Lyrica

pregabalin

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This is a summary of the European public assessment report (EPAR) for Lyrica. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Lyrica.

What is Lyrica?

Lyrica is a medicine that contains the active substance pregabalin. It is available as capsules (white: 25, 50 and 150 mg; white and orange: 75, 225 and 300 mg; orange: 100 mg; light orange: 200 mg) and as an oral solution (20 mg/ml).

What is Lyrica used for?

Lyrica is used to treat adults with the following conditions:

  • neuropathic pain (pain due to nerve damage). Lyrica can be used in peripheral neuropathic pain, such as the pain experienced by diabetic patients or by patients who have had herpes zoster (shingles), and central neuropathic pain, such as the pain experienced by patients who have had a spinal-cord injury;
  • epilepsy. Lyrica is used as an ‘add-on’ to existing treatment in patients who have partial seizures (epileptic fits starting in one specific part of the brain) that cannot be controlled with their current treatment;
  • generalised anxiety disorder (long-term anxiety or nervousness about everyday matters).

The medicine can only be obtained with a prescription.

How is Lyrica used?

The recommended starting dose of Lyrica is 150 mg per day, divided into two or three doses. After three to seven days, the dose can be increased to 300 mg per day. Doses can be increased up to twice more until the most effective dose is reached. The maximum dose is 600 mg per day. Stopping treatment with Lyrica should also be done gradually, over at least a week.

The capsules should be swallowed whole with water. Patients who have kidney problems need to take lower doses.

How does Lyrica work?

The active substance in Lyrica, pregabalin, is similar in structure to the body’s own ‘neurotransmitter’ gamma-amino butyric acid (GABA), but has very different biological effects. Neurotransmitters are chemicals that allow nerve cells to communicate with each other. The exact way that pregabalin works is not fully understood, but it is thought to affect the way that calcium enters nerve cells. This reduces the activity of some of the nerve cells in the brain and spinal cord, reducing the release of other neurotransmitters that are involved in pain, epilepsy and anxiety.

How has Lyrica been studied?

Lyrica has been compared with placebo (a dummy treatment) in 22 studies:

  • for peripheral neuropathic pain, there were ten studies involving over 3,000 patients, about half of whom had diabetic neuropathy and half of whom had pain following shingles. A further study was carried out in 137 patients with central neuropathic pain due to a spinal-cord injury. The studies lasted up to 12 weeks. The effectiveness of Lyrica was measured using a standard pain questionnaire;
  • for epilepsy, there were three studies involving over 1,000 patients. The main measure of effectiveness was the change in the number of seizures after 11 to 12 weeks;
  • for generalised anxiety disorder, there were eight studies involving over 3,000 patients. Effectiveness was measured using a standard anxiety questionnaire after four to eight weeks.
What benefit has Lyrica shown during the studies?

In neuropathic pain, Lyrica was more effective than placebo in decreasing pain. In peripheral neuropathic pain, 35% of the patients treated with Lyrica had a decrease in pain scores of 50% or more, compared with 18% of the patients treated with placebo. In central neuropathic pain, 22% of patients treated with Lyrica had a decrease in pain scores of 50% or more, compared with 8% of the patients treated with placebo.

In epilepsy, Lyrica reduced the number of seizures: about 45% of the patients taking 600 mg Lyrica a day and about 35% of those taking 300 mg Lyrica a day had a reduction in seizures of 50% or more. This compared with about 10% of the patients taking placebo.

In generalised anxiety disorder, Lyrica was more effective than placebo: 52% of the patients taking Lyrica had an improvement of 50% or more, compared with 38% of the patients taking placebo.

What is the risk associated with Lyrica?

The most common side effects with Lyrica (seen in more than 1 patient in 10) are dizziness and somnolence (sleepiness). For the full list of all side effects reported with Lyrica, see the package leaflet.

Lyrica should not be used in people who may be hypersensitive (allergic) to pregabalin or any of the other ingredients.

Why has Lyrica been approved?

The CHMP decided that Lyrica’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Lyrica

The European Commission granted a marketing authorisation valid throughout the European Union for Lyrica to Pfizer Limited on 6 July 2004. The marketing authorisation is valid for an unlimited period.

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

Name Language First published Last updated
Lyrica : EPAR - Summary for the public BG = bălgarski 18/08/2009 18/06/2010
Lyrica : EPAR - Summary for the public ES = español 18/08/2009 18/06/2010
Lyrica : EPAR - Summary for the public CS = čeština 18/08/2009 18/06/2010
Lyrica : EPAR - Summary for the public DA = dansk 18/08/2009 18/06/2010
Lyrica : EPAR - Summary for the public DE = Deutsch 18/08/2009 18/06/2010
Lyrica : EPAR - Summary for the public ET = eesti keel 18/08/2009 18/06/2010
Lyrica : EPAR - Summary for the public EL = elliniká 18/08/2009 18/06/2010
Lyrica : EPAR - Summary for the public EN = English 18/08/2009 18/06/2010
Lyrica : EPAR - Summary for the public FR = français 18/08/2009 18/06/2010
Lyrica : EPAR - Summary for the public IT = italiano 18/08/2009 18/06/2010
Lyrica : EPAR - Summary for the public LV = latviešu valoda 18/08/2009 18/06/2010
Lyrica : EPAR - Summary for the public LT = lietuvių kalba 18/08/2009 18/06/2010
Lyrica : EPAR - Summary for the public HU = magyar 18/08/2009 18/06/2010
Lyrica : EPAR - Summary for the public MT = Malti 18/08/2009 18/06/2010
Lyrica : EPAR - Summary for the public NL = Nederlands 18/08/2009 18/06/2010
Lyrica : EPAR - Summary for the public PL = polski 18/08/2009 18/06/2010
Lyrica : EPAR - Summary for the public PT = português 18/08/2009 18/06/2010
Lyrica : EPAR - Summary for the public RO = română 18/08/2009 18/06/2010
Lyrica : EPAR - Summary for the public SK = slovenčina 18/08/2009 18/06/2010
Lyrica : EPAR - Summary for the public SL = slovenščina 18/08/2009 18/06/2010
Lyrica : EPAR - Summary for the public FI = suomi 18/08/2009 18/06/2010
Lyrica : EPAR - Summary for the public SV = svenska 18/08/2009 18/06/2010

This EPAR was last updated on 15/03/2016 .

Authorisation details

Product details

Product details for Lyrica
NameLyrica
Agency product numberEMEA/H/C/000546
Active substance

pregabalin

International non-proprietary name (INN) or common name

pregabalin

Therapeutic area EpilepsyAnxiety DisordersNeuralgia
Anatomical therapeutic chemical (ATC) code N03AX16

Publication details

Publication details for Lyrica
Marketing-authorisation holder

Pfizer Limited

Revision33
Date of issue of marketing authorisation valid throughout the European Union06/07/2004

Contact address:

Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

Product information

Product information

23/11/2015  Lyrica -EMEA/H/C/000546 -N/0080

Name Language First published Last updated
Lyrica : EPAR - Product Information SV = svenska 23/09/2009 25/01/2016
Lyrica : EPAR - Product Information SV = svenska 23/09/2009 25/01/2016
Lyrica : EPAR - Product Information SV = svenska 23/09/2009 25/01/2016
Lyrica : EPAR - Product Information SV = svenska 23/09/2009 25/01/2016
Lyrica : EPAR - Product Information SV = svenska 23/09/2009 25/01/2016
Lyrica : EPAR - Product Information SV = svenska 23/09/2009 25/01/2016
Lyrica : EPAR - Product Information SV = svenska 23/09/2009 25/01/2016
Lyrica : EPAR - Product Information SV = svenska 23/09/2009 25/01/2016
Lyrica : EPAR - Product Information SV = svenska 23/09/2009 25/01/2016
Lyrica : EPAR - Product Information SV = svenska 23/09/2009 25/01/2016
Lyrica : EPAR - Product Information SV = svenska 23/09/2009 25/01/2016
Lyrica : EPAR - Product Information SV = svenska 23/09/2009 25/01/2016
Lyrica : EPAR - Product Information SV = svenska 23/09/2009 25/01/2016
Lyrica : EPAR - Product Information SV = svenska 23/09/2009 25/01/2016
Lyrica : EPAR - Product Information SV = svenska 23/09/2009 25/01/2016
Lyrica : EPAR - Product Information SV = svenska 23/09/2009 25/01/2016
Lyrica : EPAR - Product Information SV = svenska 23/09/2009 25/01/2016
Lyrica : EPAR - Product Information SV = svenska 23/09/2009 25/01/2016
Lyrica : EPAR - Product Information SV = svenska 23/09/2009 25/01/2016
Lyrica : EPAR - Product Information SV = svenska 23/09/2009 25/01/2016
Lyrica : EPAR - Product Information SV = svenska 23/09/2009 25/01/2016
Lyrica : EPAR - Product Information SV = svenska 23/09/2009 25/01/2016
Lyrica : EPAR - Product Information SV = svenska 23/09/2009 25/01/2016
Lyrica : EPAR - Product Information SV = svenska 23/09/2009 25/01/2016
Lyrica : EPAR - Product Information SV = svenska 23/09/2009 25/01/2016

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
Lyrica : EPAR - All Authorised presentations SV = svenska 23/08/2007 06/10/2014
Lyrica : EPAR - All Authorised presentations SV = svenska 23/08/2007 06/10/2014
Lyrica : EPAR - All Authorised presentations SV = svenska 23/08/2007 06/10/2014
Lyrica : EPAR - All Authorised presentations SV = svenska 23/08/2007 06/10/2014
Lyrica : EPAR - All Authorised presentations SV = svenska 23/08/2007 06/10/2014
Lyrica : EPAR - All Authorised presentations SV = svenska 23/08/2007 06/10/2014
Lyrica : EPAR - All Authorised presentations SV = svenska 23/08/2007 06/10/2014
Lyrica : EPAR - All Authorised presentations SV = svenska 23/08/2007 06/10/2014
Lyrica : EPAR - All Authorised presentations SV = svenska 23/08/2007 06/10/2014
Lyrica : EPAR - All Authorised presentations SV = svenska 23/08/2007 06/10/2014
Lyrica : EPAR - All Authorised presentations SV = svenska 23/08/2007 06/10/2014
Lyrica : EPAR - All Authorised presentations SV = svenska 23/08/2007 06/10/2014
Lyrica : EPAR - All Authorised presentations SV = svenska 23/08/2007 06/10/2014
Lyrica : EPAR - All Authorised presentations SV = svenska 23/08/2007 06/10/2014
Lyrica : EPAR - All Authorised presentations SV = svenska 23/08/2007 06/10/2014
Lyrica : EPAR - All Authorised presentations SV = svenska 23/08/2007 06/10/2014
Lyrica : EPAR - All Authorised presentations SV = svenska 23/08/2007 06/10/2014
Lyrica : EPAR - All Authorised presentations SV = svenska 23/08/2007 06/10/2014
Lyrica : EPAR - All Authorised presentations SV = svenska 23/08/2007 06/10/2014
Lyrica : EPAR - All Authorised presentations SV = svenska 23/08/2007 06/10/2014
Lyrica : EPAR - All Authorised presentations SV = svenska 23/08/2007 06/10/2014
Lyrica : EPAR - All Authorised presentations SV = svenska 23/08/2007 06/10/2014
Lyrica : EPAR - All Authorised presentations SV = svenska 23/08/2007 06/10/2014
Lyrica : EPAR - All Authorised presentations SV = svenska 23/08/2007 06/10/2014
Lyrica : EPAR - All Authorised presentations SV = svenska 23/08/2007 06/10/2014

Pharmacotherapeutic group

Anti-epileptics, other anti-epileptics

Therapeutic indication

Neuropathic pain

  • Lyrica is indicated for the treatment of peripheral and central neuropathic pain in adults.

Epilepsy

  • Lyrica is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.

Generalised anxiety disorder

  • Lyrica is indicated for the treatment of generalised anxiety disorder (GAD) in adults.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Lyrica : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 23/09/2009 25/01/2016
Lyrica-H-C-546-P46-051 : EPAR - Assessment Report SV = svenska 15/03/2016  
Lyrica-H-C-546-P46-0048 : EPAR - Assessment Report SV = svenska 10/11/2015  
Lyrica-H-C-546-P46-0045 : EPAR - Assessment Report SV = svenska 17/11/2014  
Lyrica-H-C-546-P45-0024 : EPAR - Assessment Report SV = svenska 04/02/2013  
Lyrica-H-C-546-II-0024 : EPAR - Refusal assessment report - Variation SV = svenska 11/08/2009  
Questions and answers on recommendation for the refusal of a change to the marketing authorisation for Lyrica SV = svenska 24/07/2009  
Questions and answers on recommendation for the refusal of a change to the marketing authorisation for Lyrica SV = svenska 24/07/2009  
Questions and answers on recommendation for the refusal of a change to the marketing authorisation for Lyrica SV = svenska 24/07/2009  
Questions and answers on recommendation for the refusal of a change to the marketing authorisation for Lyrica SV = svenska 24/07/2009  
Questions and answers on recommendation for the refusal of a change to the marketing authorisation for Lyrica SV = svenska 24/07/2009  
Questions and answers on recommendation for the refusal of a change to the marketing authorisation for Lyrica SV = svenska 24/07/2009  
Questions and answers on recommendation for the refusal of a change to the marketing authorisation for Lyrica SV = svenska 24/07/2009  
Questions and answers on recommendation for the refusal of a change to the marketing authorisation for Lyrica SV = svenska 24/07/2009  
Questions and answers on recommendation for the refusal of a change to the marketing authorisation for Lyrica SV = svenska 24/07/2009  
Questions and answers on recommendation for the refusal of a change to the marketing authorisation for Lyrica SV = svenska 24/07/2009  
Questions and answers on recommendation for the refusal of a change to the marketing authorisation for Lyrica SV = svenska 24/07/2009  
Questions and answers on recommendation for the refusal of a change to the marketing authorisation for Lyrica SV = svenska 24/07/2009  
Questions and answers on recommendation for the refusal of a change to the marketing authorisation for Lyrica SV = svenska 24/07/2009  
Questions and answers on recommendation for the refusal of a change to the marketing authorisation for Lyrica SV = svenska 24/07/2009  
Questions and answers on recommendation for the refusal of a change to the marketing authorisation for Lyrica SV = svenska 24/07/2009  
Questions and answers on recommendation for the refusal of a change to the marketing authorisation for Lyrica SV = svenska 24/07/2009  
Questions and answers on recommendation for the refusal of a change to the marketing authorisation for Lyrica SV = svenska 24/07/2009  
Questions and answers on recommendation for the refusal of a change to the marketing authorisation for Lyrica SV = svenska 24/07/2009  
Questions and answers on recommendation for the refusal of a change to the marketing authorisation for Lyrica SV = svenska 24/07/2009  
Questions and answers on recommendation for the refusal of a change to the marketing authorisation for Lyrica SV = svenska 24/07/2009  
Questions and answers on recommendation for the refusal of a change to the marketing authorisation for Lyrica SV = svenska 24/07/2009  
Questions and answers on recommendation for the refusal of a change to the marketing authorisation for Lyrica SV = svenska 24/07/2009  
Lyrica-H-C-546-II-0007 : EPAR - Scientific Discussion - Variation SV = svenska 18/01/2007  
Lyrica-H-C-546-II-0004 : EPAR - Scientific Discussion - Variation SV = svenska 13/09/2006  

Initial marketing-authorisation documents

Name Language First published Last updated
Lyrica : EPAR - Procedural steps taken before authorisation SV = svenska 21/10/2005  
Lyrica : EPAR - Scientific Discussion SV = svenska 21/10/2005  

Authorised

This medicine is approved for use in the European Union