1/14/09 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


































I'm ready to call it quits, both with Savella and life. Is there anyone out there who can help someone like me end it all. I can't go on any more. The pain, the bankruptcy, the loneliness, that are caused by these pernicious diseases are killing me. Is there a doctor that can administer a lethal dose of something? Do I need to kill someone so the state can legally execute me? PLEASE HELP!!!!!
I have had fibromyalgia since the late 70's early 80's. I have had the whole trip with fibromyalgis, been insulted by a myriad of doctors who wouldn't have a cup of coffee with me or you, taken every drug possible:zoloft seratonin, paxil,tramadol, amatriptaline, methadone,effexor, cymbalta,neuronton, and currently hydrocodone. I am still in pain, numbness crawls all over me, even my face, fibro fog, memory loss, loss of balance, insomnia, restless leg syndrom that is unbelieveable. I even have sever muscle jerking in my core muscles that punch me from within. Even though every doctor I see tells me that I have the sorst fibro they have ever seen they soon tire of treating me. I have gone from a young vital woman in my 30's to an old woman with this disease. Faith in God has been my main stay and kept me from suicide. I have wanted to die so badly at times to excape the pain, but my Christian beliefs kept me from doing so. I pray. I pray for God to develop the good things within me that He wants to see. He has pulled me out of the depths and mentally I am doing better and keep plugging on. I keep busy with jewelry making, water color, and Chinese ink drawing, and sewing. Staying busy takes me away from the consciousness of the pain. I think they call that transcending pain. Ha! what difference does that make. Fancy word. Warm water, my heating pad and sombra lotion are my helpers. God is constantly my companion and confidant. My little dog, Giz, is a blessing, and my husband has really hung in there with me even though I am sure at times he would have loved to have run.
Longevity runs in my family. My grandmother lived to be 98, and many of my aunts are in their 90's. I try not to look at the future because of this, because I can't stand the thought of living another thirty or so years with this disease, but I will if I have to. I believe that God will make me able to do so. Even though talking about fibromyalgia is depressing I want to give all of you hope. None of know what good thing can happen tomorrow. Maybe a cure. Maybe a new friend. Maybe the why of it all explained.
Things that I am personally interested is reversing muscle memory, microcurrent therapy, and new medications whose side effects aren't worse that the disease. I am open to good results, and am living today the very best that I can. That's all that I can do.
My love, empathy, and companion to all of you who are suffering fibromyalgia. I truly care about all of you, and hope for a better, painless tomorrow for all of us. Ami
Go to a new one. A lot of Chiropractic offices are now working in tandem with Acupuncturists and Massage Therapists (no I don't mean the Swedish massage types either). When I lost my massage therapis is when I started going downhill. I haven't found a replacement yet and the slide is a slippery one in that it is affecting my work now too.
My thoughts and prayers are with all of you. Keep plugging away, hugs & good luck!!
I am very interested in utilizing a non-drug approach and have already incorporated a healthy diet, exercise daily and stress reducing mechanisms. I have constant fatique and wake up exhausted everyday. My muscles aches increase with stress and are mostly in my legs.
Thanks,
SS
OMG I am so sorry you had to suffer like that. Ask your general practitioner for Savella. Realize that while you cannot stop that place from existing, you can take a stand. Do it online.
I understand the way you were feeling. I have probably a dozen different prescps I have to take for this and that, that are working against me with Fibro & Osteoarthritis. I have Meniere's - am losing my hearing - have a Thyroid problem, just had 16 inches of my colon removed last fall.
Keep the faith all. It won't take away your pain, but it will help you continue to be you.
They are threatening to foreclose on my house because of the surgery last year - I had to be out of work for 4 months - so faith is just about all that is sustaining my husband and me right now. We can't afford to always buy the freshest / get all of the massages / acupuncture / etc. BUT - my pain meds are affordable right now.
I am 51 years old this year and i hurt. Does anyone have a problem with their feet? First, my toes are numb to the balls of my feet. The sides of my feet are numb too. The arch and heel of my feet are in a constant state of extreme pain. I don't know what to do.
Good luck to everyone JJ
Thank You,
Jill Bowman
Thanks for the Info
Cathy
I am currenly on a regime of Tramadol and Cymbalta. I have tried Lyrica, Vicodin, Darvocet, NSAIDs, Flexeril, Prozac, Wellbutrin, Paxil, Amitryptaline, Nortryptaline, and I can't remember what else!
I have been on the current regime for the past year. It definitely helps. Without it, I could not get up at all. With it, I am able to get up after about three hours of gentle stretching and mental excercise. I am a single parent of three children, so giving in to this illness is simply not an option. In the meantime, though, I developed OA. . .but am now wondering if I may have RA. I have symptoms of Sjorens Syndrome, and Thyroid issues. Having FMS for so long, it is difficult to get my doctors to look past this diagnosis at the newer symptoms I am experiencing (the joints in my hands, wrists and feet are especially stiff-swollen and painful now). My other joints are stiff, crackly and hurt - but I think that is probably the OA. With the grace of God, and Affirmative Action, I am able to maintain employment on a modified schedule (I come in 10:00 a.m. ish instead of 8:00 a.m.). I am sooooo blessed that this has worked out for me. Every day is a challenge to get up and get movin - but I have my three little kiddos to inspire me. I thank God each and every day I make it to a standing position and make it to work (conveniently located 30 seconds from home- and at the school where my children attend).
It is HARD - but giving up is simply not an option! The most challenging part is getting people to understand that what I experience is REAL, and that I am not lazy or apathetic. I honestly do the best I can. I don't know how much longer my co-workers will tolerate my schedule, but until then, I try to make the most of each and every day. Empathy (not sympathy) does wonders. Generally, I feel better when I get to work. Without it, I think I would be too inclined to give in to the pain and fatigue and immobilize.
I am too stubborn to give up- I research and pray, and try to remain positive. I don't want my children to develop sympathy pains or a "woe is me" attitude!
I've also tried B12 injections (and sublingual) for energy - unfortunately rely on caffeine to help boost me in the morning (I know, I know - I've TRIED going without it - but no improvement). Of course diet is really important, and even mild exercise. I stretch a lot. My body looks and feels like a workout 24/7 because my muscles are so hard. The reality is that my muscles are always sooooo tight and injure easily.
Also, I TRY not to be totaly self-absorbed. . that is, focus on the needs of others. I can't do much, but sometimes just offering a smile, compliment, or an ear - can be of service to others.
By focusing more on making other people smile and less on feeling sorry for myself, I think I've managed to make the best of a bad situation. . . at least as of the moment ;-)
When I exercise I feel so much worse I do some every day hoping it will help.
I have to say when I first was diagnosed with FMS, it was mostly in my arms and back. I really thought I had bone cancer. I now have it through out my body. I don't sleep well my memory is getting bad,depression is always there. I have tried cymbalta, lyrica didnt have much relief and didnt like how I felt.I tried Savella a while ago had some relief then very little.I am on Opana which is a long term pain relever and percocet for break through, and Cymbalta . Most days It is tollerble other days I don't want to do this any more. If anyone has some better answers or help please give us all some answers. I'm way to young too young as I am sure alot of you are. Thanks for any ideas. Going to try Yoga and Ti chia. Kathy AZ
Good Luck and God Bless everyone of you!
Cheryl AZ
How long have you been taking this medicine?
3 months later I am still flushing and heart rate out of control.
Thank God I have an exceptional Cardiologist!
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.
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.
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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