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Adrienne Dellwo

The Drug Market for Fibromyalgia & Chronic Fatigue Syndrome: 2012 & Beyond

By January 3, 2012

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The newest fibromyalgia (FMS) drug, Savella (milnacipran), won FDA approval 3 years ago this month. We have yet to see a single drug approved for chronic fatigue syndrome (ME/CFS). Will 2012 see a drug come on the market that's proven to be effective for both FMS & ME/CFS?

The drug Northera (droxidopa) is currently before the FDA, and Chelsea Therapeutics requested Priority Review, which means we should hear something from the FDA by March 28. The New Drug Application is for Northera as a treatment for orthostatic hypotension in Parkinson's disease and related conditions, but early studies have shown promise in FMS and ME/CFS.

Orthostatic hypotension causes dizziness upon standing, when the blood pressure drops instead of rising like it's supposed to. This symptom is common in FMS and ME/CFS in addition to Parkinson's. However, studies suggest Northera is also effective against several more symptoms of FMS and ME/CFS. Chelsea announced last month that Phase II trials in fibromyalgia showed success in several key areas, but those data are not yet publicly available.

Northera contains a synthetic form of an ingredient your body uses to make the neurotransmitter/hormone norepinephrine, which is often dysregulated in FMS and ME/CFS. Some of the drugs shown to be most effective at easing symptoms of these conditions alter the levels or function of norepinephrine.

If Northera is approved and comes on the market this year, it'll be available as an off-label treatment for FMS and ME/CFS.

Not much else is in the pipeline for this year. However, 2011 saw promising research for a cancer drug in ME/CFS that will likely spur further work. Also, scientists announced they'd found a way to remove the "high" from marijuana without eliminating the pain-relieving properties. With several studies showing marijuana is effective against FMS pain, I hope we'll see something develop in this area.

Looking ahead to 2013, there's some good financial news - patent protection will expire for the FMS drugs Lyrica (pregabalin) and Cymbalta (duloxetine), meaning inexpensive generic forms could come on the market. A company has already received FDA permission to begin producing and selling generic duloxetine once the protection ends.

Learn more or join the conversation!


Photo Jamie Grill/Getty Images

January 3, 2012 at 1:40 pm
(1) cort says:

great summary! Thanks!

January 3, 2012 at 8:26 pm
(2) Abot Bensussen says:

When will Xyrem be approved by the FDA? Why is it taking so long? And when will the price lessen?

It’s the only drug that enables me to sleep.

From Your Guide: The FDA rejected the Xyrem application in Oct. 2010 and told the company what more needed to happen before it could be approved. To my knowledge, the company hasn’t yet re-submitted it. ~Adrienne

January 4, 2012 at 2:16 pm
(3) Mona Hickey says:

I have recently heard of a drug called low-dose naltrexone. A friend takes this drug for MS and said that it would also help in the treatment of other diseases, including fibromyalgia. He started with 1.5 mg. and now takes 3 mg, which he buys from a compounding pharmacy. This drug is inexpensive too. Would like to know if anyone else has tried it for relief from fibromyalgia and/or arthritis?

January 4, 2012 at 2:30 pm
(4) Lee Ann says:

Xyrem is only approved for Narcolepsy so far. However, there are Drs that are RXing it for Fibro, but I doubt insurance will pay for it. My Xyrem costs 3400. a month. I pay 35.00. Xyrem used to be sold in health food stores as a sleep aid, and it was cheap, like a dollar a bottle. Jazz got ahold of it and they know they have a moneymaker, they are the only ones allowed to sell it. I think my fibro is much better because I take Xyrem, I can’t take Cymbalta or some of the others, like neurontin. Cymbalta made me gain about 50 pounds before I figured out what was doing it. Neurontin makes me sleep, which is the reason i take Xyrem is to stop sleeping so much

January 4, 2012 at 2:40 pm
(5) RVassel says:

I participated in a study a couple years ago for Xyrem and I found it really helped me with my FMS (almost all my problems were decreased if not eliminated during the year long study). I was hoping that it would be approved by now also. Do we know why this hasn’t happened yet?

January 4, 2012 at 4:47 pm
(6) albertasaurus says:

The FDA has already recently rejected Xyrem as an FMS/CFS treatment. If you have a sympathetic doctor, he may still be able to prescribe it off label for your problems.

January 4, 2012 at 4:59 pm
(7) grace says:

ugh, i thought it was due to lyrica (wt gain) . I gues i should have figured Cymbalta as one of the culprits as well. Full of hope and offer prayers that someone might find a better med to manage fibro “PAIN”

January 6, 2012 at 3:56 pm
(8) Susan says:

Will be glad to see a generic for Cymbalta, although I wish it wasn’t so addictive and I could get off of it. I’ve tried, with doctors help and I read where it’s comparable to heroin as far as the addictiveness.
Asking a question here to Adrienne and others. Have you ever noticed that when u were on an antibiotic that ur pain from fibro lessened? I was on a combo of antibiotics in 2009 and again 2011. My pain went away. Nothing else has ever stopped my pain. My doctor won’t work with me because of insurance and all the test I would have to have. I mean, I find something that helps and all he would do is offer to RX me a $4 penicillin from walmart. Did nothing but give me a terrible yeast infection.
Just curious if anyone else out there has had an effect while on a good antibiotic treatment? I think I am on to something (works for me) but need someone to work with me.

January 6, 2012 at 4:21 pm
(9) eileen says:

i tried savella and it did not help me at all

January 6, 2012 at 4:37 pm
(10) Marti Murphy says:

For Mona Hickey — I began reading about LDN just after I was diagnosed for the second time, two years ago.

My Primary Care Dr didn’t want to know anything about it, as Rxing it for Fibro is off label (it is dosed in 50 mg for opioid dependency). SOOO– I read and read and read, and finally ordered it from the River Pharmacy in Canada. It costs about $139 for ten months. It comes in 50 mg tablets. I grind one into powder, mix it into 50 ml. distilled H2O. I started with 1.5 ml. at bedtime and now take 4.5 ml. at bedtime.

I’ve been taking it about 1 1/2 years, now. It stopped my migraines dead in the water! About half my brain fog, lack of balance, lack of memory, lack of sleep, body pain is alleviated. I has NOT helped my anxiety, IBS, and CF. Xanax for anxiety is great, just staying home till noon for my IBS —- So Fatigue is the main hurdle.

Because I’m retired and 70, I can work around the fatigue by sleeping until I awake (I’m a slug, essentially). Otherwise, life is fine.

I use Soma, Xanax, Cymbalta, Celebrex (for arthritis, mainly), Vit D, d-Ribose, etc. I’m open to questions from anyone on LDN. It works on soothing messages to the spinal cord. I can strongly recommend it, as it has no side effects. Just remember — NO opiate drugs may be taken with LDN.

Hugs to all, Marti

January 6, 2012 at 5:30 pm
(11) Rae says:

Ive been on amitryptilene savella cymbalta lyrica tramadol and some pain killer that was a opiate class it required two ink signatures to get. Savella brought on serotonin syndrome but we tried again, ami took my memory when we got it dosed up, lyrica and cymbalta did nada, the opiate was nice but needed more more more. All the while all the best at ohsu had me on tons of anti nausea meds and IV vitamin treatments. Now on a vitamin regimen and cannabis pain levels down and I’m working full time again.

January 6, 2012 at 5:52 pm
(12) Rae says:

In regards to antibiotics check out my dr at http://www.fmtlc.com he has belief in multiple dormant infections in patients and fibro mimicking human hibernation.

January 6, 2012 at 9:49 pm
(13) marion says:

I have been taking 4.5mg Nal Trexone for several months – have not had any relief from FM/CFS – will finish off what I have left and if no improvement will discontinue – on to the next try.

January 6, 2012 at 10:15 pm
(14) Brenda Lee L. says:

This questions goes out to Marti Murphy: What is LDN?? I gained over 80 pounds in less than 2 yrs while on Lyrica; Cymbalta caused constipation so severe that laxatives wouldn’t even work; so I quit both and am back to where I was initially. Need Gabapentin for restless legs, etc, but am wondering if there isn’t something that works better for my fibro. Many thanks for all info!!

From Your Guide: LDN stands for low-dose naltrexone, which has shown promise for both fibromyalgia and chronic fatigue syndrome. ~Adrienne

January 7, 2012 at 7:41 am
(15) Margie says:

. My 19 yo daughter has FM. We have Kaiser so there is no help there.. Savella is not even in their formulary.. She was being given Vicoden, that helped a little but made her drowsy. We live outside of San Diego and Medical Marijuana is legal here. I grew up in the 60′s and used it when it wasn’t legal She tried it and it has worked wonders for her. No more Vicodin. Marijuana was legal in this county until the 1930′s, It was made illegal in response to immigration problems. (i.e. Mexicans used marijuana and real Americans drank liquor.) Also Wm Randolph Hearst pushed to make it illegal as he owned paper mills and hemp, the plant marijuana comes from, is cheaper to grow and makes paper cheaper than lumber. Anyway, marijuana has been used as medicine all over the world for thousands of years.. It is not the evil drug the US Government purports it to be. It is not addictive. It has made the difference between night and day for my daughter. She actually sleeps and functions at a part time job. Anyhow, I would try it if nothing else helped. The medical community really just isn’t jumping in to find solutions to the FM problems.

January 7, 2012 at 8:01 am
(16) linda says:

When will Savella be available in the UK???

From Your Guide: The drug in Savella, milnacipran, is also in Dalcipran and Ixel, which are both available in Europe – although I don’t know specifically about UK. ~Adrienne

January 7, 2012 at 11:15 am
(17) Sarah says:

I feel that doctors (especially non-psychiatrists) are dispensing prescriptions for anti-Ds and SSRIs like candy which is very dangerous if they are not fully aware of a patient’s family history. Savella, Cymbalta, etc. are perfect examples of that.

What about GcMaf? It’s for cancer treatment, etc. and now being “loosely” tested on patients with ME by two physicians to my knowledge. The catch is that people have to pay out of pocket since the gov’t has not (will not?) fund a research project for it…not yet, at least. I’ve met quite a lot of people of all ages trying it, and so far, there’s been a noticeable improvement with no adverse reactions. Here’s hoping! :)

Ampligen is also finally being tried on ME patients in the USA. So far, of the patients I know, they’re experiencing the Herxheimer Effect…which is a “good sign.” We’ll see.

We need funding and for medical students to become extremely interested in ME. The main reason they don’t go into it is because it’s very difficult to get funding for research for their papers, etc.

Thinking caps on… ;-)

January 7, 2012 at 12:07 pm
(18) arwyn says:

Great news for 2012 cant wait to speak to my GP.

January 7, 2012 at 12:16 pm
(19) Maria says:

For Mona Hickey: I nagged my Rheumatogist for over a year to try LDN. Finally this past July he agreed to let me try since he now found a compounding Pharmacy to work with. Started at 3mg for 6 weeks then went to the max dose of 4.5 mg. I have CFS and FM. My strength has improved to the point I can now climb stairs, knead bread, and most amazingly of all….pick up and hold my grandchildren! I’m sleeping better, my pain level is down to almost nothing, stiffness down to almost nothing, when I over-do I no longer get horribly sick, and I no longer get a migraine when exposed to heavy perfumes. I still can’t drive on the freeway but I feel more comfortable when I do drive. I’ve been able to be much more active. Since you cannot take opioid pain killers with LDN I was concerned that with the coming winter I would have more problems with pain, I increased my 5HTP from 200mg to 300mg and that has helped tremendously. So far so good. Mild sleep disturbance during first 2 weeks of taking LDN….then no side effects at all. I strongly encourage anyone interested to research as much as they can and then talk to their Doctors if there’s interest in trying it. It doesn’t make you ‘back to normal’ but it sure has improved the quality of my life. Take care all!

January 7, 2012 at 12:21 pm
(20) Maria says:

A few things I forgot to mention: The compounding pharmacy in my area (Southern California) charges $60.00 for a 30 day supply and they mail it to me since they are a bit far from me. My insurance (Anthem Blue Cross) amazingly covers it so I just pay my regular co-pay.

January 8, 2012 at 4:10 pm
(21) Judy Roberson says:

I have struggled with fibromyalgia for probably 25 years atleast. All the doctors thought I only wanted pain medications even when I kept telling them that pain meds. wasn’t working and I needed someone to really try and find out what was wrong with me. Finally after going from doctor to doctor one actually said that I really had a problem but that it was something that no-one really understood. I have been taking one of the strongest pain medication now for almost 6 years now ( Oxycontin ) it does not stop the pain, I am now a drug addicted person whom the doctor’s refuse to help come off of, a drug they put me on. I have actually lowered the dose myself from 80mg twice a day now down to 40mg twice a day, but have gotten to the point I cant cut the med. in half and the doc. won’t help me come off it so I feel as if I’m fighting a losing battle. I stopped the meds. myself and ended up in hospital going through withdrawals and almost died from it. They tried adding Savella to help the pain but my kidneys shut down and because I am dietbetic my blood sugar shot up over 700. Does anyone else seem to have problems with Savella that way? Also the other med. Lyrica didn’t work for me either, and Cymbalta made me sick to my stomach. I am so tired of taking Oxycontin, I have aged 20 years since I started taking it. I feel that I am dieing and the doctors just don’t care as long as they make their money and the drug company makes theirs. Marijuana is not legal in this state but I did smoke it when I was much younger and lived in California. Does it really help? I am to the point of trying almost anything, only trouble is I wouldn’t even know how to go about getting it and don’t want to go to jail for using it.

January 8, 2012 at 5:05 pm
(22) Judy Roberson says:

In my last comment I went on about what I have tried and what hasn’t worked for me. But I have no idea what any of these other med’s. are nor has any of my doctors tried anyother than those I have mentioned. If you can give me any other advice that I can take to my doctors please e-mail me at highongod1@hotmail.com I wouldn’t usually give my e-mail address but I am desperate. Thanks for any help…..

January 9, 2012 at 4:43 am
(23) Kim says:

@ Maria Can you Please tell US what LDN is??? Thank You

January 10, 2012 at 9:32 am
(24) Rae says:

LDN is low dose Naltrexone http://chronicfatigue.about.com/b/2010/05/20/information-on-ldn-for-fibromyalgia-presented-at-conference.htm

Ive never been on but just a quick web search even on this site revealed multiple pages.

As to the question Judy posed about medical marijuana – in an anti medical marijuana state its illegal point blank regardless of medical condition. In a legal for medical marijuana state its still federally illegal although Obama claimed he planned to leave patients alone, the feds are attacking the only semi legal cultivation and distribution systems. That said all I can offer you is that fibro took away my control, my control over pain, whether i can go to places, even my day to day life and frankly there was some great pleasure in cultivating my own meds, where I control how my meds are grown, I take them when I need and adjust dosage as needed and do not just pump chemicals into me on a daily prescribed basis.

You can find many forums that will assist you in learning more on the web. But I reiterate in a nonlegal state you are making a choice to do something illegal. Just don’t think being in a medical state allows you protection from any trouble, what it does is give you a legal leg to stand on should someone stick their nose into your health management. I lost one very good job over it and while a case was won in Oregon a year later when your firm is owned by lawyers you don’t have enough resources to take on that fight. I chose at great expense to my family and myself to pick up my life and move it 700 miles south to a state where the hope of more progressive legislature and guidelines are on the books. Its still a challenge but inch by inch and sometimes just clinging to the same point I am getting my life back. I dont know that I will ever again be the sassy, rambunctious, energetic, sleep when I’m dead person I was 5 years ago but I have more and more days when I find just a little bit of joy somewhere.

January 10, 2012 at 10:16 am
(25) Rae says:


I re-read your post and sorry but empathy got me, I’ve been there not with oxy but vicodin. Before I was diagnosed they pumped me full of vicodin post gall stone attack with acute pancreatitus, followed with gall bladder removal. The trauma (I was on death bed for 4 days as the pancreatitus was at record high levels for the health organization) made my fibro rear its head and I was undiagnosed. Kaiser’s answer vic-vic-vic and more more more for 8 weeks then refuse to refill over holiday weekend and I junkied bad. from 8 vics a day to 2 to nothing for 4 days. WHen diagnosed a year later at OHSU I lit up like a neon sign on all trigger points, when they retested them I was screaming.

What Medical MJ does for me-

First off I have not gotten “high” in forever, my FM blocks most of my brain transmitters from the good sensations like joy, pleasure, etc. MJ quiets my fibro – I think of it like vibrations once they start to hit each other I go from discomfort to agony in a heartbeat. It keeps the vibrations from rumbling. It also quiets my nausea which was been intense since the pain pills compounded by the fact I had gastric bypass 10 years ago.

It doesn’t do a lot for sleep but does help me a bit. I still have the occassional day where the pain overtakes me but I’d say its down to 5-10 rough days a month with maybe 1-2 horrid days when the weather changes, where before I was living in agony about 95% of time.

CBD strains didn’t work well for me but Indica strains do. It takes me roughly 4-6 months and a cost of about $750 to cultivate 6 months of medicine. The cost is primarily the electric to run indoor lights. A basic setup can cost you a one time cost of about a grand for a self contained closet tent style unit. With my vitamin regimen it runs me about 150 a month. Before I was on 2 anti nausea meds and various pills costing about $250 a month plus $150 in dr co pays.

February 20, 2012 at 12:57 pm
(26) Jim says:

Many interesting comments here. What works for one doesn’t work for another, etc. My psychiatrist prescribes me Aricept, a medication for early stage Alzheimer’s, and it has worked extremely well in reducing Fibro Fog. Cold weather this winter has reduced it’s effectiveness, but I’m much better off than I was before beginning the drug. As for pain, I take Lyrica at night along with Xanax 0.5 mgs., melatonin, and Trazadone 150 mgs. (generic Desyrel). The Mayo Clinic put me on the Trazadone in 2001, and I sleep like a baby. I have no medication induced fatigue or drowziness in the morning. I have enough Chronic Fatigue to last me a lifetime so I don’t need to add to it via the medication route. For pain, what works best for me is Darvocet 100 mgs. t.i.d. Darvocet is no longer legal in America, Europe, and Canada after 55 years on the market. It was taken off because accidental suicide was sometimes a problem. Doctors have a concern because of the 400 mgs. of Acetaminophen (Tylenol) in each dose. I am aware of these problems and am cautious. I get the Darvocet from a company in India. It costs about $88/month. I pay for it via eBillme. I have tried all of the pain regimes mentioned on this website. Lyrica works well, but I put on too much weight. I am again on Cymbalta-works well. I also take Xanax 0.5 mgs. during the day, but, frankly, I think that I could have benefited from it prior to getting M.E. in 1996. Supportive psychotherapy with an LCSW is recommended. Psychologists are a one-trick-pony with their cognitive behavior therapy. CBT is highly effective for certain problems, but they try to use it for all problems. Makes them a lot of money! LCSW’s, I have learned, are educated in bio-psycho-social treatment: biology, psychology, and sociology, and are quite opened to our problems. They also have a focus upon social functioning, which is a real problem for us. I wish everyone good luck. I have severe FMS and M.E. so I can empathize with all of you. God bless.

March 25, 2012 at 10:37 am
(27) Shelley says:

I have RSD, FM & RLS – and have gotten them in that order.
Over the course of 10 years I have graduated from Percocet, Oxycontin and now on Opana ER. Opana is longer acting that Oxycontin so I don’t have withdrawls between dosages.
Opana is nearly twice strength of oxycontin.
In addition I also take Lamictal, Savella, Wellbutrin, Novigil (helps keep me from daytime drowsyness) and Doxipen. I have also found the Flexeril really helps with the RLS.
In my history of taking opiates, I have never gotten the “high” that most illicit drug users seek. Many other with chronic pain also don’t experience it. I am drug DEPENDANT, not ADDICTED.
Thankfully, about $600 a month for these drugs are paid for by Worker’s Comp.

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