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Cymbalta to Treat Pain Caused by Diabetic Peripheral Neuropathy December 2004 FDA grants priority approval to first medicine to treat common, painful complication of diabetes The U.S. Food and Drug Administration (FDA) has approved the antidepressant Cymbalta® (duloxetine HCl; pronounced SIM-BALL-TA), judging it safe and effective for the management of diabetic peripheral neuropathic pain, a symptom of nerve damage that affects up to 5 million Americans, Eli Lilly and Company announced today. Only FDA-Approved Treatment 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. "It has been a phenomenal month for Lilly, with four drug approvals since early August," said Sidney Taurel, Lilly's chairman, president and chief executive officer. "Our long-term investment in drug research continues to pay dividends, both to the company and, more importantly, to patients around the world suffering from a variety of illnesses." 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 August 3rd, 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. Double-Blind Placebo-Controlled Studies Lilly proved Cymbalta's safety and efficacy in the treatment of pain caused by diabetic peripheral neuropathy at doses of 60 and 120mg 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 60mg 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 120mg 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. Simple and Effective "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." Pain Regulation 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. |
