People with fibromyalgia whose symptoms don’t respond well to current therapies will soon have a new drug option. In January 2009 the Food and Drug Administration, or FDA, approved milnacipran HCl (Savella) to help manage the pain and fatigue associated with this disorder.
Milnacipran becomes the third drug to be approved by the FDA for fibromyalgia. It is the first drug to be newly introduced into the United States specifically for use in fibromyalgia, says Daniel Clauw, MD, professor of medicine in the division of rheumatology at the University of Michigan in Ann Arbor.
In the studies that led to its approval, milnacipran was shown to be safe and effective in two phase-3 studies involving more than 2,000 people living with fibromyalgia. In the studies, dosages of 100 milligrams (mg) per day and 200 mg per day demonstrated significant improvements in pain, patient global assessment and physical function. The most common adverse reaction to the drug was nausea. Other common side effects were constipation, dry mouth, excessive sweating, hot flushes, hypertension, increased heart rate and palpitations, and vomiting.
Milnacipran belongs to a class of drugs called selective serotonin and norepinephrine reuptake inhibitors. Although it’s still not clear exactly how these drugs work, some researchers believe they may help to correct abnormalities in certain brain neurotransmitters may be central to this pain disorder.
“Savella has been approved as an antidepressant for some time in many countries, but not in the United States,” says Dr. Clauw who was hired by Cypress Biosciences (now the U.S. licensor of milnacipran) to identify a safe, existing drug that had a profile that should make it effective in fibromyalgia. Dr. Clauw is also a member of Arthritis Today’s medical advisory board.
While milnacipran has not been tested head to head with other antidepressants, Dr. Clauw says there is evidence to suggest it may be more effective against the symptoms associated with fibromyalgia than other antidepressants, including other selective serotonin and norepinephrine reuptake inhibitors.
“Many animal and other studies suggest this drug may have – relative to serotonin – more norepinephrine reuptake properties,” says Dr. Clauw. “Many scientists feel that norepinephrine may be a more important neurotransmitter to modulate in chronic pain states than serotonin.”
“Norepinephrine activity may also better able to relieve symptoms such as fatigue and memory difficulties,” he says. “We won't really know if these effects seen in animal studies really translate into better improvement in these symptoms until further testing is performed.”
But other experts believe caution is warranted for this and other fibromyalgia drugs.
“The problem with most treatments for fibromyalgia is that they tend to work well in the short term,” says Frederick Wolfe, MD, Director of the National Data Bank for Rheumatic Diseases in Wichita, Kan. “These drugs have not been shown to be effective in the long run.”
Savella Approved for Fibromyalgia
By Mary Anne Dunkin
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Taia Frohman
27 Aug 2010, 19:30
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| I have had fibro for 12 years as well as osteogenisis imperfecta and osteoporosis. I take pain killers, zoloft, wellbutrin, amitriptlyine. I had tried Cymbalta and was very nauseated. Finally, my rhemetologist put me on Savella. What a wonderful change. I have more energy and a feeling of well being, even though I still have to deal with the pain there is a remarkable difference in things that I do now and am able to do much more of my chores and activities. Ask your doctor about it.....it helps me greatly ! |
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Lauren
17 Aug 2010, 10:21
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| I have fibro and a bunch of other stuff. Would recommend water aerobics if you have a place near you. Really helps me. |
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joan
14 Aug 2010, 19:45
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| Reading the comments has helped me plead my case with insurance about covering Savella. After I took sample for a week and took prescription in it was not covered. I have tried Lyrica and Cymbalta and now use Lexapro. Have severe back issue(no surgery) plus fibro. Have gotten off my exercise pattern over the summer due to grandchildren and visits so am feeling really bad. Like to hear comments and encouragements! Prayers for us all. Joan in Alabama |
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Nancy
10 Jul 2010, 04:56
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| For Diane: How long have you been taking this medicine? |
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Jackie Fontes
06 Jul 2010, 11:00
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| I found it almost killed me--at the lowest dose--12.5mg. 3 months later I am still flushing and heart rate out of control. Thank God I have an exceptional Cardiologist! |
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Claudia
03 Jun 2010, 23:19
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| Thanks for your remarks about Savella. I hadn't heard of it.I have Fibro, severe arthritis in my thumb joints, and have lousy nights. I take EffexforXR, Vicodone, celebrex, and clonasapan(sp)but still have no relief from pain. I will do research on Savella and talk to my doctor about it. Thanks guy, all we can do is keep trying and hanging in there! |
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Ana Salcedo
03 Jun 2010, 14:59
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| Is there a generic for this drug? |
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Tonie
02 Jun 2010, 17:32
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| Michele: Are you still taking this med ? I have been on Cymbalta for 4 years and it has not really done anything. Helped at first, but now not so much. I am getting off it and then we are going to try this one. I have RA, OA, FMS, and vertigo. The pain and depression really get me because I still work full time and well, let's just say my workplace is not the ideal place for stress relief. I asked about Savella yesterday when I went in and told him I cant take it anymore I had read on here that you guys were having good results with it. SOmething has to work. So we are going to use this plus some other options and see what helps. In the meanitme Remember me in your prayers. That always works wonders. |
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Diane
26 May 2010, 12:35
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| I am 51 years old, I went through a really roough time in my 30's. I was
diagnosed with arthritis, bursitis, fibromyalgia,vertigo and diabeties,
with all those complications (high blood pressure,cholestrol, etc. in short
I was falling apart. I have tried about 10 diferent drugs from generic to
name brand stuff. My doctor told me the "Good News" his patients had with
Savella. YEA RIGHT!!!!! Well I'm a gluton for punishment. He gave me several trial packs. I started real slow and worked my way up to 100mg. AND HERE I AM WRITING TO TELL YOU HOW HAPPY I AM. I never have been enthused so much about a product that I want to write about it. No I am not 100% free of pain, but I have such improvement I am now moving and doing so much more than what I was trying to do.I actually feel human. Whoever reads this, please give it a shot. Afterall, all we can do is keep trying. |
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Louise
04 May 2010, 09:29
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| I have been on savella for several months and I take it in the morning and one in the night time. I also take cymbalta and the combination of both medications has helped me tremendiously. I was in so much pain and since taking both I have gotten much relief. My doctor called the company that makes both to see if it could take both medications and they said it would be fine as long as I get bloodwork done at least every three months. I can't tell you how much better I feel taking both. It helps my fibromyalgia and also my depression. I also take Voltarin for my arthritis and the combination of all really makes a difference in my quality of life. |
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maritza
04 May 2010, 09:29
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| i am currently taking savella and at this time i still not feeling any better i take 50mg in morninig and 50 at night i am in constant pain i cant sleep i used cymbolta also did work for a little then all have started again these medication are so expensive i dont have insurance and just dont know what else to do i hurt all the time its hard to get out off bed in the morning still what can i do these meds dont work on me |
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Michele Craig
08 Apr 2010, 18:32
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| I was part of the clinical trials for Savella, and I have to say, that this
medication saved my life. I had Lyme disease (treated and was then
diagnosed with fibromyalgia). Before I began taking the Savella, I was
taking a huge bag of medications. I was in constant pain, had reactions to
several antidepressants, and really felt life was not worth living anymore.
Pain medications didn't seem to work for as pain would break through and I
was so fatigued, couldn't think, and had to give up my teaching job. During the study, I took 200 mg of Savella, I now take Savella (100 mg a day in two doses), tramadol for pain, and ambien CR for sleep. The Savella definitely helps with the fatigue, depression and pain. On 200 mg. I found that it disturbed my sleep if I took it in the pm. In the summer, I can sometimes cut back to 50 mg. a day. I have been taking it for three years and it still seems to work. It is extremely expensive though, and I have had trouble getting my health insurance to approve it. I would probably take a higher dosage now if I didn't have to pay for it. |
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Connie Rosenbrock
16 Mar 2010, 13:22
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| I am currently taking Savella and I love it so far. i just started a trial of it last week. I have been diagnosed with Fibromyalgia a little over 2 years ago. I started my medication regimen with cymbalta and the was absolutely awful for the long term; it caused memory loss and no fatigue relief. Savella seems so far to relive my fatigue by 80% and got my memory back too. I'm bummed a bit to read in the article that its not effective for the long run; but time will tell! |
Good Luck and God Bless everyone of you!
Cheryl AZ