FDA Approves Cymbalta

FDA Approves Cymbalta for the Treatment of Depression

INDIANAPOLIS, Aug. 4, 2004 /PRNewswire-FirstCall/ -- The U.S. Food and Drug Administration has approved Cymbalta (duloxetine HCl; pronounced SIM-BALL-TA), judging it a safe and effective treatment for major depressive disorder, Eli Lilly and Company (NYSE: LLY) announced today.

Cymbalta, a balanced and potent reuptake inhibitor of serotonin and norepinephrine, has been studied in more than 6,000 adults with major depression worldwide. Its approval gives healthcare professionals and patients a long-awaited new option for treating the broad range of emotional and physical symptoms of depression. Today, only 25-35 percent of patients treated for depression in clinical studies experience relief from all of their disease symptoms.(1)

"Depression is a whole-body illness, but most modern antidepressants treat the emotional symptoms, such as crying and sadness, better than they treat the physical symptoms of depression," said Dr. Stephen Stahl, chairman of the Neuroscience Education Institute and adjunct professor of psychiatry at the University of California at San Diego School of Medicine. "Because of its dual action on serotonin and norepinephrine, Cymbalta offers physicians a new opportunity to help patients with depression, particularly those who experience the common physical symptoms of the disease, such as vague aches and pains."

Neurotransmitters are believed to help regulate a person's emotions and sensitivity to pain. Scientists believe that if these neurotransmitters are out of balance, a person may become depressed and be more likely to feel painful physical symptoms. The combination of emotional and painful physical effects of depression can have a tremendous negative impact on a person's quality of life.(2)

"Lilly's leadership in neuroscience and dedication to the treatment of depression is well established," said Sidney Taurel, Lilly's chairman, president and chief executive officer. "Lilly is committed to solving the world's most pressing neuroscience problems, through research programs in Alzheimer's and Parkinson's as well as through our established expertise in depression, schizophrenia, bipolar disorder and Attention- Deficit/Hyperactivity Disorder."

Lilly demonstrated Cymbalta's effectiveness in treating major depression with data from four placebo-controlled clinical studies, all in adults. The safety and efficacy of Cymbalta in children have not been studied.

Milt Meyers, a participant in a Cymbalta clinical trial, found it worked for him. "Cymbalta worked for me," Meyers said. "I felt really good for the first time in a long time. I really felt like I was on the right track." Cymbalta comes in a capsule and can be taken once a day. In clinical trials, Cymbalta was studied in a dose range of 40-120 mg per day. The recommended daily dose is 60 mg.

Duloxetine hydrochloride also is being studied for the treatment of stress urinary incontinence and diabetic neuropathic pain, conditions believed to respond to treatment with both serotonin and norepinephrine.

About Depression

Nearly 19 million Americans suffer from depression each year, making it one of the leading causes of disability according to the World Health Organization. Current medical literature suggests that patients who are successfully treated for all their depressive symptoms, including both the emotional and painful physical ones, may be more likely to achieve remission than those whose physical symptoms are not alleviated.(1),(3),(4),(5)

Patient Experience

In clinical trials, Cymbalta was safe and effective. Not all patients respond the same. The experience of the patient quoted in this release might not be typical.

Important Safety Information

Depression, as a disease, can be associated with periods when the symptoms can worsen or thoughts of suicide can emerge. Patients and their families should watch for these as well as for anxiety, agitation, panic, difficulty sleeping, irritability, hostility, aggressiveness, impulsivity, restlessness, or overexcitement and hyperactivity. Call the doctor if any of these are severe or occur suddenly. Be especially observant at the initiation of antidepressant drug therapy and whenever there is a change in dose.

Prescription Cymbalta is not for everyone. People who are allergic to duloxetine hydrochloride or the other ingredients in Cymbalta should not take it. If you are taking thioridazine or if you are taking or have recently taken a type of antidepressant called a monoamine oxidase inhibitor (MAOI), you should not take Cymbalta. It also should not be administered to patients with any hepatic insufficiency, end-stage renal disease or uncontrolled, narrow-angle glaucoma. Cymbalta ordinarily should not be prescribed to patients with substantial alcohol use. Women who are pregnant should talk with their doctor before taking Cymbalta. Nursing while taking Cymbalta is not recommended.

In clinical studies, the most common side effects were nausea, dry mouth, constipation, decreased appetite, fatigue, sleepiness and increased sweating. Most people were not bothered enough by side effects to stop taking Cymbalta. Your doctor may periodically check your blood pressure. Don't stop taking Cymbalta without talking to your doctor.

For full patient information, visit http://www.cymbalta.com/ .

About Lilly

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 http://www.lilly.com/ .

This press release contains forward-looking statements about the potential of Cymbalta for the treatment of major depressive disorder 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 prove 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.

(1) Tran PV, Bymaster FP, McNamara RK, et al. Dual Monoamine Modulation for Improved Treatment of Major Depressive Disorder, J Clin Psychopharmacology, 2003; 23: 78-86

(2) The Regents of the University of Michigan. Beyond Sadness. Bridging the gap between emotional and physical symptoms of depression. Ann Arbor, MI, 2002.

(3) Nemeroff CB et al. Duloxetine for the Treatment of Major Depressive Disorder. Psychoharmacol Bul. 2002; 36 (4):106-132.

(4) Ohayon, M., et al. Using Chronic Pain to Predict Depressive Morbidity in the General Population. Arch Gen Psychiatry 2003; 60: 39-47.

(5) Poster presented at American Psychiatric Association annual meeting. May 19, 2003. San Francisco, CA.

Posted: August 2004

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Cymbalta (duloxetine) FDA Approval History

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