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
I wanted to share w/ya THT do do have insurance or THT have issues of a Med not being covered. GO TO THE PHARMACEUDICAL DIRECT!!!! just google the name of med. I have all my Meds($1500) thru them BC I can't wk due to FM, Lupus SLE, & Sjogrens. I'm going thru SSI/DI process for the 3rd time. Every PHARMACEUDICAL co has a "Patient Assistance Program". Good Luck & May the Lord give each one of u Supernatural Strength, Courage, Endurance & Faith!!
God Bless,
Kelli <3*•*•*•
I am currently in the process of weaning off of the Cymbalta, so I will see how it goes after that.
You said you take Cymbalta and Savella? What doses do you take?
I am taking both, but still on titration pack for Savella...I was concerned about seratonin syndrome, while taking both. I am still on Lyrica as well.
Pam
I to agree they should get inside the brain.
Wish all a MERRY CHRISTMAS
GOD BLESS YOU ALL!!!!!
sincerely
carolyn
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!
Lyrica and Cymbalta did not help me, so I am eager to try this new med.
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!!!
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!
while using this drug.
I had back sugery 2 years ago & still am still in a lot of pain.
Thank you very much.
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.
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.
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