Monday, November 5, 2012

FDA Approves Cymbalta for Neuropathic Pain Associated With Diabetes

The Food and Drug Administration (FDA) announced the approval of Cymbalta (duloxetine hydrochloride) capsules for the management of the pain associated with diabetic peripheral neuropathy. This is the first drug specifically approved for this indication. Cymbalta received a priority review. "Diabetes affect millions of Americans," said Dr. Lester M. Crawford, Acting FDA Commissioner. "With this new treatment we will hopefully be able to help relieve the pain associated with this terrible disease." 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, 51 percent of patients treated with Cymbalta reported at least a 30 percent sustained reduction in pain. In comparison, 31 percent of patients treated with placebo reported this magnitude of sustained pain reduction. The most commonly reported side effects were nausea, somnolence, dizziness, decreased appetite, and constipation. In some cases, patients experienced dizziness and hot flashes. Cymbalta is manufactured by Eli Lilly and Company in Indianapolis , Ind.
I have had chronic pain/numbness/tingling sensations in the left side of my face for over 15 years. It was slight when it first started, but turned really bad around 2005. I have been on a Vicodin, Tramadol, Fioricets "cocktail" for 8 years. I tried Neurontin for 5 months but it made me sluggish, lazy, and depressed. Neurontin didn't solve anything. Last week a Neuroligist strongly suggested I try Cymbalta, and ease off all other presciption/non prescription pain killers. Within 24 hours I noticed a significant easing of pain sensations in the area of concern, and I have reduced my pain killer intake by 50%, and will cut it down to zero in another week to ten days. This happened in only five days of one 30mg pill a day. A miracle for me.


  1. diabetic neuropathic pain results from damage or disease affecting the somatosensory system.[1] It may be associated with abnormal sensations called dysesthesia, and pain produced by normally non-painful stimuli (allodynia).

  2. Painful diabetic neuropathic pain is a common complication of diabetes and can affect many aspects of life and severely limit patients' daily functions.

  3. diabetic neuropathic pain can be classified as peripheral, autonomic, proximal, or focal. Each affects different parts of the body in various ways.