Pfizer said yesterday its Lyrica product had been approved by the European Medicines Agency to treat central neuropathic pain, such as that which occurs in spinal cord injury, stroke and multiple sclerosis.
Lyrica (pregabalin) is already cleared in Europe for peripheral forms of neuropathic pain, such as that caused by diabetes or shingles, as well the adjunctive treatment of partial epilepsy and generalised anxiety disorder.
But the new approval is significant for patients as there are limited treatment options for central neuropathic pain, which often requires the use of high-dose opioid analgesics. It will add further momentum to a product that is currently Pfizer’s fastest-growing top 10 product, with global first-half 2006 sales advancing 58% to $463 million.
Lyrica is the only medication approved in the EU to treat both peripheral and central neuropathic pain, which affects up to 7.7 million people in Europe, said Pfizer in a statement.
The European approval is based on a clinical trial in 137 patients with pain resulting from damage to their spinal cords, in which Lyrica achieved a significant reduction in the average intensity of pain compared to placebo. More than 40% of patients had greater than a 30% reduction in pain with Lyrica, compared to 16% of patients on placebo.
- Meanwhile, Pfizer has forged a $155 million agreement with TransTech Pharma to secure rights to a series of RAGE (receptor for advanced glycation end products) modulators – compounds with potential in the treatment of Alzheimer’s disease and diabetic neuropathy. The deal gives Pfizer rights to TTP488, an orally-active small-molecule drug in Phase II for both these indications, as well as a large-molecule compound that is due to start clinical trials before the end of the year.