MONDAY, June 16 (HealthDay News) -- Eli Lilly said Monday that
its antidepressant Cymbalta (duloxetine) has been approved by the
U.S. Food and Drug Administration to treat fibromyalgia, a chronic
disorder with symptoms including widespread muscle pain and
tenderness.
The condition affects about 2 percent of the American
population, or about 5 million people, mostly women. While its
cause is unknown and there is no known cure, it's believed it may
be related to a combination of changes in brain and spinal cord
chemistry, genetic factors, and stress, the company said in a
statement.
Cymbalta affects production of two naturally occurring brain
substances, serotonin and norepinephrine. In addition to affecting
mood, it's believed these substances are part of the body's natural
pain-surpressing system, Lilly said.
In a pair of three-month trials involving 874 people with
fibromyalgia, Cymbalta significantly reduced pain levels, compared
with a non-medicinal placebo, the company said. Common adverse
reactions included nausea, dry mouth, constipation, decreased
appetite, and sleepiness.
Cymbalta also is approved to treat major depressive disorder and
generalized anxiety disorder, and a form of nerve pain in
diabetics, all in adults 18 and older.
More information
To learn more about this drug, visit the FDA's
Center for Drug Evaluation and Research.
