Lilly Submits Cymbalta(R) Supplemental New Drug Application For Chronic Pain To U.S. Food And Drug Administration

Eli Lilly and Company
(NYSE: LLY) has submitted a supplemental New Drug Application (sNDA) to the
U.S. Food and Drug Administration (FDA) seeking approval for a new
indication for Cymbalta(R) (duloxetine HCl) for the management of chronic
pain, the company announced. The submission is based on outcomes of
clinical trials in chronic osteoarthritis pain of the knee and chronic low
back pain, in addition to data from previously completed pain studies in
diabetic peripheral neuropathic pain (DPNP) and fibromyalgia. Cymbalta was
studied in chronic pain of at least moderate severity in adults who
required daily treatment for an extended period of time.



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.(i) Chronic pain persists beyond acute pain or beyond the expected
time for an injury to heal.(ii)



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 pre-clinical 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
fully 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.



Cymbalta is approved in the United States for the acute and maintenance
treatment of major depressive disorder, the acute treatment of generalized
anxiety disorder and the management of diabetic peripheral neuropathic
pain, all in adults (18+). Cymbalta is not approved for use in pediatric
patients.



Important Safety Information




Cymbalta is approved to treat major depressive disorder and generalized
anxiety disorder and manage diabetic peripheral neuropathic pain.
Antidepressants can increase suicidal thoughts and behaviors in children,
adolescents and young adults. 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.
















Cymbalta is not for everyone. Patients should not take Cymbalta if they
have recently taken a type of antidepressant called a monoamine oxidase
inhibitor (MAOI), are taking Mellaril(R) (thioridazine) or have
uncontrolled glaucoma. Patients should speak with their doctor about any
medical conditions they may have, including liver or kidney problems,
glaucoma, or diabetes. Patients should tell their doctor about all their
medicines, including those for migraine, to avoid a potentially
life-threatening condition. Taking Cymbalta with NSAID pain relievers,
aspirin, or blood thinners may increase bleeding risk. They also should
talk to their doctor about their alcohol consumption. Patients should
consult with their doctor before stopping Cymbalta or changing the dose and
if they are pregnant or nursing.



Patients taking Cymbalta may experience dizziness or fainting upon
standing. The most common side effects of Cymbalta include nausea, dry
mouth, sleepiness and constipation.



This is not a complete list of side effects.



For full Patient Information, visit cymbalta.



For full Prescribing Information, including Boxed Warning and
medication guide, visit cymbalta.



About Eli Lilly and Company



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 lilly.



P-LLY



This press release contains forward-looking statements about the
potential of Cymbalta for the management of chronic 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 receive
regulatory approval for chronic pain, or that it 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.


References



(i) International Association for the Study of Pain.



(ii) American Pain Society. "Pain Control in the Primary Care Setting."
2006:15.


Eli Lilly and Company

lilly


View drug information on Cymbalta.