Pfizer Drug Wins FDA Approval To Treat Nerve Pain, Not Epilepsy
Happy New Year, if not for PFE ;-) Doc
By SCOTT HENSLEY
Staff Reporter of THE WALL STREET JOURNAL
December 31, 2004 10:46 a.m.
Pfizer Inc. was dealt an unexpected blow as federal regulators indicated they would classify Lyrica, a drug to treat persistent nerve pain, as a controlled substance, even as the Food and Drug Administration finally approved it for sale.
In another disappointment for Pfizer, the FDA didn't approve Lyrica as an aid to managing convulsions from epilepsy, as had been expected. Lyrica was cleared to treat pain from nerves damaged by diabetes and by shingles, a viral infection.
The mixed decision is a major setback for the New York-based drug maker that has been counting on strong sales of Lyrica to offset declines in Neurontin, a similar Pfizer medicine that became a generic drug earlier this year.
As a medicine subject to the controlled-substance rules of the Drug Enforcement Administration, Lyrica would present administrative hassles for doctors and pharmacists. These strictures would put Lyrica at a significant disadvantage to generic Neurontin. The medicine is approved to treat epilepsy and nerve pain after shingles. Neurontin isn't approved for painful nerves damaged by diabetes, but doctors frequently prescribe the medicine for that purpose.
"As a controlled substance, Lyrica is harder to advertise, prescribe, stock and dispense than generic gabapentin, all for no apparent therapeutic benefit," said Richard Evans, pharmaceuticals analyst at Sanford C. Bernstein in New York. "This puts Pfizer in an extremely weak selling position versus their own generic."
A Pfizer spokeswoman said the launch date and price for Lyrica couldn't be determined until the DEA completes its review. That process could take weeks or months.
Lyrica, known generically as pregabalin, is the long-anticipated successor to Neurontin, Pfizer's fourth-biggest seller last year.
In 2003, Neurontin sales were $2.70 billion. Amid protracted patent battles, Alpharma Inc. and Teva Pharmaceuticals Industries Ltd. launched a generic form of Neurontin in October. Greenstone Limited, a Pfizer subsidiary, countered with its own generic. Another generic was launched by Ivax Corp. during the summer, but that form of the drug has subtle chemical differences that mean it can't be automatically substituted by a pharmacist for Neurontin.
The copycats got quick traction. Generic gabapentin sales in the U.S. were $123 million in October and November, according to data from NDCHealth, Atlanta, compared with Neurontin sales of $325 million.
Lyrica has been delayed for several years. Early on, FDA asked Pfizer to perform more studies on the drug's safety, after some mice taking the drug in early tests developed tumors. Subsequent studies in rats and monkeys found no tumor problems. Three years ago, Pfizer said it would postpone applying for FDA approval until it completed clinical studies to support multiple uses of Lyrica. The company finally submitted its application in 2003 for three indications: epilepsy, anxiety and pain.
In September, the FDA rejected Lyrica as a treatment for generalized anxiety disorder. Pfizer said it hasn't given up on that use. If approved to treat anxiety, Lyrica would be an alternative to antidepressants and older anxiety drugs called benzodiazapenes, such as Valium.
Pfizer said clinical studies of Lyrica involved more than 9,000 patients, making the project one of the largest for a drug active in the central nervous system. The most common side effects were dizziness, sleepiness, swelling from retained fluid, or edema, dry mouth and weight gain.
European regulators approved Lyrica in July to treat nerve pain and as an adjunct to other drugs in managing epilepsy.
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