Lilly's Cymbalta Receives Approval to Treat Diabetic 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.

"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.(1) "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 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.

"We know that Cymbalta as an antidepressant is effective at treating both the emotional and painful physical symptoms of depression," said Stephen Stahl, M.D., Ph.D., chairman of the Neuroscience Education Institute and adjunct professor of psychiatry at the University of California at San Diego School of Medicine. "Seeing significant benefit in diabetic neuropathic pain, among patients who did not have depression, helps confirm that this drug has a positive impact on pain that is separate from improvement in mood."

About Cymbalta

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.

Cymbalta should not be confused with Symbyax(TM) (pronounced SIMM-bee-ax), a medicine for bipolar depression also marketed by Lilly. Cymbalta is available in 20 mg, 30 mg and 60 mg capsules. Symbyax is a combination of olanzapine, the active ingredient in Zyprexa(R), and fluoxetine, the active ingredient in Prozac(R). Symbyax is available in capsules of 6 mg/25 mg (olanzapine/fluoxetine), 12 mg/25 mg, 6 mg/50 mg and 12 mg/50 mg.

About Diabetic Peripheral Neuropathy

According to the National Institute of Diabetes & Digestive & Kidney Diseases, approximately half of those with diabetes have some form of nerve damage, or neuropathy, but not all will develop symptoms. While nerve problems can occur at any time, the highest rates are among those who have had diabetes for at least 25 years. People who have had problems controlling their blood sugar levels, have high blood pressure, are overweight, have high levels of blood fat, or are over the age of 40, may also have a greater risk of developing diabetic peripheral neuropathy.

Symptoms can include numbness, tingling or pain and weakness in the toes, feet, legs, hands, arms and fingers. These symptoms are often worse at night.(2)

Source: Eli Lilly and Co.