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FDA approves duloxetine hydrochloride to treat diabetic peripheral neuropathy
Treatment is the first drug specifically approved to treat the pain associated with diabetic peripheral neuropathy.
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The FDA recently approved duloxetine hydrochloride (Cymbalta, Eli Lilly) for the treatment of the pain associated with diabetic peripheral neuropathy.
This is the first drug approved by the FDA specifically to treat patients for the pain caused by diabetic peripheral neuropathy.
The approval for duloxetine hydrochloride came after a six-month priority review by the FDA. The approval was based on the results of two randomized, controlled clinical trials. These trials included a total of 1,074 patients with diabetic peripheral neuropathy. All patients included in the studies had had diabetic peripheral neuropathy for at least six months. The average age of the patients was 60; the average time since diagnosis of diabetes was 11 years. Furthermore, all study patients rated their pain from diabetic peripheral neuropathy as moderate to moderately severe at baseline.
Patients were randomized to receive either treatment with duloxetine or a placebo. Patients in the duloxetine group received doses of 60 mg/day or 120 mg/day. The trials lasted for 12 weeks.
Decrease in pain
The results demonstrated that patients who were given duloxetine reported a greater decrease in pain compared with patients given the placebo. Fifty-eight percent of patients treated with duloxetine reported experiencing at least a 30% sustained reduction in pain. In comparison, 34% of patients treated with placebo reported experiencing this level of pain reduction.
Patients taking duloxetine reported improvements as early as the first week of treatment and improvements continued for the duration of the studies. Some mild side effects, including nausea, dry mouth, constipation, diarrhea, dizziness and hot flashes were reported.
Boris Draznin, MD, PhD, associate chief of staff for research and development at the Veterans Affairs Medical Center in Denver, and member of the Endocrine Today editorial advisory board, said he thinks this new approval signifies an improvement in treatment for patients with diabetes. “This will be a new and reasonably potent drug to treat a difficult problem,” Draznin told Endocrine Today. “I expect physicians to like it.”
Timothy Smith, MD, RPh, medical director at Mercy Health Research in St. Louis, and one of the researchers who worked on the clinical trials for duloxetine, said the new approval means patients with diabetic peripheral neuropathy now have a simple treatment option. “Until now, we didn’t have a simple and effective therapy for patients living with diabetic neuropathic pain,” Smith said in a press release. “Instead, we were left with medications that often required multiple dose adjustments, or for patients to take several pills throughout the day. With [duloxetine hydrochloride], we finally have a therapy proven to provide real relief for many of these patients, without the complicated dosing schedule.”
Duloxetine was also recently approved for the treatment of major depression in adults.