Eli Lilly and Company: Cymbalta(R) Significantly Reduced Chronic Low Back Pain in New Study

INDIANAPOLIS, Feb. 3 /PRNewswire-FirstCall/ -- In a new study, 60 mg of Cymbalta(R) (duloxetine HCl) taken once daily significantly reduced chronic low back pain, as measured by the Brief Pain Inventory (BPI) average pain rating, compared with placebo.(1) The data were presented today at the annual meeting of the American Academy of Pain Medicine (AAPM) in San Antonio, Texas.

The most common adverse events (those occurring in more than 5 percent of study participants) in duloxetine-treated patients were nausea, headache, dry mouth, constipation and dizziness. A total of 41 patients in the study discontinued due to adverse events - 30 in the duloxetine-treated group and 11 in the placebo-treated group. Adverse events were similar to those seen in previous duloxetine studies.

According to the International Association for the Study of Pain (IASP), pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage.(3) Chronic pain is defined as pain that persists beyond acute pain or beyond the expected time for an injury to heal.(4)

About Cymbalta

Serotonin and norepinephrine in the brain and spinal cord are believed to both mediate core mood symptoms and help regulate the perception of pain. Based on preclinical studies, Cymbalta is a balanced and potent reuptake inhibitor of serotonin and norepinephrine that is believed to potentiate the activity of these chemicals in the central nervous system (brain and spinal cord). While the mechanism of action of Cymbalta is not known, scientists believe its effects on depression and anxiety symptoms, as well as its effect on pain perception, may be due to increasing the activity of serotonin and norepinephrine in the central nervous system.

Indications and Important Safety Information for Cymbalta

Important Safety Information

Antidepressants can increase suicidal thoughts and behaviors in children, adolescents, and young adults. Suicide is a known risk of depression and some other psychiatric disorders. Patients should call their doctor right away if they experience new or worsening depression symptoms, unusual changes in behavior, or thoughts of suicide. Be especially observant within the first few months of treatment or after a change in dose. Cymbalta is approved only for adults 18 and over.

The most common side effects of Cymbalta include nausea, dry mouth, sleepiness, and constipation. This is not a complete list of side effects. Cymbalta may cause sleepiness and dizziness. Until patients know how Cymbalta affects them, they should not drive a car or operate hazardous machinery.

For full Prescribing Information, including Boxed Warning and medication guide, visit http://www.cymbalta.com.

This press release contains forward-looking statements about the potential of Cymbalta for the management of chronic low back pain, and reflects Lilly's current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. There is no guarantee that the product will continue to be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's filings with the United States Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.

P-LLY

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