Anybody tried milnacipran yet?

Discussion in 'Fibromyalgia Main Forum' started by WillieCash, Mar 25, 2009.

  1. WillieCash

    WillieCash New Member

    Supposedly available in March 2009.

    Clinical trials show reduction in symptoms by 30%, which isn't great, but maybe they are at least on the right road.

    I know we've all heard it all before but I figure a litte bit of hope is never bad. Especially if they are starting to attack how the brain enzymes that don't release the pain signals as the source.

    There may be something we see before we all croak yet.

    Here's the article I found after my wife's Fibro doctor mentioned he was looking into it:

    FDA Approves Milnacipran for Fibromyalgia CME
    News Author: Susan Jeffrey
    CME Author: Laurie Barclay, MD

    Release Date: January 22, 2009

    January 22, 2009 — Forest Laboratories and Cypress Bioscience announced January 14 that the Food and Drug Administration (FDA) has approved milnacipran (Savella), a dual serotonin- and norepinephrine-reuptake inhibitor (SNRI), for the management of fibromyalgia.
    Efficacy of the drug was established in 2 pivotal US phase 3 trials, the companies note in a press statement. Treatment with 100-mg/day and 200-mg/day doses demonstrated "statistically significant and clinically meaningful" concurrent improvements in pain, patient global assessment, and physical function, the statement adds.

    The companies expect the drug to be available in pharmacies by March 2009.

    Fibromyalgia, characterized by widespread pain and decreased physical function, affects as many as 6 million people in the United States, according to estimates from the American College of Rheumatology, the statement notes.

    Although the exact mechanism of the benefit of milnacipran in this setting is not known, "some researchers believe that abnormalities in certain brain neurotransmitters may be central to fibromyalgia," the release states. Milnacipran blocks reuptake of serotonin and norepinephrine, with greater selectivity for norepinephrine in vitro. "This may be the mechanism by which [milnacipran] acts to improve the symptoms of fibromyalgia."

    Phase 3 Trials

    Data to support this indication were taken from two phase 3 trials that used a "composite responder analysis," the statement states. "This end point required individual patients to demonstrate concurrent improvement to multiple validated measures, including pain (visual analog scale), patient global assessment (patient global impression of change), and physical function (Short Form-36 Physical Component Summary)," the companies note.

    The phase 3 trials, 6 months and 3 months in duration, respectively, included 2084 patients: 1460 treated with milnacipran and 624 with placebo. In both studies, a greater proportion of patients treated with 100 or 200 mg/day of milnacipran had at least a 30% reduction in pain from baseline and rated themselves as "very much improved" or "much improved" on the patient global assessment. More treated patients also met criteria for treatment response by concurrent improvements in pain, physical function, and patient global assessment.

    The treatment was safe and generally well tolerated. The most frequently occurring adverse reaction was nausea; other common reactions included constipation, hot flush, hyperhidrosis, vomiting, palpitations, increased heart rate, dry mouth, and hypertension. The majority of these reactions were mild to moderate in nature, the statement adds.


    As an SNRI, milnacipran is similar to other drugs used for the treatment of depression and other psychiatric disorders, the statement points out. Antidepressants cause increased thoughts of suicidality in children, adolescents, and young adults compared with placebo. Although it is not approved for major depressive disorder or in pediatric patients, "patients of all ages who are started on [milnacipran] should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior," the press release states. "Families and caregivers should be advised of the need for close observation and communication with the prescriber."

    A variety of other contraindications are noted in the release. The drug should not be taken concomitantly with monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuing an MAOI. Development of potentially life-threatening serotonin syndrome can occur with drugs that, like milnacipran, inhibit serotonin reuptake, particularly with concomitant use of serotonergic drugs such as triptans or tramadol or with drugs that impair metabolism of serotonin such as MAOIs. Concomitant use with serotonin precursors is also not recommended.

    Blood pressure and heart rate should be monitored prior to initiating treatment and periodically during treatment, as SNRIs, including milnacipran, have been shown to increase blood pressure and heart rate. Preexisting hypertension, tachyarrhythmias, and other cardiac diseases should be treated before use of the drug, the release notes, and it should be used with caution in patients with significant hypertension or cardiac disease. For those who experience a sustained increase in blood pressure or heart rate on treatment, either dose reduction or discontinuation should be considered, the release states. Gradual reductions in dose are recommended, as withdrawal symptoms have been observed following discontinuation of milnacipran.

    Mild elevations in liver enzymes have also been observed with treatment and, rarely, fulminant hepatitis, the statement adds. It also increases bleeding risk, and patients should be cautioned about concomitant use of milnacipran and nonsteroidal anti-inflammatory drugs, aspirin, warfarin, or other drugs that affect coagulation.

    Milnacipran should be prescribed "with caution" in patients with a history of seizure disorder, mania, or controlled narrow-angle glaucoma and should "ordinarily not be prescribed" in patients with substantial alcohol use or evidence of chronic liver disease, the statement adds.

    Savella Prescribing Information

    Pearls for Practice
    Milnacipran at dosages of 100 and 200 mg/day for the management of fibromyalgia was associated with reduction in pain and improvements in patient global assessment and physical function.
    Treatment with milnacipran was safe and generally well tolerated, with nausea being the most often reported adverse effect.

    [This Message was Edited on 03/25/2009]
  2. WillieCash

    WillieCash New Member

    Just bumping becuase this could be good news. No one is using though, huh?
  3. texasrose204

    texasrose204 New Member

    he said yes he knew about it and to call him back end of the month which will be next week. I am hoping he starts me on it and hoping it helps! It would be nice to hear from anyone that has tried it!
  4. WillieCash

    WillieCash New Member

    Has anybody else tried it?
  5. satchya

    satchya New Member

    Tramadol also works as a SNRI, it's short-acting, so you have to take it several times a day instead of once, but that is why withdrawal from it can be such a bear, because it causes SNRI or SSRI type withdrawal, not just opiate-type withdrawal.

    I have had a lot of help from Tramadol, though the pain lessening effect has gradually decreased over the three years I've been taking it, but it made a huge difference in my depression (which I believe now was caused by the same low serotonin and norepinephrine that contributes to fibromyalgia).

    It's certainly worth a try if you aren't happy with what you're already taking!
  6. lynncats

    lynncats New Member

    I go back to my rheumy Apr. 20th. She stated back in Feb. that she will consider milnacipran in April. So we shall see, and I'll keep in touch.
  7. acdb

    acdb Member

    My doc wants to try me on it when he can get it. The drug seems similar to Welbutrin, which I have been taking forever for depression. I'm on Lyrica now, which has gotten me out of chronic horrible pain. It does not help with fatigue and I don't like some of the side effects.

    So, not sure if I will try Savella. Tired of playing with meds.
    I'd like to know how others do on it too.
  8. AuntTammie

    AuntTammie New Member

    wellbutrin acts on dopamine and norepinepherine, while milnacipran acts on serotonin and norepinepherine, so they are not the same.....I know what you mean about being tired of playing with meds, though....I went thru a ton of different ones before deciding that meds are just not a good idea for me...also, does your doc want to keep you on the two that you are on and add milnacipran, because if so, that would seem to potentially make your levels of norepinepherine excessively high....considering that norepinepherine is related to epinepherine (a precursor, I think), and epinepherine is another name for adrenaline, I would be a little concerned about that (people with our illnesses tend to have adrenal issues, and I'm not sure if playing around with that too much is a good idea, or not...there is a possibility it could actually be helpful, but I would tend to think not)
  9. HanginginNYC

    HanginginNYC New Member

    Has anyone really tried it? I am anxious to hear from others, as I would like to ask my rheumatologist about Milnacipran at the next visit. I am currently taking Tramadol up to five times each day. Either the pain has gotten worse this year or the medication is beginning to stop working. It works better than taking nothing at all, but would like to try this new medication.
  10. lynncats

    lynncats New Member

    she says it won't be available until June, but first it was April. I've heard this since Feb., so how does one try it????
  11. hensue

    hensue New Member

    I have sent a message out to her but she has not responded. I think it was the 12th she started i am not sure. It is Savella or the old drug milnacprin.
    Check her out, I am anxious to know if she has improved. I hope since she has not been on the board she is sick.

    Hopefully she is out doing jumping jacks or swimming who knows.
    Lets pray
  12. hensue

    hensue New Member

    I have sent a message out to her but she has not responded. I think it was the 12th she started i am not sure. It is Savella or the old drug milnacprin.
    Check her out, I am anxious to know if she has improved. I hope since she has not been on the board she is sick.

    Hopefully she is out doing jumping jacks or swimming who knows.
    Lets pray
  13. cathugs

    cathugs New Member

    Hi, I am here. I started on Savella on Monday.I am on the tritation sample.
    I started out on 121/2 mg for 3 days. I started on the 25 mg. this morn.
    I will take it twice a day til Monday. Then I'll do 50 mg. twice a day for a week. Then I will let the Rheumy know if it is helping. If it is he will
    write me a Rx. for it.

    So far the only thing I have noticed is a touch of nausea which is
    one of the side affects. This has not been bad, just a little noticeable.

    I have noticed today that I have not hurt in my ribs and chest
    as much as usual. We'll see how it goes in the next few days.

    So far I feel encouraged. And.. One of the side affects is..........
    WEIGHT LOSS!!!.Boy I can surely use that.

    My Dr. just got his samples in last week. He seemed really excited
    to have me try it. He has tried me on a lot of things in the last
    11 years. I tried Lyrica but it was a no-no for me. I gained 12 lbs. in 6 weeks and my feet and legs swelled so bad that I almost had cellulitis.

    I have OA in all my major joints and have had total joint replacement
    in both knees and left shoulder. S when I hurt I "REALLY" hurt.

    I take hydrocodone, clonazepam, zanaflex,and meloxicam
    for pain and sleep. Then I am on HBP meds, fluid pills and
    prilosec to keep other med from killing my stomach.

    I am hoping that maybe I can drop some of the other meds
    after I get the Savella in my system good.

    I will keep posting along to let you know how things are going,
    and if any one has questions I will be glad to answer if I can.

    Wish me luck folks, I have had this mess for years. Hopefully,
    since this med was made just for Fibro that it will help some
    of our suffering.

    May God Bless. (((((((((((((cathugs)))))))))))))
  14. timespent

    timespent New Member

    The nausea steadily worsened at the beginning, but I hung in and it was well worth it. It was so bad that I took anti-nausea medicine. It DID go away and I don't need to take anything for nausea now. I've been on the max dose for a couple of years and I was one of the first to enter the long-term study. So far, the study is ongoing, which is terrific for me because they provide the meds. I was really struggling with pain and fatigue. I still have bouts of being really worn out and achy, but nothing like I was at the beginning. I have a lot of good days now and the med is terrific. So...hang in there!
  15. timespent

    timespent New Member

    I've had great results with milnacipran. The down side was the nausea that lasted several months....but it DID go away and I haven't had to take anything for nausea in a long long time. Definitely give it a try. I took an anti-nausea med, which helped to get me thru it. I've been taking the max dose for a couple of years now.
  16. cathugs

    cathugs New Member

    Hi,timespent. I have been on Savella for several weeks now.
    Like you I had a little problem with nausea, but not enough to stop me from taking it.

    I am no on 50mg twice a day. What is the maximum dosage?
    I did the 2 week trial pack and then the first months rx. I just started on my second month today. I saw my rheumy yesterday. He wants to wait a couple of months before he raises the dosage.

    Have you lost any weight on it? I was glad to see one of the side
    affects was weight loss. I have lost 7 lbs since I have been on it.
    I hope I keep losing for a while. About every thing before that I have
    taken has caused weight gain.

    Lyrica really did a number on me with excessive swelling and weight gain.
    My nausea has not been bad enough to take anything for it.
    What has it helped you with the most? I just feel better all over. I don't feel as weak and tired as I did. The pain in my ribs and back is a lot better.

    I can tolerate the pain better than I can the never ending fatigue.
    Will you keep posting to let us know how you are doing?
    I am very interested since you have been on it long term and I am a newbie at this.
    I am sure more of the posters will be interested since several of started around the same time.

    cathugs (ruth)
  17. momof3inks

    momof3inks New Member

    I wanted to try this drug but my doctor said since i didn't respond to Lyrica very well, that I would not do well on it. bummer... I'm anxious to know more about it though. I agree with whoever said they were using Tramadol. I love that stuff! but it is interacting with the Cymbalta I am taking. And for what it's worth, Cymbalta is not doing anything for me. I'm on my third month and have no relief. I'm going to give it a few more weeks and then I'm done trying different meds.

  18. cathugs

    cathugs New Member

    I could not take Lyrica at all. My feet and legs swelled so bad that I had to go to the dr. when I was on it. Also I gained a lot of weight in no time. It did not help me at all.

    The Savella is a different story altogether. I have been on it about 7 weeks. I can tell a lot of difference in the way I feel. I don't feel as fatigued as I did and I am in a lot less pain. Also I am not swelling.
    As a matter of fact I have lost 9 lbs. since I have been on it.

    I have had some nausea, but not enough to even take any thing for it.
    If I were you and really wanted to try it I would ask her to reconsider
    rxing it. You know what helps some of us doesn't do any thing for others.

    I have tried so many things that didn't help that I was sort of a skeptic about trying the Savella, but I am glad that I did.

    I would like to know what the maximum dosage is. Does any one know. I am taking 50mg twice a day, so far. He wants to wait a couple of months to increase the dosage because of the nausea.

    My husband even told me he could tell the Savella was helping. I asked him how he could tell. He said I was not dragging around like I was half dead like i usually did. LOL. And I didn't think he even noticed that I was half dead. lol.

  19. AuntTammie

    AuntTammie New Member

    I'm a little confused...or rather, it sounds like your Dr is confused, bc Lyrica and Savella are two very different meds, but savella and cymbalta are very you respond to lyrica should have nothing to do with how you respond to savella; however, how you respond (or fail to do so, as you said) to cymbalta would be much more likely to indicate how you might respond to savella
  20. maury

    maury New Member

    Glad to hear some results from people taking this drug. My doctor gave me the month sample packet to try. However, I have been on Effexor for a number of years and am concerned about going off of it. He told me how to step down, as I step up the Savella. Also, I just started taking a BP medication and I read where Savella can increase BP. So, I am a little nervous about starting it.

    If and when I do take it, I will share my experience :)