Cymbalta

FOR IMMEDIATE RELEASE
(Free-Press-Release.com) August 9, 2004 -- The U.S. Food and Drug Administration (FDA) has approved Cymbalta (duloxetine HCl; pronounced SIM-BALL-TA), judging it a safe and effective treatment for major depressive disorder.



http://www.usadrugcentral.com

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



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 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.



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.



UDC

cymbalta