The U.S. Food and Drug Administration has approved Eli Lilly's Cymbalta, a balanced and potent serotonin and norepinephrine reuptake inhibitor. Cymbalta is the first and only FDA-approved treatment for pain caused by diabetic peripheral neuropathy.
Cymbalta comes in a capsule and can be taken once a day. The recommended daily dose for Cymbalta is 60 mg. Cymbalta has not been studied in children, and therefore Lilly discourages its use in those under 18. In addition to depression and pain caused by diabetic peripheral neuropathy, duloxetine hydrochloride, the active ingredient in Cymbalta, also has been approved in Europe for the treatment of moderate to severe stress urinary incontinence, another condition believed to respond to treatment that affects serotonin and norepinephrine levels.
Diabetic peripheral neuropathy is a problem associated with long standing diabetes or poor glucose control. Peripheral neuropathy is the most common complication of diabetes mellitus, affecting up to 62% of Americans with diabetes. Diabetic peripheral neuropathy can manifest in a variety of ways but is usually characterized by burning, tingling, and numbing sensations beginning in the feet, and later affecting the legs and/or hands.
The safety and effectiveness of Cymbalta were established in two randomized, controlled studies of approximately 1074 patients. Although the mechanism of action is unknown, patients treated with Cymbalta reported a greater decrease in pain compared to placebo. In these trials, 58 percent of patients treated with Cymbalta reported at least a 30 percent sustained reduction in pain. In comparison, 34 percent of patients treated with placebo reported this magnitude of sustained pain reduction.
The most commonly reported side effects were nausea, dry mouth, constipation, and diarrhea. In some cases, patients experienced dizziness and hot flashes.