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Pfizer pain drug wins approval
Ann Arbor lab develops product that treats nerve pain from diabetes and shingles.
Lyrica reduces the throbbing pain diabetics sometimes feel in their hands and feet.
Hoover
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ANN ARBOR -- Twelve years of work paid off last week for scientists at Pfizer's laboratories here when the drug giant won approval for a new drug that treats nerve pain caused by diabetes and the shingles virus.
The U.S. Food and Drug Administration approved Lyrica last week for the treatment of nerve-related pain -- a major win as Pfizer Inc. races to develop new drugs to replace revenue from older medications with expiring patents.
The drug reduces the dull throbbing pain diabetics sometimes feel in their hands and feet, explained Toni Hoover, a vice president at Pfizer's Ann Arbor labs who leads the team developing the new drug.
"Lyrica dampens the excitability of nerve endings that are highly excitable," she said. "It's sort of like putting a blanket over high-excitable nerves."
About 18 million Americans are diagnosed with diabetes, which over time can damage nerves leading to numbness or pain in the feet, legs, hands and arms. And about 150,000 Americans are diagnosed with shingles each year.
The approval comes at a tumultuous time for the Federal Drug Administration and drug companies, which have come under fire over studies suggesting that popular pain-killers such as Merck & Co.'s Vioxx and Pfizer's Celebrex could increase the risks of heart disease.
More than 9,000 patients participated in a safety test of Lyrica, Hoover said, one of the largest safety trials ever conducted for a central nervous system drug.
"It's notable that this is one of the largest submissions ever to the Food and Drug Administration," Hoover said. Applications usually include safety data from 1,000 to 3,000 patients, she said.
Lyrica is the successor to Pfizer's Neurontin, which had $2.2 billion in U.S. sales in 2003 before losing patent protection last year. Neurontin was approved to treat epilepsy and nerve pain.
The FDA still is reviewing Lyrica as a potential treatment for epilepsy.
But the new drug will face one major setback: Federal regulators have indicated they will classify it as a controlled substance, which makes it more difficult for doctors to prescribe and puts Lyrica at a disadvantage compared with Neurontin and its generic counterparts.
Despite the mixed news, Lyrica is important to Pfizer's Michigan laboratories, where scientists are working under a company quota to develop one marketable drug a year until 2005 and then two a year until 2008. That's no easy accomplishment. For every successful drug, there are 5,000 unsafe or ineffective failures. Those odds pump up research costs to about $800 million per drug.
The Ann Arbor labs first acquired Lyrica, made of the chemical compound pregabalin, from Northwestern University in 1992 and spent more than 10 years testing it on animals and humans.
The drug faced a setback when scientists found it caused tumors in mice when given at 100 times the normal dose for humans, Hoover said. But further studies proved the problem is unique to mice and the drug is safe for humans, she said.
"We didn't have the same finding in rats," Hoover said. "The FDA has found that the benefit of taking the drug outweighs any risk."
Pfizer has not yet set a date to launch Lyrica in the United States.
You can reach Sheri Hall at (313) 223-4686 or shall@detnews.com. Source: IMS Health National Prescription Audit Source: IMS Health National Prescription Audit
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