INDIANAPOLIS, Nov. 4, 2010 /PRNewswire-FirstCall/ — Eli Lilly
and Company (NYSE:
LLY) announced that the U.S. Food and Drug Administration (FDA)
has approved Cymbalta® (duloxetine HCl) for the management of
chronic musculoskeletal pain. This has been established in studies
in patients with chronic low back pain and chronic pain due to
osteoarthritis. This is the fifth indication the FDA has approved
for Cymbalta.

Cymbalta, which has been shown to significantly reduce chronic
low back pain and chronic pain due to osteoarthritis, is a
non-narcotic pain reliever that is meant to be taken once a day,
every day by people with these pain conditions.

“People with chronic musculoskeletal pain often struggle to find
a medication that works for them. The approval of Cymbalta for
chronic musculoskeletal pain by the FDA gives doctors another
option to help an underserved and suffering group of patients,”
said Michael Clark, M.D., MPH, director, Chronic Pain Treatment
Program, Department of Psychiatry and Behavioral Sciences, The
Johns Hopkins Medical Institutions.

Although the exact way that Cymbalta works to reduce chronic
musculoskeletal pain is unknown, it is believed that Cymbalta helps
lessen pain by enhancing the body’s natural pain suppressing system
by increasing the activity of serotonin and norepinephrine in the
brain and spinal cord.

In chronic musculoskeletal pain clinical studies, the most
commonly observed adverse events (those occurring in at least 5
percent of study participants taking Cymbalta and at least twice
the rate of placebo) in Cymbalta-treated patients with chronic low
back pain were nausea, dry mouth, insomnia, sleepiness,
constipation, dizziness and fatigue. The most commonly observed
adverse events in Cymbalta-treated patients with chronic pain due
to osteoarthritis were nausea, fatigue and constipation.

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