What is Lyrica?
Lyrica is a medicine that contains the active substance pregabalin. It is available as capsules (white in color: 25 mg, 50 mg and 150 mg; white and orange: 75 mg, 225 mg and 300 mg; orange: 100 mg; light orange: 200 mg).
What is Lyrica used for?
Lyrica is used to treat adults with the following conditions:
- neuropathic pain (pain caused by damage to the nervous system). Lyrica can be used to treat peripheral neuropathic pain, for example in patients with diabetes or shingles (shingles), and central neuropathic pain, which affects, for example, patients who have suffered a spinal cord injury;
- epilepsy. Lyrica is given as adjunctive therapy to ongoing therapy in patients with partial seizures (seizures that begin in a specific area of the brain) that cannot be controlled with ongoing therapy;
- generalized anxiety disorder (chronic anxiety or nervousness in everyday life)
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 a day. Doses can be increased up to twice the dosage until the most effective dose is reached. The maximum daily dose is 600 mg a day. Also the suspension of the treatment with Lyrica must take place gradually, over at least a week.
The capsules should be swallowed whole, with water, with or without food. In patients with kidney problems the dosage is lower.
How does Lyrica work?
The active ingredient of Lyrica, pregabalin, is similar in structure to the "neurotransmitter" of the organism gamma-amino butyric acid (GABA), but has very different biological effects. Neurotransmitters are chemicals that allow nerve cells to communicate with each other. The precise mode of action of pregabalin is not entirely known, but pregabalin is believed to affect the way calcium penetrates nerve cells. This reduces the activity of some nerve cells in the brain and spinal cord, with a consequent reduction in the release of other neurotransmitters that intervene in pain, epilepsy and anxiety.
What studies have been carried out on Lyrica?
Lyrica was compared with placebo (a dummy treatment) in 22 studies:
- for neuropathic pain, ten studies were performed, involving more than 3, 000 patients with peripheral neuropathic pain. About half of the patients had diabetic neuropathy, the other half had a shingle pain. Another study was carried out on 137 patients with central neuropathic pain due to spinal cord injury. The studies lasted up to 12 weeks and the efficacy of Lyrica was measured based on a standard pain questionnaire;
- for epilepsy, three studies were conducted on a total of over 1 000 patients. The change in the number of seizures after a period of 11-12 weeks was the main measure of effectiveness;
- Eight studies have been carried out for generalized anxiety disorder, involving over 3, 000 patients. Efficacy was measured based on a standard anxiety questionnaire after four to eight weeks.
What benefit has Lyrica shown during the studies?
In studies of neuropathic pain, Lyrica was more effective than placebo in reducing pain. In studies on peripheral neuropathic pain, 35% of patients treated with Lyrica had a 50% or more decrease in their pain score compared to 18% of placebo-treated patients. In studies of central neuropathic pain, 22% of patients treated with Lyrica had a 50% or more decrease in their pain score compared to 8% in patients treated with placebo.
In epilepsy studies, Lyrica reduced the number of seizures: about 45% of patients taking Lyrica 600 mg had a 50% or more reduction in seizures and about 35% in subjects receiving 300 mg day, compared to approximately 10% of patients treated with placebo.
In studies on generalized anxiety disorder Lyrica was more effective than placebo: 52% of patients taking Lyrica had improved by 50% or more compared to 38% of patients treated with placebo.
What are the risks associated with Lyrica?
The most common side effects seen with Lyrica (seen in more than 1 patient in 10) are dizziness and drowsiness. 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 substances.
Why has Lyrica been approved?
The Committee for Medicinal Products for Human Use (CHMP) has determined that the benefits of Lyrica are greater than its risks in the treatment of peripheral and central neuropathic pain in adults, as adjunctive therapy in adults with partial seizures with or without secondary generalization and treatment of generalized anxiety disorder in adults. The Committee recommended that Lyrica be given marketing authorization.
Other information on Lyrica:
On 6 July 2004, the European Commission granted a marketing authorization valid for Lyrica, valid throughout the European Union, to Pfizer Limited. The marketing authorization was renewed on 6 July 2009.
For the full EPAR for Lyrica, click here.
Last update of this summary: 07-2009.
