Lyrica, Pfizer's successor to its blockbuster CNS drug Neurontin has been launched in the UK as a treatment for peripheral neuropathic pain or NeP.

Pfizer will market the drug primarily as a treatment for neuropathic pain rather than for its other indication as an adjunctive therapy in epilepsy, promoting the drug's novel mechanism as an effective treatment for an unmet clinical need.

A recent Pfizer-sponsored UK study of over 600 NeP patients showed 74% of people of working age are unable to work, and almost two out of three require a walking aid to remain mobile.

The study also revealed that 63% of patients have never received a definitive diagnosis to explain why they have NeP. More than two-thirds of the patients in the study felt that their condition was not under satisfactory review leading to a feeling of being forgotten among many patients.

The company says the condition affects nearly 2.5% of the total population and 8% in older age groups, and is one of the hardest pain syndromes to treat. Patients with cancer, diabetes and shingles are particularly susceptible, with one-third of cancer patients suffering and one in four diabetes patients suffering from the condition.

Neuropathic pain is generally managed with tricyclic antidepressants and some anti-epileptic drugs or opiods when other treatments fail to relieve the pain, but Pfizer's research shows patients continue to suffer.

Dr Martin Johnson, a GP with a special interest in pain from Ashville Medical Centre in Barnsley, said: "Older treatments available for NeP can be ineffective, difficult to use or have side-effects leaving patients with unbearable pain that dominates their lives. Moreover, some treatments are not even licensed. Lyrica represents new hope for many of the patients I see every day, including people with diabetes and shingles, offering them the chance to regain control of their lives."

Lyrica (pregabalin) has anticonvulsant as well as analgesic properties and also has a UK licence as a therapy for adults with epilepsy who have partial seizures with or without secondary generalisation.

Pfizer says its new drug can help relieve the burden of pain in up to half of neuropathic pain patients, reducing symptoms by 50% or more and says common side-effects such as dizziness and drowsiness were mild to moderate and generally dose-related.

Lyrica works by restoring the activity of overactive nerves involved in pain and epilepsy to more normal levels and it will be available in both primary and secondary care settings.

The drug arrives on the UK market ahead of the National Service Framework for long-term conditions, which is expected in December and will include guidelines on the treatment of neuropathic pain

The drug is a follow-up to Pfizer's older Neurontin, which made peak sales of $2.7 billion in 2003, a figure Lyrica is tipped to eventually match. Off-label prescribing of Neurontin, has been a major factor in its success and Lyrica's versatility means it is likely to enjoy similar unlicensed use by doctors.

In the UK GlaxoSmithKline's Lamictal is the market leader in the anticonvulsant class, maintaining its lead with a 9% rise in sales in England in 2003 to £50.1 million. Pfizer's second-placed Neurontin closed the gap with a 28% rise in sales to £44 million last year but is off-patent in the UK.

Barbara Hoggart, a consultant in pain management at the Birmingham Heartlands and Solihull NHS Trust welcomed the launch, saying: 'Lyrica is not just effective but has a simple dosing structure that makes it easy to use. This means primary care teams can initiate early treatment for appropriate cases. It is important to develop clearer guidance in the management of NeP to facilitate this process."

Pfizer is still awaiting a definite approval in the US, where the company has received approvable letters from the FDA for three of the four indications it is seeking, but details of the regulators' demands have not been disclosed.

The FDA gave conditional approval to indications for the drug for: neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, and as an adjunctive therapy in the treatment of partial seizures in adults. But as a treatment for generalised anxiety disorder Pfizer received a non-approvable letter.

The company said it is continuing to work closely with the FDA during the regulatory review to resolve issues on all indications and the product's labelling.

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Pfizer's next blockbuster Lyrica receives European approval 

Thursday , July 08, 2004

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