FDA Approves Antidepressant Cymbalta (Duloxetine) to Treat Diabetic Peripheral N

Cymbalta is the first only drug approved for diabetic neuropathy and has been shown to significantly reduce 24-hour pain. Cymbalta, a balanced and potent serotonin and norepinephrine reuptake inhibitor, is the first and only FDA-approved treatment for pain caused by diabetic peripheral neuropathy. This approval came after a six-month priority review. More than 18 million Americans have diabetes and are at risk for developing persistent pain — often described as burning, stabbing or shooting pain — as a result of nerve damage believed to be caused by high blood sugar.

This is the second time in a month that the FDA has judged Cymbalta a safe and effective therapy for a major medical disorder. On Aug. 3, the agency approved Cymbalta as a treatment for major depression in adults. It’s available immediately by prescription in pharmacies across the United States for the treatment of major depression or pain associated with diabetic peripheral neuropathy.

Lilly proved Cymbalta’s safety and efficacy in the treatment of pain caused by diabetic peripheral neuropathy at doses of 60 and 120 mg per day in two randomized, 12-week, double-blind, placebo-controlled, fixed-dose studies in non-depressed adults who had the disorder for at least 6 months. However, doses of 120 mg per day, although safe and effective, were not as well tolerated as 60 mg per day. On average, patients in the studies were 60 years old, suffered from diabetes for 11 years and from related diabetic neuropathy for four years, and at the beginning of the studies, rated their pain as moderate to moderately severe.

In both studies, Cymbalta significantly reduced 24-hour average pain, compared with placebo. Improvements were noted as early as the first week of treatment and continued for the duration of the studies. In addition, Cymbalta showed rapid onset of action and sustained effect in reducing pain caused by diabetic neuropathy at both 60 mg per day and 120 mg per day, and was effective in relieving pain at night. Nighttime pain is especially troublesome to many patients with diabetic neuropathy, because it can interfere with sleep.

"Until now, we didn’t have a simple and effective therapy for patients living with diabetic neuropathic pain. Instead, we were left with medications that often required multiple dose adjustments, or for patients to take several pills throughout the day. This is difficult for many of these patients, as they already take a host of medications for their diabetes and other conditions, which can put them at increased risk for drug interactions and dose-limiting side effects," said Timothy Smith, M.D., R.Ph., Medical Director, Mercy Health Research, St. Louis, and a Cymbalta investigator. "With Cymbalta, we finally have a therapy proven to provide real relief for many of these patients, without the complicated dosing schedule."

Although Cymbalta does not change the underlying nerve damage caused by diabetic peripheral neuropathy, it does help relieve the stabbing, burning and shooting pain often associated with the disorder. Scientists believe it does this by increasing levels of serotonin and norepinephrine, two neurotransmitters, or chemical messengers, believed to be important in regulating a person’s emotions as well as sensitivity to pain. Increasing these levels in a balanced way is thought to improve the body’s natural ability to regulate pain.

It’s well tolerated, with side effects similar to SSRI’s: nausea, drowsiness, dizziness, etc. Cymbalta is contraindicated in uncontrolled narrow-angle glaucoma. It can raise BP and INCREASES levels of TCAs…avoid using together.

Approval of Lyrica (pregabalin), the next generation Neurontin, is in the works. If approved, it should be indicated for DPN…shingles pain…and as add-on therapy for partial seizures in adults. We’ll keep you posted. Cymbalta is dosed 60 mg once daily for DPN. It’s too soon to tell if it’s better than TCAs and gabapentin.
Consider recommending it first-line for DPN…or as an add-on to gabapentin.

Tell patients that controlling blood sugar and BP are helpful for preventing DPN.

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WarmFeet Kit can help with painful neuropathy and wound healing.
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