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FDA Gives Milnacipran Green Light for Fibromyalgia Treatment – Third to Be Approved, After Lyrica and Cymbalta

  [ 12 votes ]   [ 17 Comments ] • January 15, 2009

The drug milnacipran (to be marketed under the brand name Savella™) received FDA approval as a prescription treatment for symptoms of fibromyalgia (FM) on January 14, 2009 – and reportedly will be available in U.S. pharmacies by March.

Milnacipran – a selective serotonin and norepinephrine dual reuptake inhibitor (SSNRI) developed as an antidepressant – has been tested in multiple trials for ability to demonstrate concurrent improvement in FM pain, physical function, and overall impression of change (global assessment).

Trials Measured “Global” Symptom Status
Generally, more trial subjects taking milnacipran than subjects taking placebo reported “at least a 30% reduction in pain from baseline and also rated themselves as ‘very much improved’ or ‘much improved’ in the global assessment,” according to a release by the drug’s developer, Cypress Bioscience (San Diego), and Forest Labs (New York), which owns the rights to milnacipran in the U.S. and Canada.

Milnacipran “is the only product approved for the management of fibromyalgia that used this complete responder analysis as its primary endpoint,” observes Cypress Bioscience CEO Jay D. Kranzler, MD, PhD.

“The introduction of Savella is important because it is the first drug approved to treat the symptoms of fibromyalgia using a composite responder analysis,” notes fibromyalgia pain specialist and researcher Dr. Daniel Clauw, Professor of Anesthesiology and Medicine (Rheumatology) at the University of Michigan, Ann Arbor.

May Address “Abnormalities in Certain Brain Neurotransmitters”
“Although the exact mechanism by which Savella improves the symptoms of Fibromyalgia is unknown, some researchers believe that abnormalities in certain brain neurotransmitters may be central to fibromyalgia," the news release states. "Savella blocks the reuptake of both norepinephrine and serotonin, with greater selectivity for the inhibition of norepinephrine reuptake in vitro. This may be the mechanism by which Savella acts to improve the symptoms of fibromyalgia.”

As with all potent drugs, milnacipran is not without potential side effects and contra-indications, as detailed in the Cypress Bioscience/Forest Labs news release under “Important Safety Information.”

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Article Comments Post a Comment

Oh!!! WOW!!! Now there's three drugs......
Posted by: Earth
Jan 21, 2009
Sure. Come March, I'll make another expensive appointment with a doctor to go through the hoops to buy another FDA approved drug to try to abate my continuous, unbearable pain. Will this one leave me hyper-swollen like Lyrica? Or hyper-constipated like Cymbalta? These drugs, although cited for uses against the ravages of fibromyalgia, seem to be more effective in consideration of the fiscal bottom-line of the pharmaceutical manufacturers. Give me a break! The most recent data released from the CDC indicates that survivors of childhood abuse are six (6) times more likely to experience myalgic encephalmylitis (that's chronic fatigue syndrome to all the victim-haters!)yet the pharmaceutical salesmen are still pushing ssri's. These may be great for depression, but chronic fatigue & fibro are NOT depression. How long will it take for the Ph.D.s and clinicians and the rest of the medical community to grasp that & to finally get around to developing something effective for the PAIN? Let's switch roles & have the MDs suffer the life crises casued by ME & fibro, and let me tell them , "Well, we have this drug that's supposed to work for you, but we really don't know how, but the government's given permission to peddle it to you. So, be a compliant, non-thinking, "good" patient & spend your last few dollars on something which may or may not be effective/damaging." That would be fun for a change. Can I get any MD's willing to play?
Reply Reply

I know exactly what you are saying
Posted by: octobermarriage
Jan 22, 2009
I too tried the Lyrica with no avail. I refused the Cymbalta due to the terrible side effects that I had read about the medication. I too feel like a pharmaceutical guinea pig. Spending a small fortune on meds per year; I am not willing to be part of pharmaceutical band wagon for the flavor of the year. I feel like this disease is a curse that I will endure for the rest of my life with no relief in sight.


Posted by: erbssr
Jan 25, 2009
I'm not a doctor & my wife is a Fibro sufferer. But, believe it or not, I think I know the answer to why some people sufferer from Fibro, although I wish I knew the cure. I have know my wife since she was 12 years old and she has always been sensitive to ANY pain. If you walked by and slapped her arm she would holler "Ow, that hurts!" when most people would have barely felt the tap. My belief is that for some reason, Fibro sufferers are basically people who have a very low(abnormal) tolerance for pain............period. Why? I don't know but it must be hard wired in their neuro system somehow that their pain sensation mechanism is overactive.If the Md's would figure out how to calm that system, I think we would have the answers & results we are all looking for.


Another drug...
Posted by: Suzan
Jan 21, 2009
I agree with the first poster! Another anti depressant that the drug company convinced the FDA is 'helpful to some' people with FM. Give me a break. Lyrica gave me every side effect that is mentioned. Cymbalta, did not help at all and was very difficult to stop! I know 'they' don't know what causes this..and that has as much to do as anything about why there is no definate medical path for helping us. But to just allow the drug companies to do trials that really have little real success....30% is hardly earth shattering success in my opinion....and then the insurance companies jump on board and nearly 'require' us to take these drugs to prove we do have this illness...and the doctors, because they don't have more to offer...write prescriptions for them at our request...because it is truly all they can do other than say, exercise, eat well, etc. etc. etc. The advice they give to everyone! I am ok with the medical community saying 'we don't know'...but don't treat me like a medical guinea pig because you don't have an answer to my illness.
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Posted by: igarfy
Jan 21, 2009
I totally agree with the other two. I suffer so bad every day as does all my fibro buddies. I have taken all the drugs out there with really bad side effects. I am still slowly weaning off of Cymbalta to escape the brain jags. I refuse to go on any other drugs. the side effects are almost as bad as fibro.
Reply Reply

new drug
Posted by: happyhour
Jan 21, 2009
I haven't used either of the drugs for fybro because of the side affects. It would be great if this one doesn't have any or at least not bad ones. I couldn't stand to gain 25 lbs., not that I am extremly over weight, like a couple of people I know that takes Lyrica. Because I have bad knees and my hands are already swollen to where I have had to have some of my rings made bigger. Sandi
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I will take
Posted by: schaken
Jan 21, 2009
I participated in this drug study several years ago. I went from hardly being able to walk and getting ready to file disability to walking (almostlike normal) and holding a full time job. Yes I had sde effects. I gained 10 lbs and sweated but it was worth it to be pain free and be able to sleep and move.
Reply Reply

Cymbalta saved my life!
Posted by: fnx3
Jan 22, 2009
As per another poster - I had just applied for Disability when I was put on Cymbalta. One week later when I went in for the assessment I was already markedly improved. Now after only 7 weeks I feel absolutely NORMAL for the first time in 18 months of pure hell. I have experienced NO side effects fr Cymbalta - not like all the other anti-depressants I had been tried on over the past 15 years. As for putting on weight I soon realised that this may be due to the fact that my whole body metabolism had slowed down, relaxed in fact! And that I just needed to learn to eat less & exercise more & now the weight is starting to shift.
Reply Reply

Side Effects
Posted by: budgirl1949
Jan 22, 2009
I am already on an antidepressant and that has held me back from trying some of the newer drugs. That plus so many side effects listed for them. I feel badly enough now, so why do I want to take a chance of feeling worse or getting rid of some symptoms only to add new ones? I do realize that any medication lists side effects..the question to everyone with an illness where a new med is discovered, are you willing to take the risk? Fibro is a very complicated disease that effects different people in so many different ways. No one pill can take care of all of them. I'm just happy that there are researchers out there that are trying to find an answer. Tess
Reply Reply

More Drugs?
Posted by: DF1344
Jan 23, 2009
I must say I agree with a lot of the comments about the new drugs for Fibro, especially the negative comments. It makes me mad to see that the drug companies still have the "treat the symptoms" mentality! I can say from my experience with this "God awful" Fibromyalgia, is that the nervous system is involved BUT IT IS NOT THE PROBLEM. These nervous system medicines hide the symptoms, but DO NOT CORRECT THE PROBLEM. And this is bad becuase it is helping you to cause more harm because you are NOT FEELING THE PAIN, but the problem is still there! So when the drugs finally do not work anymore, or you have to go off them because of side effects, you will have suffering beyond all imagination. When I finally had to go off the Meds, my feet, legs, knees and thighs hurt, burned, and were vibrating so badly that I thought I was going to drop dead. The drug manufacturers have to really start digging into ways to CORRECT BODY FUNCTION, and stop inventing new ways to hide pain. From my experience dealing with this affliction, it is my opinion that there is an immune system problem (either underactive or sometimes overactive), problems with microcirculation, as well as many other things that you will find posted at this web site. Isn't it strange that most doctors wil not do a cytokine profile on patients with these conditions? What is going on with the medical community? Please, HELP US AND STOP TRYING TO HIDE SYMPTOMS! My heart goes out to everyone dealing with this. Sincerely, DF1344, (AKA) "the guy that spent 20 years in the gym, and then became barely able to walk with an illness that doctors say is nothing".
Reply Reply

Posted by: erbssr
Jan 25, 2009
Not a doctor but I think Fibro is caused by some mechanism in the neuro system & that most, if not all, Fibro sufferers have abnormal sensitivity to pain.
Reply Reply

Posted by: erbssr
Jan 25, 2009
I should go further to say that my wife, whom I have known since she was 12 tears old, has always been sensitive to pain.If you were to pass by & slap her on the arm, she would over-react to the level of pain. This was years before she developed Fibro, which she has had for over 30 years.


central pain syndrome
Posted by: akimbo
Feb 7, 2009
I hear you about your antidepressant concerns however FMS is a brain-mediated pain syndrome so it does make sense to take neurological medications. Depression is present in FMS even though it is secondary. I've had FMS for 14 years. Have been taking Lyrica for 2 years but it has caused some weight gain and blurred vision and blurred thinking. I resisted the whole antidepressant route, but I caved in and started taking Paxil a month ago when I 'hit bottom'. Now I am sleeping better, and I'm way less anxious and have been able to proceed with some dietary modifications. My muscles are noticeable less stiff and my thinking is clearer. Most doctors are ill informed but please don't jump to the conclusion that if your doctor wants you to try antidepressant therapy that its solely because they think you are depressed. It may take some experimentation but it's worth a try (and antidepressants are relatively cheap).


Another Drug
Posted by: ksmabba
Jan 26, 2009
I agree with the majority of posters here re the previous fibro drugs. Cymbalta made me suicidal and as someone pointed out, depression may be a co-morbid issue but it isn't what fibro is all about anyway. Lyrica packed on the pounds and since I have lipidema/lymphedema that makes its use unteneble. I am now on disability for this disease (along with myalgic encephelomyelitis - aka chronic fatigue syndrome). I must disagree with erbssr re the pain. I have heard it said many times that we have a glitch giving us a lower sensitivity for pain and yet ironically, I am well-known for having an unusually high pain threshold. True, I may be the exception that proves the rule but I tend to believe that it is something about the pain itself that is unique as the fibro pain can reduce me to desperation and a fear that I just won't be able to find my way through it.
Reply Reply

Posted by: scottyojai
Jan 28, 2009
I've been disabled with Fibro/cfs/mcs/ibs, etc, for 15 years and have tried Cymbalta, Lyrica and Milnacipran. Every one of them made me worse. I'm beginning to think that the drug companys are using Fibromyalgia as a "catch-all" dumping ground for any new drug that they can even remotely attach to Fibromyalgia. It's all about the money folks. I have seven doctors and not one of them has a clue. Sorry to be so discouraging, but this is a very serious illness, without a cure. My wife also has it, and has had it longer than me. Together we've spent over $100,000 dollars on every drug, doctor, and phony cures, acupuncture, herbs, yoga and a hundred others....and here i am sitting on the sofa unable to even go for a walk. By the way, Milnacipran isn't new. i tried it years ago when it was called "IXEL" and i had to import it from Germany. An upside (or downside) to Milnacipran is that it can cause spontaneous ejaculation in men, though without orgasm. Anytime, anywhere. Bummer.
Reply Reply

New Fibromyalgia
Posted by: pearls
Feb 16, 2009
You have to learn to crawl before you can walk. Doctors don't yet know all the answers for fibromyalgia, but must treat the symptoms. So what else is new? Personally, I've had great success with Lyrica. My sleep has improved very much, as long as I also take my sleep meds and keep my life on an even keel. I have to work hard at it, and sometimes things just happen, like a death in the family that throws my schedule off whack. Lyrica has also made a big difference in my pain levels - from needing about four Vicodin daily to only needing maybe one weekly on average. If the drug only masks the problem, that's the way it is. I'm hoping the problem becomes better understood soon, but meanwhile I'm happy to have something that works for me. I do hope that one of these drugs will be the answer for more people with this disease.
Reply Reply

Us too
Posted by: willruthie1965
Jul 19, 2009
Hey My hubby and I both are sick from fybro also. How do u deal with it? We have no support from family. They make fun of us and call us lazy and cheat.My hubby gets ssd and I am waiting to win my case. I am feeling like I dont want to go on. Wht is the point? To be made fun of? I almost don't want to live in a world where your own family will make fun of you and call you fake! I wish we lived in a little community where everyone have fybro, Then maybe you would have loving people around you. So look foward to hearing from you. RJ
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