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of everyone affected by epilepsy

European commission grants licence for Lyrica (pregabalin)

27 July, 2004

The European Commission
has granted a licence for the anti-epileptic drug Lyrica to be used in
European Union member states for the treatment of peripheral
neuropathic pain and as an 'add-on' (adjunctive) therapy for partial
seizures in people with epilepsy.

Lyrica's
approval was based on the submission of ten clinical trials involving
over 9,000 people. In the clinical trials involving epilepsy patients
who continue to experience partial seizures despite treatment, adding
Lyrica to their standard treatment provided up to 51 per cent seizure
reduction in patients within the first week of treatment.

Dr Emilio Perucca, President of the Italian League Against Epilepsy and Professor at the University of Pavia, who led one of the studies, commented:

"There
is a significant need for new therapies that are well-tolerated and
help reduce seizures, especially in refractory patients. Our study
demonstrated that adding Lyrica to the treatment regimen achieves this
goal by significantly reducing the frequency of partial seizures among
patients who experienced an average of 10 seizures a month."

The
most common side effects reported by patients with either epilepsy or
neuropathic pain were dizziness and drowsiness and most side effects
were mild to moderate in intensity and generally related to the dose of
medication being taken.

Lyrica is currently under review by the US Food and Drug Administration
for the management of neuropathic pain associated with diabetic
peripheral neuropathy, as an 'add-on' therapy in the treatment of
partial seizures and for the treatment of generalised anxiety disorder
in adults.

Dr Joseph Feczko, president of Worldwide Development at Pfizer, the pharmaceutical company who manufacture Lyrica, said:

"Lyrica
is a novel compound with the potential to help a broad range of
patients. In addition to providing better seizure control for patients
with epilepsy, Lyrica is a safe and effective medicine that may improve
a variety of nerve pain that results from infection, injury, diabetes,
cancer and AIDS."