?

The most common side effects with Wakix (which may affect up to 1 in 10 people) are insomnia (difficulty sleeping), headache, nausea (feeling sick), anxiety, irritability, dizziness, depression, tremor, sleep disorders, tiredness, vomiting, vertigo (a spinning sensation) and dyspepsia (heartburn). Serious but rare side effects are abnormal loss of weight and spontaneous abortion. For the full list of all side effects reported with Wakix, see the package leaflet.

Wakix must not be used in patients with severely reduced liver function and in women who are breastfeeding. For the full list of restrictions, see the package leaflet.

Why is Wakix approved?

The overall data available demonstrate that Wakix has a positive effect on the two major symptoms of narcolepsy, excessive daytime sleepiness and cataplexy. In addition, Wakix works differently from currently available treatments and therefore offers an alternative treatment option. The safety profile of Wakix is considered acceptable, with no major safety concerns identified.

The Agency’s Committee for Medicinal Products for Human Use (CHMP) therefore decided that Wakix’s benefits are greater than its risks and recommended that it be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Wakix?

A risk management plan has been developed to ensure that Wakix is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Wakix, including the appropriate precautions to be followed by healthcare professionals and patients.

In addition, the company that markets Wakix will carry out an observational study to collect information on the safety of the medicine when used in medical practice.

Further information can be found in the summary of the risk management plan.

Other information about Wakix

The European Commission granted a marketing authorisation valid throughout the European Union for Wakix on 31 March 2016.

For more information about treatment with Wakix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Wakix : EPAR - Summary for the public BG = bălgarski 2016-04-13  
Wakix : EPAR - Summary for the public ES = español 2016-04-13  
Wakix : EPAR - Summary for the public CS = čeština 2016-04-13  
Wakix : EPAR - Summary for the public DA = dansk 2016-04-13  
Wakix : EPAR - Summary for the public DE = Deutsch 2016-04-13  
Wakix : EPAR - Summary for the public ET = eesti keel 2016-04-13  
Wakix : EPAR - Summary for the public EL = elliniká 2016-04-13  
Wakix : EPAR - Summary for the public EN = English 2016-04-13  
Wakix : EPAR - Summary for the public FR = français 2016-04-13  
Wakix : EPAR - Summary for the public IT = italiano 2016-04-13  
Wakix : EPAR - Summary for the public LV = latviešu valoda 2016-04-13  
Wakix : EPAR - Summary for the public LT = lietuvių kalba 2016-04-13  
Wakix : EPAR - Summary for the public HU = magyar 2016-04-13  
Wakix : EPAR - Summary for the public MT = Malti 2016-04-13  
Wakix : EPAR - Summary for the public NL = Nederlands 2016-04-13  
Wakix : EPAR - Summary for the public PL = polski 2016-04-13  
Wakix : EPAR - Summary for the public PT = português 2016-04-13  
Wakix : EPAR - Summary for the public RO = română 2016-04-13  
Wakix : EPAR - Summary for the public SK = slovenčina 2016-04-13  
Wakix : EPAR - Summary for the public SL = slovenščina 2016-04-13  
Wakix : EPAR - Summary for the public FI = suomi 2016-04-13  
Wakix : EPAR - Summary for the public SV = svenska 2016-04-13  
Wakix : EPAR - Summary for the public HR = Hrvatski 2016-04-13  
Name Language First published Last updated
Wakix : EPAR - Risk-management-plan summary (English only) 2016-04-13  

This EPAR was last updated on 06/11/2017 .

Authorisation details

Product details

Product details for Wakix
NameWakix
Agency product numberEMEA/H/C/002616
Active substance

pitolisant

International non-proprietary name (INN) or common name

pitolisant

Therapeutic area Narcolepsy
Anatomical therapeutic chemical (ATC) code N07XX11
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Treatment of rare diseases

This medicine has an "orphan designation" which means that it is used to treat life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union, or are medicines which, for economic reasons, would be unlikely to be developed without incentives.

Publication details

Publication details for Wakix
Marketing-authorisation holder

Bioprojet Pharma

Revision3
Date of issue of marketing authorisation valid throughout the European Union31/03/2016

Contact address:

Bioprojet Pharma
9 rue Rameau
Paris 75002 
France

Product information

Product information

13/10/2017  Wakix -EMEA/H/C/002616 -II/0004/G

Name Language First published Last updated
Wakix : EPAR - Product Information EN = English 2016-04-13 2017-11-06
Wakix : EPAR - Product Information EN = English 2016-04-13 2017-11-06
Wakix : EPAR - Product Information EN = English 2016-04-13 2017-11-06
Wakix : EPAR - Product Information EN = English 2016-04-13 2017-11-06
Wakix : EPAR - Product Information EN = English 2016-04-13 2017-11-06
Wakix : EPAR - Product Information EN = English 2016-04-13 2017-11-06
Wakix : EPAR - Product Information EN = English 2016-04-13 2017-11-06
Wakix : EPAR - Product Information EN = English 2016-04-13 2017-11-06
Wakix : EPAR - Product Information EN = English 2016-04-13 2017-11-06
Wakix : EPAR - Product Information EN = English 2016-04-13 2017-11-06
Wakix : EPAR - Product Information EN = English 2016-04-13 2017-11-06
Wakix : EPAR - Product Information EN = English 2016-04-13 2017-11-06
Wakix : EPAR - Product Information EN = English 2016-04-13 2017-11-06
Wakix : EPAR - Product Information EN = English 2016-04-13 2017-11-06
Wakix : EPAR - Product Information EN = English 2016-04-13 2017-11-06
Wakix : EPAR - Product Information EN = English 2016-04-13 2017-11-06
Wakix : EPAR - Product Information EN = English 2016-04-13 2017-11-06
Wakix : EPAR - Product Information EN = English 2016-04-13 2017-11-06
Wakix : EPAR - Product Information EN = English 2016-04-13 2017-11-06
Wakix : EPAR - Product Information EN = English 2016-04-13 2017-11-06
Wakix : EPAR - Product Information EN = English 2016-04-13 2017-11-06
Wakix : EPAR - Product Information EN = English 2016-04-13 2017-11-06
Wakix : EPAR - Product Information EN = English 2016-04-13 2017-11-06
Wakix : EPAR - Product Information EN = English 2016-04-13 2017-11-06
Wakix : EPAR - Product Information EN = English 2016-04-13 2017-11-06

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Wakix : EPAR - All Authorised presentations EN = English 2016-04-13  
Wakix : EPAR - All Authorised presentations EN = English 2016-04-13  
Wakix : EPAR - All Authorised presentations EN = English 2016-04-13  
Wakix : EPAR - All Authorised presentations EN = English 2016-04-13  
Wakix : EPAR - All Authorised presentations EN = English 2016-04-13  
Wakix : EPAR - All Authorised presentations EN = English 2016-04-13  
Wakix : EPAR - All Authorised presentations EN = English 2016-04-13  
Wakix : EPAR - All Authorised presentations EN = English 2016-04-13  
Wakix : EPAR - All Authorised presentations EN = English 2016-04-13  
Wakix : EPAR - All Authorised presentations EN = English 2016-04-13  
Wakix : EPAR - All Authorised presentations EN = English 2016-04-13  
Wakix : EPAR - All Authorised presentations EN = English 2016-04-13  
Wakix : EPAR - All Authorised presentations EN = English 2016-04-13  
Wakix : EPAR - All Authorised presentations EN = English 2016-04-13  
Wakix : EPAR - All Authorised presentations EN = English 2016-04-13  
Wakix : EPAR - All Authorised presentations EN = English 2016-04-13  
Wakix : EPAR - All Authorised presentations EN = English 2016-04-13  
Wakix : EPAR - All Authorised presentations EN = English 2016-04-13  
Wakix : EPAR - All Authorised presentations EN = English 2016-04-13  
Wakix : EPAR - All Authorised presentations EN = English 2016-04-13  
Wakix : EPAR - All Authorised presentations EN = English 2016-04-13  
Wakix : EPAR - All Authorised presentations EN = English 2016-04-13  
Wakix : EPAR - All Authorised presentations EN = English 2016-04-13  
Wakix : EPAR - All Authorised presentations EN = English 2016-04-13  
Wakix : EPAR - All Authorised presentations EN = English 2016-04-13  

Pharmacotherapeutic group

Other nervous system drugs

Therapeutic indication

Wakix is indicated in adults for the treatment of narcolepsy with or without cataplexy.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Wakix : EPAR - Procedural steps taken and scientific information after authorisation EN = English 2016-11-30 2017-11-06

Initial marketing-authorisation documents

Name Language First published Last updated
Wakix : EPAR - Public assessment report EN = English 2016-04-13  
CHMP summary of opinion for Wakix EN = English 2015-11-20