People with fibromyalgia whose symptoms don’t respond well to current therapies will soon have a new drug option. Last week, 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.”
New Drug Approved for Fibromyalgia
By Mary Anne Dunkin
Christine 19 Nov 2009, 09:26 |
| Carla, this is the same thing's I am going through and your right, if we were addicts and drinkers that put us into this mess we would have no problem gettin ssd. However I have been put on Savella my Dr. gave me 4 months of samples to try as I do not have insurance and I'm unemployed. I live off of $600 a month and cant work everytime I start a job I call in and they wont' put up with that. I have been denied Unemployment because my old boss is being a B!%#@! I really don't know what else to do and I'm still waiting for SS to give me an answer. I tried my hardest to work but even though I have been on Savella the last 2 month I'm still taking Xanex, flexeral, and or Loratabs for the pain. I feel it's not working along with my Migraine's once a week and the back pain, I feel so worthless. My kids do most all the chores and it's so unfair to them to have to take care of their mother. I wish you luck and if I find any help for you I will post it. God Bless and Good Luck. |
carolyn shrewsbury 04 Nov 2009, 07:57 |
| as you can tell from my e-mail address I am a nurse do you think this new
drug call Salleva will make restless legs worse? Many of these drug do sincerely carolyn |
Chat Lady 26 Oct 2009, 20:20 |
| Hello, After much time & sever pain I have now been diagnosed with firomyalgia. My doctor has recently put me on Savella. It is the only help I have got. I take it religiously each day as prescribed. Wish everyone painless & happy times! |
Terrye 05 Oct 2009, 19:06 |
| I wonder if Savella can be used with other SSRIs? Lyrica and Cymbalta did not help me, so I am eager to try this new med. |
Mom 18 Aug 2009, 22:20 |
| Ever try Xanax? |
Carla 15 Aug 2009, 05:57 |
| I have had fibro for 4 years now and severe depression (7) for the past two
years. I have been on Zoloft, Cymbalta, Lyrica, Paxil, Lexapro worked for
4.5 months and I had went back to work..it stopped working sadly. None of
the pain meds suggested for fibro have not worked either. I have no medical insurance and have been dependant on friends and family the last two years for a place to live. I have tried and been denied 2 times for SSI. I cannot go the the "doctors" and get the meds I want to try because of no state or federal programs cover me. I have worked since I was 13-14 years and payed into the system. I am so sick of being in the cracks of the system who dont care!!! Sadly if I was a drug addict or and alcholic or just got out of jail or prison or even an illigeal allien I would get a medical card...does this seem fair at all?? SSI judges dont care and do not pay attention to detail in some of their cases..I sat in the last hearing listening to 3 people discuss if I would be a loss of production or cost to an employer. They said I would not be a good canidate for any work and not employable. Yet I was denied because I was not following up on medical and my counceling....I have no funds or help to do this!!! There needs to be someone out there to stand up for us who need it badly!!! |
Cheryl H 04 Aug 2009, 10:21 |
| I took Cymbalta for about three months and didn't notice much difference in how I was feeling. As soon as Savella came out, my doctor put me on it. It is incredible!! I have been on it about 2-3 months now and I have only had 2 bad days the whole time. Fatique was a huge problem for me (almost daily) and it isn't happening now! Pain is almost all gone. I feel like a different person. Yeah Savella!!! |
deb 21 Jul 2009, 13:29 |
| I have heard really good things about Savella; unfortunately my insurance
will not approve this medication...yet. I was told by my fibro dr. that I
have to wait until the drug company, Cypress, puts Savella on the formulary
lists and then most insurance companies will approve since it is about the
same cost as Cymbalta. My dr. has stopped writing scrips for it until it
gets on the list as it seems all insurance is denying claims for Savella.
My sister also has fibro and her dr. gave her samples of Savella and the first week was a little rough as she had to taper off her prior med and slowly build up to correct daily dose of Savella...and she loves it! Says it controls the pain so much better and helps with clarity of thinking. I hate the "fibro fog" so I was really encouraged by her comments- and trust me, she is very critical of lots of drs and meds, so a positive "thumbs up" from her tells me I need to get on this med ASAP ! Hope this helps - have a blessed day! |
Anyes Daskal 14 Jul 2009, 13:07 |
| I need to know whether Savella (at least at the beginning of taking it) is compatible with Vicodin? Thank you for your answer. Anyes Daskal |
Sharon 14 Jul 2009, 00:49 |
| Caroline, I do sympathize with what you are going through. The pain gets so
old and sleep is the only release available, but most of the time you don't
sleep. I have had fiborcrap for 20 yrs. this summer. What seems to work
best for me lately is neurontin, I was on up to 4800 mgs. a day but my
current dr. cut that down to 2400 because of concerns over side effects.
(600 mgs 4 x day), cymbalta 60mg daily, methadone 10mg 4 x day. It takes a
long time to get used to the neurontin (staying awake) but after several
months I got to where I could stay awake. Honestly, sleeping all the time
was so much better than all the years of not sleeping. Alot of the
neck/headache pain proved to be migraines in spite of the fact I did not
have the usual migraine symptoms except for the horrible pain. It's all so
complicated and trying to find something that works even for a while is so
difficult. I am in no way out of pain but I am somewhat better right now.
I also get shots in my spine (either neck or lower back) every month.
Right now I'm so mad about the weight gain I could spit. Good luck. |
pauline 11 Jun 2009, 11:33 |
| I have found that the physical therepy has done wonders for me i wasnt able to walk up the basement stairs nor arround the block with my five year old son and i am only 33yrs old i have tried alot of medications and the shots of cortizone didnt work but the homothrepy does applying heat in the morning and evening and doing the physical therepy being on a routine getting proper sleep yes sometimes i have to use sleeping pills to get to sleep but not daily i am trying this new medicine savella and it has taken alot of the pain away and over half of my swelling but i do have some side affects like the nausia,edginess, dry mouth, and abnormal menstrual cycle so far but i am only on the third week so i am wondering if some of this will go away or not, and i am worried about the insurance covering this as of now my insurance company wont let me take out short term or long term disabilty cause of my fibro which really bites being a single mother with no other income coming in so god forbid if anything ever happened to me like broken legs or something i would loose my place to live as well cause i wouldnt be able to make it to work. |
mary Schlatt 09 Jun 2009, 11:22 |
| I just started Savella 2 days ago & was wondering if I could take vicodin
325/ 25 while using this drug. I had back sugery 2 years ago & still am still in a lot of pain. Thank you very much. |
Ruben 03 Jun 2009, 12:29 |
| My doctors have a problem finding what is wrong with me. My new doctors have not diagnosed me with anything yet. But they are treating me for fibromyalgia. I was seeing a doctor for five years who diagnosed me with RA after three years of seeing her. She was having trouble finding anything for me because it was not showing up in the blood test. My new doctors are treating me for something different. I have been on new drugs for a while. I don't want to list all the drugs. I am always scared of my lever giving up but I am young (31) and taking care of myself. However, today I am going to start the new drug savella. I hope that it works because I am tired of the pain. I fill that I can't alot of the things I use to be able to do. Walking, jogging, writing on the board, or even reading a book. We will find out how it works. I go back to the doctor in two weeks. I hope that I have good news to report to him. I better get off the computer because I am in alot of pain just being here. |
Caroline Mulvey 02 Jun 2009, 12:01 |
| I have been sick for 10 years. I have tried so many drugs they seem to run together.I have been going to my Rehumitologist (I forgot how to spell it). Any way, I go every other week and he gives me shots up and down my back, and my left hand. They stuff he uses is cortizone and ?. It freezes my pain for about 9 to 11 days. Sometimes I am in pain again 3 days later. I an on dillauid, percocet, tremadol, ultram, and about 10 more pills. I am not as "out of it" as I was. I am doing college online. I am sick of the pain!!!! I need some relief. I would be happy if one Sunday I could take a ride with my husband. Just for fun!! But going to the doctors every Thursday kills me for the weekend. I hate this!!! Why can't we get ant relief? What are the drug companies and the federal government doing for us? Well my pitty party needs to end. School and family await. Thanks for listening. Carol |
debbie 20 May 2009, 07:53 |
| I have been on Savella for 3 weeks now and it is amazing.No side effects so far.I sleep better with little pain or no pain.My insurance won't pay for it so I don't know what I am going to do since I can't afford 130.00 a month for one prescription. |
Cheryl 19 May 2009, 12:51 |
| My doctor just gave me samples of Savella yesterday, so it is now available. I have to wean off my Cymbalta for 2 weeks before starting it. so we'll see! |
Brandi 14 May 2009, 00:17 |
| I was finally diagnosed with fibromyalgia about a year ago. Have been in pain off and on for about 5 years now. I too have taken my fair share of antidepressents over the years though none have really worked. I am now taking Cymalta, Lyrica, Vitamin D, B12 shots 1-2 times a week, Tramadol and Elavil and really none of it takes the pain away. I have recently been told that I have carpel tunnel in both hands so for now I sleep with braces on both hands. So I really do not sleep much at all. Although my husband says I sleep all the time. I have recently started to try to find alternate ways of minimizing the pain and finding this web site has given me some ideas and some other meds to discuss with my doctor. I too am very excited about Savella and can't wait till it is available to us. |
Lisa 06 May 2009, 19:27 |
| Have any of you tried Tramadol for pain? This is the only pain medicine that I have found that works. I was diagnosed with Sever Fibromyalgia and moderate Rheumatoid Arthritis. I am not on any medicine for the Fibro. I take 2 tramadols 3 times a day. I also take one Flexeril before bedtime. I was told by the doctor to take it one hour before bedtime but I found I needed to take it several hours before to have it benefit my sleep. I also wake up many times a night and urinate most every time I wake up. I am on Arava for the RA. I also had very low levels of Vitamin D so I was put on prescription VD one a week for 8 weeks. I have a whirlpool bath with an in-line heater that I use to heat up my muscles. This helps my foot, knee, hip, shoulder, arm and hand pain. I have found this helps me sleep for longer periods at night. I also use Biofreeze spray and roll-on gel. I have a combination fiberbed/memory foam topper on my pillow top mattress. Even though my husband says it feels good to him, I still have pain and toss and turn all night. I sweat alot with exertion and am always hot in the bed - sleeping with no covers. Any responses with suggestions greatly appreciated. |
ESTHER 29 Apr 2009, 16:35 |
| I STARDED WITH PAIN ON 1999.AND JUST HIS YEAR I WAS DIAGNOSE WITH FIBROMYALGIA.AND SINCE THEN DOCTORS GAVE ALL KIND OF DRUGS ..FOR PAIN...AND THE WOULD NEVER GO ,,,KNOW I AMIN APIN STILL EVEN THOUGH DOCTOR HAS ME LYRICA,EHTOLAC,VICODIN,AND I HAD ZANZFLEX WHICH I HAD TO STOP BECAUSE I WAS FEELING WIERED SO I LET THE DOCTOR ,,KNOW SHE TOLD ME TO STOP IT AND THROW IT AWAY ...THEY ONCE GAVE CYMBALTA,,AND ON THE FIRST PILL I ENDED UP IN THE HOSPITAL W/ HIGH BLOOD PRSSURE,CHILLS,TRIMBLING AND NAUSEA IT FELT TERRIBLE I WAS SCARED EVEN MY HEART GOT OUT A LITTLE REACTION THE CYMBALTA SO,,,KNOW I LIVE WITH CONSTANLY PAIN I AM SO TIRED EVERY DAY MY JAW,NECK,SHOULDERS,UPPER BACK,MY HIP SEDS ,THIGHS ,STOMACH + I CARTLIDGE ON MY KNEES ARE WORN OUT I HAVE OSTEOARTHRTIS.ON KNEE ANKELS SHOULDERS HIPS AND BACK...I FEEL MY BODY IS GIVING UP ON EVEN THOUGH I DO LOTS OF THINGS AT HOME AFTER WORDS ITS JUST PAIN LOTS OF PAIN... |
Mirajoy 30 Mar 2009, 11:35 |
| I was diagnosed with fibromyalgia 15 years ago. The only meds. that have
helped me is melatonin for sleep and Amenda. This drug has not been approved for fibromyalgia and Insurance will not pay for it. The American Medical Field should do more research on this drug and try to get the FDA to approve it so The Insurance Companies will pay for this medicine to treat fibromyalgia. |
Terri Humphrey 27 Mar 2009, 19:17 |
| What is the main difference between Savella and Cymbalta? They are from the
same family both serotoin norepinephrine reuptake inhibitors. What would be
the benifit to trying the Savella, I am already on the Cymbalta without
alot of relief |
Kathy 25 Mar 2009, 19:59 |
| When will doctors do an in-depth medical health survey on all of their
patients they have with fibromyalgia and enter into a database to see if
there is some sort of mutual connection? I was first diagnosed with fibromyalgia in 1989. At first it was a mild attack, much like the flu, without the vomiting and diarrhea. I have since had to major attacks. One, in 1991 after having major surgery, a hysterectomy and suffering with a severe UTI that went untreated. The second attack was in the summer of 2004 and I was on Wellbutrin twice a day, along with a dose of Cymbalta, a dose of Sonata and a dose of Seroquel. NONE of these helped stop the pain or helped me sleep. The only thing they did was caused my hair to fall out. In the past 18 years, I have been on so many 'antidepressants' and NONE have helped. I was on Lyrica for 30 days and it did help until the doctors office didn't get the refill okayed in time for the pharmacy to fill the new prescription. I was off of Lyrica for 3 days. When I tried to go back on it, I didn't get any relief. I waited 4 or 5 months and tried it again, and no relief. I am in severe, chronic pain all the time with no relief. I have pain in the muscles and nerve endings in my shoulders, neck and the area between my waist and hips and suffer to the point of exhaustion, since it wakes me during the night with pain in my bladder and having to use the bathroom every 30 to 90 minutes. I so wish the American medical field would do some followup research done by French doctors who did MRI's on the brains of women with and without fibromyalgia and their findings showed an increased blood flow to the area of the brain that senses pain. This may be a neurological problem as well as a hormonal problem. I have had 3 of my 4 adult children also diagnosed with fibromyalgia so it must be hereditary. |
