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Duloxetine Approved to Treat Diabetic Pain
Duloxetine Approved to Treat Diabetic Pain -- Posted by Gumbo on 10-31-04 05:12
Duloxetine Approved to Treat Diabetic Pain
NEW YORK (Reuters) Sept 07 - Eli Lilly and Co. said on Tuesday that U.S.
regulators have approved its new antidepressant Cymbalta (duloxetine) as a
treatment for pain associated with diabetic neuropathy, making it the first
drug to be approved for the disorder.
The U.S. Food and Drug Administration said the company can market the drug
to treat diabetic peripheral neuropathic pain, which affects up to 5 million
Americans. Last month the FDA approved Cymbalta as a treatment for major
depression.
The approval is based on the results of two 12-week trials -- each trial
tested a different dosage -- in non-depressed adults. On average, patients
in the studies were 60 years old, had had diabetes for 11 years and related
neuropathic pain for 4 years.
The company said Cymbalta significantly reduced 24-hour average pain levels
compared with a placebo. While the drug does nothing to treat the nerve
damage that causes the pain, it reduces the symptoms r.
Cymbalta is a serotonin and norepinephrine reuptake inhibitor. Many
researchers believe that it is the raised level of norepinephrine that is
mainly responsible for the effect on pain.
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