FDA Approves Cymbalta(R) for Maintenance Treatment of Major Depressive Disorder

INDIANAPOLIS, Nov. 30 /PRNewswire-FirstCall/ -- Eli Lilly and Company

(NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA)has approved Cymbalta(R) (duloxetine HCl) for the maintenance treatment ofmajor depressive disorder (MDD) in adults.

"Relapse, the re-emergence of depressive symptoms after a successfultreatment of depression, is a significant clinical concern," says DougWilliamson, M.D., Cymbalta associate medical director for Eli Lilly andCompany. "This approval from the FDA is important because data from ourCymbalta clinical trial demonstrate that continuing to treat the patientdelays the time to possible relapse."

Treating the broad range of depression symptoms may minimize the presenceof residual symptoms (e.g., anxiety, guilt and low self-esteem) and can helpdelay the time to relapse(1). Common symptoms of depression can includesadness, loss of interest, fatigue, changes in appetite or weight, or bodilyaches and pains.

"Once an episode of depression has been successfully treated, it isimperative that the symptoms do not return," said Lauren Marangell, M.D., aninternationally recognized expert on depression and other mood disorders and adistinguished scholar at Lilly. "The American Psychiatric Association hasrecommended maintenance of antidepressant treatment to help decrease thechance of relapse."

The efficacy and safety of Cymbalta for maintenance treatment of majordepression was established in a double-blind, placebo-controlled clinicaltrial. Patients with major depression in the trial (533 patients) receivedCymbalta 60 mg once daily. After 12 weeks, 278 patients met the criteria forentering the continuation phase and were randomly assigned to either Cymbaltaat the same dose or to a sugar pill for 6 months. Patients on Cymbaltaexperienced a statistically longer time to relapse of depression than didpatients on placebo. Relapse was defined as an increase of two or more pointson the Clinical Global Impression - Severity scale (CGI-S) compared with thatobtained at week 12, and also meeting the criteria for major depressivedisorder for two consecutive visits.

In this study, nausea was the most frequently reported side effect (alsoreferred to as a treatment-emergent adverse event) during the acute phase andwas reported as a reason for discontinuation for 2.1 percent of patients. Inthe continuation phase, there were no significant differences in reported sideeffects between patients taking Cymbalta compared with those taking sugarpills. Among patients who completed the first 12 weeks of the trial andentered the continuation phase, 3.6 percent reported side effects as reasonsfor discontinuation over the next 26 weeks (continuation phase) of thestudy.(2)

Cymbalta, a member of a class of drugs commonly referred to as serotoninand norepinephrine reuptake inhibitors (SNRI), has been studied in more than27,000 patients worldwide. Cymbalta is already approved for the acutetreatment of major depressive disorder, the management of diabetic peripheralneuropathic pain, and for the treatment of generalized anxiety disorder, allin adults. More than 9 million adults in the United States have beenprescribed Cymbalta since approval.

About Cymbalta

Serotonin and norepinephrine in the brain and spinal cord are believed toboth mediate mood symptoms of depression and help regulate the perception ofpain. Based on pre-clinical studies, duloxetine is a balanced and potentreuptake inhibitor of serotonin and norepinephrine that is believed topotentiate the activity of these chemicals in the central nervous system

(brain and spinal cord). While the mechanism of action of duloxetine is notfully known, scientists believe its effects on depression and anxietysymptoms, as well as its effect on pain perception, may be due to increasingthe activity of serotonin and norepinephrine in the central nervous system.

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 or glaucoma.Patients should tell their doctor about all of their medicines, includingthose for migraine to avoid a potentially life-threatening condition, andNSAIDs, aspirin or blood thinners due to an increased risk of bleeding. Theyalso should talk to their doctor about their alcohol consumption. Patientsshould consult with their doctor before stopping Cymbalta or changing the doseand if they are pregnant or nursing.

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, visithttp://www.cymbalta.com/.

About Eli Lilly and Company

Lilly, a leading innovation-driven corporation, is developing a growingportfolio of first-in-class and best-in-class pharmaceutical products byapplying the latest research from its own worldwide laboratories and fromcollaborations with eminent scientific organizations. Headquartered inIndianapolis, Ind., Lilly provides answers -- through medicines andinformation -- for some of the world's most urgent medical needs. Additionalinformation about Lilly is available at www.lilly.com.

P-LLY

This press release contains forward-looking statements about the potentialof Cymbalta for the maintenance treatment of major depressive disorder, andreflects Lilly's current beliefs. However, as with any pharmaceutical product,there are substantial risks and uncertainties in the process of developmentand commercialization. There is no guarantee that the product will continue tobe commercially successful. For further discussion of these and other risksand uncertainties, see Lilly's filings with the United States Securities andExchange Commission. Lilly undertakes no duty to update forward-lookingstatements.

(1) Nierenberg, A. Long-Term Management of Chronic Depression. J Clin

Psychiatry 2001; 62 (Suppl 6):17-20.

(2) Perahia DG, et al. 2006. Duloxetine in the prevention of relapse of

major depressive disorder: double-blind placebo-controlled study. Br

J Psychiatry 188:346-353.

(Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )SOURCE Eli Lilly and CompanyTamara Hull of Eli Lilly and Company, +1-317-651-9116, or mobile,+1-317-614-5132