F.D.A. Approves Pfizer Remedy for Nerve Pain From Diabetes

Published: January 1, 2005

Pfizer Inc. said yesterday that it had won United States approval to sell its Lyrica pill to treat nerve pain associated with diabetes and shingles.

The Food and Drug Administration is still reviewing Lyrica as a potential treatment for seizures in adults, Pfizer said in a statement.

In September, the F.D.A. delayed action on Lyrica until Pfizer provided more data.

Henry A. McKinnell Jr., the chief executive of Pfizer, which is battling a sliding stock price and fallout from a study linking the company's Celebrex painkiller to heart attacks, is counting on new drugs like Lyrica to increase sales as some of the company's biggest products face competition.

Lyrica is the successor to a Pfizer epilepsy drug, Neurontin, which had $2.2 billion in United States sales in 2003 before generic competitors entered the market this year.

"Having the product available for most of 2005 is a big positive for the company," said Trevor Polischuk, a pharmaceuticals analyst at Orbimed Advisors in New York, which manages investments, including Pfizer shares. Pain is the most important indication for Lyrica, with epilepsy being "a very small opportunity," Mr. Polischuk said.

Shares of Pfizer slipped 12 cents, to $26.89, in New York Stock Exchange composite trading.

Diabetes can damage nerves over time, leading to numbness or pain in hands, arms, feet and legs, according to the National Institutes of Health. Almost half of the 18 million Americans with diabetes will develop some form of nerve pain, Pfizer said in a statement.

Worldwide sales of Lyrica as a treatment for pain and seizures may reach $2.9 billion by 2008, said Sena Lund, an analyst with Cathay Financial in New York, who has a neutral rating on Pfizer and owns the stock. He did not have a sales estimate for Lyrica as a pain treatment only, although he said more than 70 percent of Neurontin's sales come from uses other than epilepsy.

"The important thing is they got approval," Mr. Lund said.

Pfizer has not set a date for Lyrica's introduction in the United States or a price for the drug, a spokeswoman, Mariann Caprino, said in an e-mail message. The company won European approval in July to sell Lyrica for epilepsy and nerve pain.

Lyrica will compete with Eli Lilly & Company's Cymbalta antidepressant, which the F.D.A. cleared in September as a treatment for peripheral neuropathic pain. Cymbalta was the first drug in the United States specifically approved for that use.