FDA Approves Pfizer Drug for Diabetes
Posted on: Sunday, 2 January 2005, 00:00 CST
NEW YORK - Pfizer Inc. said Friday the U.S. Food and Drug Administration has approved its medication for pain caused by nerve damage from diabetes or shingles, but it is still under review for treating partial seizures in adults.
Pfizer said that Lyrica is the first FDA-approved treatment for this pain, often described as burning, tingling, sharp, stabbing or pins and needles in the feet, legs, hands or arms.
The drug has not yet been approved for treating partial seizures in adults; the company said that use is still under review by the FDA.
It said the types of pain that Lyrica treats are different from arthritis or musculoskeletal pain.
Pfizer shares closed down 12 cents, to $26.89, on the New York Stock Exchange Friday.
The company estimates that about 3 million diabetes sufferers in America will develop painful nerve damage over the course of the disease while roughly 150,000 Americans develop nerve damage because of shingles each year.
"Lyrica is an important new therapy for millions of people suffering from the two most common neuropathic pain conditions as it provides rapid and sustained pain relief," said Dr. Joseph Feczko, president of Worldwide Development at Pfizer, in a statement.
The company said that the drug's safety has been established through clinical trials involving about 9,000 patients and the most common side effects were dizziness, drowsiness, dry mouth, an abnormal build up of fluids in the ankle and legs, blurred vision, weight gain and difficulty with concentration.
Lyrica will be available for doctors to prescribe in the near future, Pfizer said.
Source: Associated Press/AP Online
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