Promising Drug to Treat Fibromyalgia May Never Be Approved by FDA

Promising Drug to Treat Fibromyalgia May Never Be Approved by FDA

Over 6 million Americans suffer from fibromyalgia, a disorder that causes chronic pain, muscle soreness, moodiness and fatigue. Fibromyalgia is difficult to treat and there is no known cure.

Researchers at Stanford University’s School of Medicine have conducted two small studies showing that low doses of naltrexone, a generic drug currently used to treat drug addiction, can reduce fibromyalgia symptoms by as much as 50 percent. However, the FDA has not approved the use of naltrexone to treat fibromyalgia, so it is only available through “off label” use.

American News Report Editor Pat Anson spoke exclusively with Stanford researcher Jarred Younger, PhD, who presented his latest findings about naltrexone at the annual meeting of the American Academy of Pain Medicine.

Jarred Younger, PhD. Photo courtesy Stanford School of Medicine.

You’ve been working on naltrexone for awhile and it shows a lot of promise for treating fibromyalgia. A layman would ask, why can’t it be prescribed for fibromyalgia?

I think what physicians are waiting for is the gold standard through clinical trials. With one study, which is all that’s been published so far, we can’t really recommend, especially with the low sample size, that people change prescribing habits. With two studies, that’s more interesting, but really you need the large study, hundreds of people to try it, before you can be really confident that this is going to work for people. I know some physicians who have tried it but you won’t expect the majority to touch it until it has larger trials.

When you talk about “off label” use, what does that mean?

It’s very commonly done. The off label just means is that no one has gone through the FDA process of getting approval for that particular application. And the reason why that’s never going to happen for naltrexone is that it’s already generic, so there’s no financial incentive for any pharmaceutical company to go through that multi-million dollar process to get FDA approval. So this will always be generic, it will never have FDA approval unless someone comes up with a new way of administering it. This will always be off label. That doesn’t mean anything’s wrong. Many drugs are given off label. It just means it won’t have that ultimate stamp of approval for that reason.

Nobody can make money from it, so it’ll never be widely used for fibromyalgia?

It’s an expensive process to get that approval. The FDA has a lot of criteria you have to go through and there’s no incentive to do it. So it’s up to the academic centers to do the trials and the National Institutes of Health to fund it.

What is naltrexone’s history? And what is it most commonly prescribed for now?

It’s been used clinically for over 40 years and it’s typically used for opiod addiction. So when you give it at 50 milligrams to 100 milligrams, which is the typical dosage, it blocks your opiod systems. And if someone is addicted to heroin and they have naltrexone in their system, the heroin won’t do anything. It blocks those effects. So it helps people wean themselves off of their opiods.

So it’s kind of like methadone?

Yes. Methadone has some positive opiod actions as well. You can get a little bit of a euphoric effect from methadone. Naltrexone will stop that in its tracks. In fact, if you were on a high level of an opiod and you took naltrexone, you would feel pretty crappy because it takes opiods out of your system.

Can you describe in layman’s terms how naltrexone works on the nervous system?

I’ve used the metaphor that naltrexone may be aspirin for the brain. Aspirin reduces inflammation in the body, so this may be the equivalent. It may be something that reduces low level inflammation in the brain and the spinal cord. Now, we can’t know that for sure, because we haven’t done the studies, but that’s what I think is happening. It’s basically quieting things down, quieting the immune system that’s hyperactive, reducing a lot of the symptoms of fibromyalgia.

You’re clearly excited about your research. Do you feel frustrated that you’re onto something and it’s time naltrexone was widely used for fibromyalgia?

I am fine with people waiting for that big trial. We’ve got one trial with 10 people. We’ve got a second one with 30 people. This next one, if we can get funding for it, will have hundreds of people. So I totally understand why physicians are wanting to wait. And I think the fact that they’ve had me here to talk about it shows that they’re interested in it. They want to hear more. So I think the response so far has been actually pretty good. I get emails everyday from physicians who’ve tried this. Pretty good, considering how small the studies have been.

And what about people with fibromyalgia? When they read about this, do they go to their physicians and say I want naltrexone?

Any physician is legally able to prescribe this. Anyone can do it. It’s just a matter of whether they want to or not. Some physicians will say let’s give it a shot, let me monitor you. Some physicians will say absolutely not.

Your 50 percent success rate is pretty good.

It’s pretty good, yes.

Do you see naltrexone as something that will cure fibromyalgia or something people would have to take the rest of their lives?

I don’t think it addresses whatever originally caused the problem. I think it’s quieting it down, but I don’t have any evidence that it’s fixing the problem. This is a maintenance thing. It’s something they would probably take everyday for the rest of their life. But it does allow a lot of people to reduce their other medications. Instead of taking ten, they can get it down to one or two. Overall, that’s pretty good for them.

Thank you, Dr. Younger.

Authored by: Pat Anson, Editor

There are 10 comments for this article
  1. M Veenendaal at 12:49 am

    LDN made my IC bladder painfree!!

  2. Marsha Rodriguez at 8:49 pm

    This is the most promising information I have read in a very long time. I’m on SSDI & the med’s I take are draining all of our money. The co-pay’s for generic medication’s are being increased constantly & even through I only take 1 brand name rx for I.C., my generic extended release pain med went from a $6.00 co-pay to a $45.00 co-pay because there are now 2 tiers for generics. Preferred and non preferred. I would like to stop all the medications but if I could take 1 instead of 10 that would be a major improvement.

  3. maureen Connor at 2:19 am

    Very interesting article & well worth following up.

  4. D. Gale, C.Ht-IST at 9:00 am

    Debbie, it’s definitely “Naltrexone” and not Naloxone.

    I am taking 5.0 mg of Low Dose Naltrexone right now.

    I imagine a couple million sufferers of CEBV, Interstitial Cystitis, Celiac, Crohn’s, Diabetes, Hashimoto’s, cancer and a huge list of other conditions are finding relief. Check out https://www.facebook.com/groups/LDNRT/ on Facebook.

    Low Dose NALTREXONE is an immune modulator (besides being an opiate antagonist).

    LDN will modulate the immune system in whatever way you need — up, down, or sideways…
    and can put pretty much every immune and autoimmune condition into remission.

    Reactions to LDN are hardly ever heard of.

    Google “LDN” and “LDN+your condition”. Check it out here, as well: http://www.lowdosenaltrexone.org/

    Joni, the usual prescribed dosage for LDN is 4.5 mg. .002 was definitely not going to put me into remission!
    If I were you, I would get back on it and titrate up to 4.5 mg, or slightly higher depending on “your” optimal dose.

  5. D. Gale, C.Ht-IST at 11:58 am

    Low-Dose Naltrexone put all of my immune and autoimmune conditions into remission. I take 5.0 mg instead of the usual 4.5. IT WORKS for me and hundreds of people I have met as an LDN advocate over the years.

  6. Joni Lewandowski at 10:46 pm

    I tried Naltrexone 0.002 mg I did not feel a difference but you are talking much higher doses. I would be curious to find out, I have fibromyalgia and cfs. So I’m in pain all the time.

  7. debbielee repscher at 4:20 pm

    is naltraxone the same as suboxone with the same effect? suboxone had an artifucial sweetner in it I am allergic to, is it the same with naltraxone? I have had fibro severe since 1995 and it has ruined any quality of life I could have ever hoped for…I moved from CT, where I had excellent care from Dr Mark Thiminer, to now northeastern North Carolina where I cannot find a decent pain clinic anywhere and now I am on no medication what so ever…I do not know what to do now, the dr. I saw does not believe that fibro exists and with medicaid I am very limited but in desperate need of help. I wonder how many fibromyalgia sufferers commit or think about suicide as a solution to stop the maddening 24/7 pain that never ever lets up on us fibro people? the FDA really needs to get moving on helping us fibro people we are in desperate need of help so much and I do not believe that they are even aware of how bad it really is…..thank you debbielee

  8. Pat Anson at 7:48 am

    Renee, I can’t “recommend” anything. I’m a reporter, not a doctor. But to answer your question and for informational purposes only, the dosage used in the Stanford study was 4.5 mg naltrexone daily.

  9. Renee at 7:32 am

    What dosage for the the maintenance of Fibromyalgia do you recommend????