Approval of Cymbalta for treatment of major depressive disorder

Aug 5 2004

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 have announced.

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.