Pfizer receives approval to market Lyrica in Europe

Published: 7-Jul-2004

Pfizer has received approval from the European Commission to market Lyrica (pregabalin) in all EU member states for the treatment of peripheral neuropathic pain and as an adjunctive therapy for partial seizures in patients with epilepsy.


Pfizer has received approval from the European Commission to market Lyrica (pregabalin) in all EU member states for the treatment of peripheral neuropathic pain and as an adjunctive therapy for partial seizures in patients with epilepsy.

Lyrica is a new compound with analgesic and anticonvulsant properties. 'Lyrica has the potential to help a broad range of patients,' said Dr Joseph Feczko, president of worldwide development at Pfizer. '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.'

Lyrica's approval was based on the submission of 10 clinical trials involving more than 9,000 patients at study sites in 10 countries. In controlled clinical trials involving patients with neuropathic pain associated with the shingles and diabetic neuropathy, significant pain relief was seen as early as week one and lasted throughout the studies. Also, on average, up to 47% of patients treated with Lyrica experienced a 50% reduction in pain, as measured by a standard rating scale. Lyrica-treated patients also experienced a significant reduction in pain-related sleep interference across clinical studies.

In clinical trials involving epilepsy patients who continue to experience partial seizures despite treatment, adding Lyrica to their standard treatment provided up to 51% seizure reduction in patients within the first week of treatment. Lyrica was also well tolerated.

Lyrica is currently under review by the US FDA for the management of neuropathic pain associated with diabetic peripheral neuropathy and herpes zoster (postherpetic neuralgia), as adjunctive therapy in the treatment of partial seizures, and for the treatment of generalised anxiety disorder in adults.

  

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