Market Wire - 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 (duloxetine HCl) for the management of chronic pain, the
company announced today. 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.
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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 (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 www.cymbalta.com .
For full Prescribing Information, including Boxed Warning and medication
guide, visit http://www.cymbalta.com/ .
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 www.lilly.com .
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.
(i) International Association for the Study of Pain. “IASP Pain
Terminology” Available at: http://www.iasp-pain.org/AM/Template.cfm?Section=General_Resource_Links&Template=/CM/HTMLDi
splay.cfm&ContentID=3058#Pain . Accessed on 5/27/08.
