PRNewswire-FirstCall (Apr 28, 10:36 AM)  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<.001).

* Cymbalta 60 mg once and twice daily also significantly improved several other symptoms in these patients, including their own assessment of global functioning (Patient Global Impression of Improvement (p<.05, p<.001, respectively)), and the overall score of pain interference (Brief Pain Inventory Interference Average of Seven (p<.05, p<.001, respectively)).

* Patients treated with Cymbalta 60 mg once and twice daily were significantly more likely to respond to treatment than patients taking sugar pills (63 percent and 69 percent vs. 42 percent, respectively). Response was defined as a 30 percent reduction from baseline in 24-Hour Average Pain Severity on a 0-10 self-rating scale.

* In this study, Cymbalta was safe and well tolerated at both doses. Discontinuation rates due to adverse events were 15 percent for Cymbalta 60 mg once daily and 18 percent for Cymbalta twice daily in comparison to 7.4 percent for placebo.

Methods

In a 12-week randomized multi-center double-blind study, patients (N=334) with diabetic neuropathy were randomly selected to receive placebo or Cymbalta at 60 mg once or twice daily. Patients with depression were excluded from the study. The primary efficacy measure was the reduction in the weekly mean of the 24-hour average pain scores, as measured by a 0-10 Likert Scale and calculated from the patient's diary. Secondary efficacy measures included pain severity for 24-hour worst pain and night pain, Patient Global Impression of Improvement, Brief Pain Inventory severity scales, Sensory Portion of the Short Form McGill Pain Questionnaire, Hamilton Depression Rating Scale (HAMD17), Clinical Global Impression of Severity and Dynamic Allodynia. Safety was evaluated through the collection and reporting of discontinuation rates, treatment-emergent adverse events, vital signs and weight, electrocardiograms, laboratory analyses and an electrophysiology assessment.

About Cymbalta

In placebo-controlled clinical trials for the treatment of diabetic neuropathic pain, the most commonly observed adverse events (incidence of 5 percent or greater and at least twice placebo) for Cymbalta vs. placebo (n = 568 vs. 223) in doses of 20 to 120 mg per day were: nausea (24 percent vs. 9 percent), sleepiness (16 percent vs. 5 percent), dizziness (13 percent vs. 6 percent), constipation (11 percent vs. 3 percent), dry mouth (9 percent vs. 4 percent), excessive sweating (7 percent vs. 2 percent) and asthenia (5 percent vs. 1 percent). The overall discontinuation rate due to adverse events for Cymbalta vs. placebo was 14 percent vs. 7 percent. Nausea (3.5 percent vs. 0.4 percent), dizziness (1.6 percent vs. 0.4 percent), sleepiness (1.6 percent vs. 0 percent), and fatigue (1.1 percent vs. 0 percent) were the common adverse events reported as reasons for discontinuation and considered to be drug-related (i.e. discontinuation occurring in at least 1 percent of the duloxetine treated patients and at a rate at least twice that of placebo.).

About Lilly

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers -- through medicines and information -- for some of the world's most urgent medical needs. Additional information about Lilly is available at http://www.lilly.com/ .

This press release contains forward-looking statements about the potential of an investigational compound, duloxetine, for the treatment of diabetic neuropathic pain and reflects Lilly's current beliefs. However, as with any pharmaceutical product under development, there are substantial risks and uncertainties in the process of development and regulatory review. There is no guarantee that the product will receive regulatory approvals, or that the regulatory approval will be for the indication(s) anticipated by the company. There is also no guarantee that the product will prove to be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's filing with the United States Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.

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Eli Lilly and Company

CONTACT: David Shaffer (US), office: +1-317-651-3710; cell:+1-317-997-0632, or Jennifer Yoder (Global), office: +1-317-433-3445; cell:+1-317-652-0912, both of Eli Lilly and Company