INDIANAPOLIS, May 29 Eli Lilly and Company(NYSE: LLY) has submitted a supplemental New Drug Application (sNDA) to theU.S. Food and Drug Administration (FDA) seeking approval for a new indicationfor Cymbalta(R) (duloxetine HCl) for the management of chronic pain, thecompany announced today. The submission is based on outcomes of clinicaltrials in chronic osteoarthritis pain of the knee and chronic low back pain,in addition to data from previously completed pain studies in diabeticperipheral neuropathic pain (DPNP) and fibromyalgia. Cymbalta was studied inchronic pain of at least moderate severity in adults who required dailytreatment 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 actualor potential tissue damage, or described in terms of such damage.(i) Chronicpain persists beyond acute pain or beyond the expected time for an injury toheal.(ii)
Serotonin and norepinephrine in the brain and spinal cord are believed toboth mediate core mood symptoms and help regulate the perception of pain.Based on pre-clinical studies, Cymbalta is a balanced and potent reuptakeinhibitor of serotonin and norepinephrine that is believed to potentiate theactivity of these chemicals in the central nervous system (brain and spinalcord). While the mechanism of action of Cymbalta is not fully known,scientists believe its effects on depression and anxiety symptoms, as well asits effect on pain perception, may be due to increasing the activity ofserotonin and norepinephrine in the central nervous system.
Cymbalta is approved in the United States for the acute and maintenancetreatment of major depressive disorder, the acute treatment of generalizedanxiety 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 generalizedanxiety 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 ifthey experience new or worsening depression symptoms, unusual changes inbehavior, or thoughts of suicide. Be especially observant within the first fewmonths of treatment or after a change in dose. Cymbalta is approved only foradults 18 and over.
Cymbalta is not for everyone. Patients should not take Cymbalta if theyhave recently taken a type of antidepressant called a monoamine oxidaseinhibitor (MAOI), are taking Mellaril(R) (thioridazine) or have uncontrolledglaucoma. Patients should speak with their doctor about any medicalconditions they may have, including liver or kidney problems, glaucoma, ordiabetes. Patients should tell their doctor about all their medicines,including those for migraine, to avoid a potentially life-threateningcondition. Taking Cymbalta with NSAID pain relievers, aspirin, or bloodthinners may increase bleeding risk. They also should talk to their doctorabout their alcohol consumption. Patients should consult with their doctorbefore stopping Cymbalta or changing the dose and if they are pregnant ornursing.
Patients taking Cymbalta may experience dizziness or fainting uponstanding. 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 medicationguide, visit http://www.cymbalta.com/.
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