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.

Cymbalta Approved for Fibromyalgia

Eli Lilly said Monday that its antidepressant Cymbalta (duloxetine) has been approved by the U.S. Food and Drug Administration to treat fibromyalgia, a chronic disorder with symptoms including widespread muscle pain and tenderness.

The condition affects about 2 percent of the American population, or about 5 million people, mostly women. While its cause is unknown and there is no known cure, it's believed it may be related to a combination of changes in brain and spinal cord chemistry, genetic factors, and stress, the company said in a statement.

Cymbalta affects production of two naturally occurring brain substances, serotonin and norepinephrine. In addition to affecting mood, it's believed these substances are part of the body's natural pain-surpressing system, Lilly said.

In a pair of three-month trials involving 874 people with fibromyalgia, Cymbalta significantly reduced pain levels, compared with a non-medicinal placebo, the company said. Common adverse reactions included nausea, dry mouth, constipation, decreased appetite, and sleepiness.

Cymbalta also is approved to treat major depressive disorder and generalized anxiety disorder, and a form of nerve pain in diabetics, all in adults 18 and older.

The pain is gone. It took around 3 1/2 weeks to 'kick in' fully. Most days are great. I can work again. I can play with my kids again. I'm living again. Cymbalta worked for my fibromyalgia pain when nothing else would.

I share the same experiences as other reviewers. Fibromyalgia was finally diagnosed 10 years ago. I started taking Cymbalta one year ago and it has been a life changing event. It allowed me to get off the two opiate pain medications I was on. No need to tell anyone the impact it has on my life. It's a priceless medicine.

Cymbalta Approved for Chronic Joint and Muscle Pain

Cymbalta (duloxetine hydrochloride) has received expanded approval from the U.S. Food and Drug Administration to treat chronic musculoskeletal pain, stemming from conditions including lower back pain and osteoarthritis.

Since its approval as an antidepressant in 2004, some 30 million people in the United States have used the drug, the agency said in a news release. The FDA also has sanctioned Cymbalta for diabetic pain, generalized anxiety disorder and fibromyalgia.

The most common side effects from Cymbalta use include nausea, dry mouth, insomnia, drowsiness, constipation, fatigue, and dizziness. More serious adverse reactions have included liver damage, allergic reaction, pneumonia, depressed mood, and suicidal thoughts and behavior, the agency said.

This drug is fantastic. I had neuropathic pain and depression, due to the chronic pain, for over six months. I tried NSAIDS and other drugs which did little, if anything. Cymbalta really saved me. I tolerated it well and had few side effects, dry mouth and a little wired for the first week on it but that was it. It did reduce sexual performance and cause difficulty with orgasm, but it was worth it. After 10 months I got off of it and everything returned but the pain.
Cymbalta provided amazing relief for my neuropathic pain and depression though it also seemed to have bad side effects. The night terrors I experienced were unimaginable and occurred almost nightly. I had taken this medication for over a year and after choosing to discontinue it, the withdrawal symptoms that followed seemed severe. I would advise a cautious approach.
 was originally prescribed Cymbalta for relief of pain caused by neuropathy in my leg. I have bipolar disorder. At the time I was unaware it was an anti-depressant. Bipolar patients should monitor themselves for symptoms of mania while taking Cymbalta. I was thrown into a wild episode of mania within 3 weeks of taking a 60 mg dose of Cymbalta.

Cymbalta Might Ease Chemo-Linked Pain

Cancer patients on certain chemotherapies often experience a painful tingling in their extremities called peripheral neuropathy, and a new study suggests the antidepressant Cymbalta may be the first treatment to work against the condition.

In the small study, 59 percent of patients who'd experienced peripheral neuropathy said that they gained relief after taking Cymbalta (duloxetine), compared to 39 percent who took a "dummy" pill.

Taking Cymbalta daily "decreases chronic chemotherapy-induced neuropathy and pain severity in the majority of patients who take it and it improves function and quality of life," said study author Ellen Lavoie Smith, an assistant professor at the University of Michigan's School of Nursing. She said the drug is also "very well tolerated" by most patients.

Smith spoke at a news briefing Sunday at the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago. The findings were to be formally presented Monday.

One expert was also encouraged by the findings.

"Patients undergoing chemotherapy have to face a multitude of changes, both physically and mentally, and improving their quality of life during this phase of their lives is of utmost importance," said Dr. Stephanie Bernik, chief of surgical oncology at Lenox Hill Hospital in New York City. "It is extremely exciting that there is now a drug we can offer that can reduce this terrible side effect and make chemotherapy more tolerable."

Chemotherapy-induced peripheral neuropathy involves a tingling and numbness in the hands and feet, and is a common side effect of chemotherapies such as the platinum-based medications or taxanes (drugs such as Taxol or Taxotere). It is estimated that up to 30 percent of patients who receive these medications experience neuropathy, and the side effect is a contributing factor to patients dropping treatment.

In the worst cases, "some patients endure this painful neuropathy for months and possibly as long as years following completion of therapy," Smith said. "So it's chronic, it's very distressing and disabling, and then in addition there's really nothing to date that we know is effective in treating the problem."

The new study, funded by the U.S. National Cancer Institute, involved 231 cancer patients who had developed peripheral neuropathy after taking either the platinum-based cancer drug oxaliplatin or the taxane paclitaxel (Taxol). They were randomly assigned to receive either a half-dose of Cymbalta starting at 30 milligrams (mg) per day for the first week, then the full, 60-mg dose for another four weeks; or a placebo pill for five weeks.

According to Smith, Cymbalta is thought to help ease neuropathy by altering levels of brain neurotransmitters linked to nerve function. The drug is already used to treat diabetic peripheral neuropathy, the study noted.

The study found that more patients taking Cymbalta were more likely to report a decrease in neuropathic symptoms compared to those on the placebo. Smith added that "33 percent of patients in the duloxetine group had at least a 30 percent decrease in pain and 21 percent of patients had at least a 50 percent decrease in pain" -- numbers much higher than those on the placebo pill.

Patients taking Cymbalta also "had a greater decrease in the amount that pain interfered with some very important things -- with general activity, with movement, walking, normal work, relations with people, sleep and enjoyment of life," Smith said.

Still, not everyone in the study gained a benefit and some patients actually experienced an increase in tingling/numbness during the trial. However, this was less frequent for those on Cymbalta (11 percent) than on a placebo (28 percent), the authors said.

Cymbalta may come with side effects of its own, notably fatigue, and 11 percent of patients on Cymbalta reported moderate to severe fatigue versus 3 percent of those taking the dummy pill.

Smith said her team is now working on trying to "predict who might respond [to Cymbalta] so that we can target the use of this drug to the people who are mostly likely to benefit."

Another oncologist said he was heartened by these initial results.

"It's true there are not many great treatments for neuropathy, something that is a common side effect of some of the chemotherapy medications that we use for the most common cancers: lung, colon and breast," said Dr. Cardinale Smith, of the division of hematology/medical oncology at the Tisch Cancer Institute and Mount Sinai School of Medicine, in New York City. "This study adds evidence of a medication that appears to have good efficacy in treating what can be a debilitating toxicity."

ASCO spokesman Dr. Nicholas Vogelzang, who moderated the press briefing, said he sees far too much neuropathy in his patients, many of whom receive platinum-based chemotherapy.

I used Cymbalta for a year. The first 8 months were great in alleviating my all-over pain, which is why I was taking it. After that, slowly it came back until I asked to be taken off. In the first few days I had pounding of my heart which was so bad I never slept all night. MD put me on another blood pressure pill which helped after upping the dosage a couple times. After weaning off, heart pounding & insomnia started again.

Lilly Pursues OK for Cymbalta for Chronic Pain

Lilly Pursues OK For Cymbalta For Chronic Pain: Drug maker will take case to treat chronic pain to FDA panel [The Indianapolis Star]

From Indianapolis Star (IN) (August 18, 2010)

Aug. 18--As its pipeline of new drugs continues to sputter, Eli Lilly and Co. is pushing hard to squeeze more uses out of its existing products.

The latest example is Cymbalta, an antidepressant that Lilly hopes to market for chronic pain. On Thursday, the Indianapolis drug maker will make its case before a Food and Drug Administration advisory committee that the drug is a safe, effective treatment for chronic pain, an ailment that affects up to 45 million Americans.

Getting federal approval to market the drug for chronic back or knee pain could add more than $500 million in annual sales, according to Seamus Fernandez, a drug analyst at Leerink Swann & Co. in Boston. Some other analysts say Lilly increasingly needs to get more uses out of its medicine chest.

"Getting another approval for Cymbalta would be very helpful, no doubt about that," said Barbara Ryan, a drug analyst at Deutsche Bank in Greenwich, Conn. "Lilly is not getting anyone excited about its pipeline in the short term."

Cymbalta already is the nation’s fourth-most advertised prescription drug and Lilly’s second-best-selling product, with sales last year of $3.1 billion, up 14 percent from a year earlier. The drug is currently approved for four conditions: depression, anxiety, fibromyalgia and diabetic nerve pain.

But Lilly is making no bones that Cymbalta has room to grow. Lilly’s chief financial officer, Derica Rice, told analysts last year that getting approval for chronic pain would provide "significant growth" that could bring about "a new phase of Cymbalta’s life cycle."

Only one in four people receives adequate treatment for the condition, the company said. The company studied Cymbalta’s use in more than 2,400 patients for chronic pain in 12 late-stage clinical trials.

"We believe it’s important for those patients to have as many different treatment options as possible, because the responses to medicine can be highly individualized," said Dr. James M. Martinez, Lilly’s medical director for Cymbalta.

An FDA staff report released this week concluded that the drug helps people with chronic pain and isn’t linked to any new side effects. No patients died while taking the drug during clinical trials.

Still, some analysts expect the panel to look closely at the drug’s benefit-risk profile. Like all antidepressants, Cymbalta carries a black-box warning for increased risk of suicide among people younger than 25.

"It’s pretty clear that Cymbalta is an effective treatment for depression and for anxiety, but given its safety profile, should it be a widely used medication for pain?" said Robert Hazlett, a drug analyst for BMO Capital Markets in New York. "I’m sure discussion will be had about whether there is good, clear data and how to manage such a risk."

A green light from the FDA would mark the end of a long, bumpy road on the chronic pain indication for Cymbalta. In 2008, Lilly withdrew an application after the FDA questioned the methodology and dosing of some of the company’s trials. The company later submitted a new application, with more data. In January, the FDA canceled a meeting for Lilly’s request, saying it needed more time to review the new information.

And Lilly might approach the FDA again for another proposed use down the road. The company has studied Cymbalta for a raft of other possible uses, including urinary stress incontinence, irritable bowel syndrome and pain associated with multiple sclerosis and breast cancer, according to the web site

The company declined to comment about sales projections or possible future uses of Cymbalta. Nor did it say whether it expects to get FDA approval.
Cymbalta provided amazing relief for my neuropathic pain and depression though it also seemed to have bad side effects. The night terrors I experienced were unimaginable and occurred almost nightly. I had taken this medication for over a year and after choosing to discontinue it, the withdrawal symptoms that followed seemed severe. I would advise a cautious approach.

Fibromyalgia Symptoms

Fibromyalgia can cause pain and stiffness in the muscles and joints almost anywhere in the body, including the trunk, neck, shoulders, back and hips. People often have pain between the shoulder blades and at the bottom of the neck. Pain may be either a general soreness or a gnawing ache, and stiffness is often worst in the morning. Typically, people also complain of feeling abnormally tired, especially of waking up tired, although they have slept well. People with fibromyalgia also have tender points, which are specific spots on the body that are painful to touch. Some people report symptoms of irritable bowel syndrome, depression, anxiety and headache. For research studies, the American College of Rheumatology (ACR) has established criteria for fibromyalgia. To meet these criteria, one must have at least 3 months of unexplained, body-wide pain and at least 11 of 18 tender points in specific locations.

After asking about your symptoms, your doctor will check for swelling, redness and impaired movement in parts of your body where you're having pain. Your doctor will check for tenderness and pain in the ACR-designated tender points.

Your doctor will ask detailed questions about your medical history and examine you to rule out other conditions or diseases that could explain your symptoms.

Because the ACR criteria were developed for research studies, physicians who are not participating in research often diagnose the illness without meeting these strict criteria, but only after they have been unable to find alternative causes of the pain and fatigue.

I have been on Cymbolta for 8 weeks, I suffer from medical anxiety. I have not felt this good in years. the first 2 weeks I did have a lot of side effects swetting, dizziness, insomnea, upset stomach, but after that I started feeling better. I have lost 20 lbs because I no longer feel hunger all the time. I feel like I did 20 years ago so much happier. I can't rave enough about it.
Cymbalta I felt more like myself (Unlike Welbutrin)and it made me FOCUS more at school/work. The cons to the drug,(had to wait 3 days to fill my prescription)thus if you quit cold-turkey, you could have severe brain zaps (it feels like an electrical current running through your brain and it occurs a few times per hour when the withdrawals begin). Also it didn't give me a burst of energy like Wellbutrin did, but Cymbalta made me feel more emotional towards others(rather than being numb to world)


People with fibromyalgia have widespread pain, aches and stiffness in muscles and joints throughout the body along with unusual tiredness. There is no known cause of fibromyalgia. In addition, doctors can't find a physical reason for the symptoms. Blood tests, X-rays and other tests usually are normal in people with fibromyalgia.

Fibromyalgia is a controversial illness. Some physicians don't believe that it's a medical illness but may be a reflection of psychological distress or stress. However, there's no proof of a psychological cause either. Until we have a better understanding of the disorder, it's likely to remain controversial.

It may be that fibromyalgia has more than one cause. Some researchers have suggested that it's related to abnormalities in a non-dream part of the sleep cycle or to low levels of serotonin, a brain chemical that regulates sleep and pain perception. Other theories have linked fibromyalgia to low levels of somatomedin C, a chemical related to muscle strength and muscle repair, or to high levels of substance P, a chemical that affects the threshold at which a person experiences pain. Still others have cited trauma, blood-flow abnormalities in the muscles, viral infections or other infections as possible triggers of fibromyalgia.

Fibromyalgia affects an estimated 3.4% of women and 0.5% of men in the United States, or 3 million to 6 million Americans. It most commonly affects women of childbearing age or older. In fact, some estimates suggest that more than 7% of women in their 70s have fibromyalgia. Many people with fibromyalgia also have psychiatric problems such as depression, anxiety or eating disorders, although the relationship between them remains unclear.
After reading about others' experiences with Cymbalta, I was very hesitant to try it. However, I got to a point where I was willing to do anything to feel 'normal' again. I started Cymbalta (30mg) about 3 months ago and I am SO glad I did. The first week was unpleasant -- I was close to stopping it, but my family encouraged me to give it a fair shot. By the second week things were better. Now (still on 30mg) the only side effects that remain are loss of appetite (causing weight loss), occasional vivid dreams, and some difficulty with orgasm. For me the benefits have been huge -- I am able to focus, more energy, no more racing thoughts, no more crying spells, and no more anxiety/panic. Everyone is different, but for me this has worked great!