Cymbalta(R) Significantly Reduced Diabetic Neuropathic Pain in Second Placebo-controlled Study
29 April 2004 - 1:35AM
PR Newswire (US)
Cymbalta(R) Significantly Reduced Diabetic Neuropathic Pain in
Second Placebo-controlled Study SAN FRANCISCO, April 28
/PRNewswire-FirstCall/ -- The investigational drug Cymbalta(R)
(duloxetine hydrochloride), a selective serotonin norepinephrine
reuptake inhibitor, significantly reduced pain associated with
diabetic neuropathy, with improvement seen as early as one week,
according to a new study presented today at the American Academy of
Neurology annual meeting. Because serotonin and norepinephrine are
involved in mood regulation as well as pain modulation, studies in
painful diabetic neuropathy, in which patients with depression or
other mood disorders were excluded, were conducted to test the
hypothesis that Cymbalta may demonstrate an independent analgesic
effect. The data presented today confirms a previous study in which
Cymbalta, at doses of 60 mg once a day or 120 mg (60 mg twice
daily) significantly reduced diabetic neuropathic pain versus
placebo. In previous depression-focused studies, patients treated
with Cymbalta experienced significant improvement on both the
emotional and painful physical symptoms of depression, compared
with patients who received sugar pills. "More than 18 million
Americans have diabetes, which puts them at increased risk for
diabetic neuropathy, an often painful condition for which there is
no approved treatment," said J. F. Wernicke, Ph.D., M.D., Medical
Advisor, Lilly Research Laboratories. "In this study, Cymbalta
provided relief quickly for many patients living with painful
symptoms of diabetic neuropathy. Having multiple studies
demonstrating clinically significant response in a pure pain
population further highlights the positive impact of Cymbalta on
these important symptoms." Serotonin and norepinephrine are
believed to mediate pain perception in spinal cord pathways. These
neurotransmitters also are believed to mediate symptoms of
depression and stress urinary incontinence, two other conditions
for which Cymbalta is being studied. Study highlights include: *
Cymbalta patients reported significant reductions in pain, compared
with those taking placebo, after one week of active therapy (p