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Pfizer's next blockbuster Lyrica receives European approval

Published on 08/07/04 at 05:02pm

Pfizer's potential central nervous system blockbuster Lyrica (pregabalin) has received European marketing approval.

The drug has received licences for the treatment of neuropathic pain and as an adjunctive treatment for partial seizures in patients with epilepsy.

Neuropathic (nerve) pain, caused by medical conditions including diabetes, epilepsy, infection (herpes zoster), cancer and AIDS, affects about 3% of Europeans and is one of the most difficult chronic pain syndromes to treat.

"Lyrica is a novel compound with the potential to help a broad range of patients," said Dr Joseph Feczko, president of worldwide development for 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, cancer and AIDS."

The 9,000-patient clinical trials across 10 countries showed that up to 47% of patients treated with Lyrica experienced a 50% reduction in neuropathic pain; adding Lyrica to the standard treatment of epilepsy patients, who continued to experience partial seizures, provided up to 51% seizure reductions within the first week of treatment.

Despite the availability of treatments, more than 30% of the six million epilepsy sufferers in Europe continue to have seizures, which indicates a significant market opportunity for Lyrica as an adjunctive treatment.

"There is a significant need for new therapies that are well-tolerated and help reduce seizures, especially in refractory patients," said Dr Emilio Perucca, president of the Italian League Against Epilepsy and professor at Pavia University, Italy.

"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," he said.

The drug is a follow-up to Pfizer's older CNS drug Neurontin which achieved peak sales of $2.7 billion in 2003, a figure analysts expect Lyrica to go on to match. Off-label prescribing of Neurontin was a major factor in its success and Lyrica's versatility means it is likely to enjoy similar unlicensed use by doctors.

The drug has not yet been approved in the US, where the FDA is currently reviewing Lyrica for a remarkable four separate indications at once: neuropathic pain associated with diabetic peripheral neuropathy; herpes zoster (post herpetic neuralgia); as adjunctive therapy in the treatment of seizures and for the treatment of generalised anxiety disorder in adults.

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