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Two New Drugs for Fibromyalgia That Actually Work

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Regular readers know I’m very skeptical about the claims of new drugs, especially those advertised on TV with a voice at the end of the commercial reading the side effects at the speed of a tobacco auctioneer (I always listen carefully for “death,” that ultimate side effect).

You’ll see no commercials for either Savella or Xyrem on TV, the first because its manufacturer, Forest Laboratories, doesn’t believe in direct-to-consumer ads. The FDA hasn’t yet approved Xyrem for fibromyalgia, though it will likely get an FDA blessing by year’s end. However, many fibromyalgia physicians are prescribing Xyrem off-label, informing their patients about the pending FDA status. The Xyrem story is especially interesting, I think, but let’s take a look at both drugs.

Savella (milnacipran) has been used in Europe for fibromyalgia for about five years with excellent results. Though they’re largely unaware of it, Europeans are guinea pigs for the American pharmaceutical industry, trying drugs before they’re approved here. Savella acts by raising brain levels of stress-buffering serotonin and a second neurotransmitter, norepinephrine, which is involved in focus and energy. Although milnacipran is a unique molecule, the effect is theoretically similar to combining an SSRI antidepressant (like Lexapro) with a psychostimulant (like the attention-deficit disorder med Adderall).

The clinical results in US studies, which had to be completed before FDA approval, have been impressive. Researchers tracked about 2000 fibro patients, 95% female, after three and six months of taking Savella. They asked about improvement in pain, improvement in overall perception of “positive change,” and improvement of physical function. In all categories, Savella scored significantly greater than a placebo (dummy pill).

Researchers knew what the main side effect would be before anyone swallowed the first pill. When you do anything to raise norepinephrine, you feel nauseated, and nausea did turn out to be the number-one side effect. To avoid this, patients start at a dose one-tenth of the maintenance dose and gradually increase it. Headache and constipation also occur, but less often. Anticipating your next question, no weight gain occurs with Savella.

If you start Savella, any drugs you’re taking that raise serotonin need to be tapered down (not necessarily discontinued, but lowered). Otherwise, Savella can be used with most other medications.

In my own practice, I’m seeing very positive results, with fibro patients reporting significant pain reduction as early as 2 to 3 weeks after starting Savella. The nausea component, if it occurs at all, seems to go away after ten days or so.

Xyrem It was almost 20 years ago when I first learned from a massage therapist that the chemical that would ultimately be released as Xyrem could help fibromyalgia patients. “It’s pretty hard to find these days,” she said. “You know, it’s got a terrible reputation.”

“Terrible reputation” was an understatement. Gamma hydroxybutyrate, or GHB, was available over-the-counter, but was rapidly being withdrawn by the FDA because of its high abuse potential. If you’re thinking, “I’ve heard of GHB…” you’re right, it’s the date-rape drug, a Mickey Finn of a sleep med that’s easily mixed with an innocuous drink for nefarious reasons.

How could GHB be helpful in fibro?

Researchers discovered what fibro patients already knew. On those rare nights where they slept deeply and well, people with fibro had less pain and more energy the next day. With GHB, you undeniably sleep deeply, and back when it was widely available fibro patients who tried it were telling their massage therapists (but not their physicians!) how this drug was helping them.

After years of FDA negotiations, a small drug company got the rights to GHB, sensibly renamed as sodium oxybate. They got rather quick approval for Xyrem’s use in people with narcolepsy, an uncommon condition in which you uncontrollably fall asleep during the day. Over the past year, word leaked out that the company was testing the drug for fibro, but FDA regulations forbade them from talking about it. Recently, however, the clinical trials have been published, with excellent results.

Just as my massage therapist advised two decades ago, get the fibro patient to sleep deeply and she’ll start feeling better.

However, when I first learned about the Xyrem dose schedule, my response was “You’ve got to be kidding. No one will do that.” I was wrong. Despite the strange dose schedule, which follows, patients are willing to put up with it because they do feel better.

1. You’ve got to get completely ready for bed, emptying your bladder, turning off the TV and lights, and getting into bed before taking Xyrem (it works fast).
2. Measure out two doses of Xyrem (it’s a liquid). Slug down the first and turn out the light.
3. You’ll have previously set an alarm clock to wake you in 2 to 3 hours.
4. Wake up, take the second dose, and go back to sleep. (Yes, it’s a re-enactment of the old hospital joke where the nurse wakes you up to give you a sleeping pill). Because the Xyrem is metabolized so quickly, you need the second dose for a full night’s sleep.
5. When you awaken 5 hours later, you know you’ve slept well.

Work with your doctor to make dose adjustments, which are required during the first month.

After about 3 to 4 weeks of sleeping deeply like this, fibro patients sense improved energy and less pain. Side effects are for the most part minor. Some patients report nausea and headache, probably from having such deep sleep. Xyrem can be used with other meds, although naturally any previously prescribed sleep meds become unnecessary and would be discontinued.

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  1. lorie hannah says:

    i suffer from fibromalatia phariatic arthritus and phoriasis

  2. ken says:

    full steam ahead

  3. Linny says:

    You’re right – I wouldn’t do that! First of all, if I am woken up, I can never get back to sleep because the pain comes rushing back and sleep is then impossible! I take half a sleeping pill and get 5 hours. I don’t see the benefit of this. And I never take new medication in a full dose, only 1/4 or 1/2. If a bad reaction happens, a full dose just makes the time until it wears off longer – a small amount is easier to manage. Sounds awful! Probably tastes bad too!

  4. Magela says:

    How you bay this from Canada .
    I have severe pain for more the 10!years.
    I use cymbalta-lirica- porcacet and oxyneo 20 mg .
    Plus sleeping pills .
    I hope something better help people with fibromyalgia .
    I suffer so much!
    Thank you

  5. Deborah Myers says:

    oh my goodness, can it be true, I had such high hopes for Lyrica, too. “When you wish upon a star…”

  6. Carla says:

    I’ve been on Xyrem since 2005. It is my wonder drug! Without it I am bedridden. This is an old article because Xyrem was shot down by the FDA and not because it didn’t work. It works miracles. Studies were shown and people testified. The FDA turned it down because they were afraid of more GHB getting out on the streets but not about our lives. I’m sure many lives would have been saved if they had approved this for us. They felt there were too many with fibromyalgia so we get to suffer. They approved Xyrem for narcolepsy since the population is much smaller.

    My insurance company has started messing with my medications it is only a matter of time before I lose my Xyrem. I can’t imagine living the rest of my life in bed! If someone could find something like this without GHB that would be such a blessing!

  7. Heather says:

    I have used Xyrem and lyrica for more than 5 years. My pain and exhaustion did not disappear, but they got good enough to function almost normally. I highly recommend them. I’m not diagnosed with Celiac Disease but, becoming Gluton free also helped.

  8. Rosemary Lowry says:

    flare ups: always stress related
    Lyrica reactions not good!!
    Massage for Fibro patients not recommended
    I’ve had this condition for many years diagnosed
    by an alternative medicine doctor before my family
    doctor had even heard of it. If doctors haven’t been taught in Medical School, they don’t believe it. Now even Mayo teaches it. Age 84 and better.

  9. Rosemary Lee says:

    This is the first time I’ve been to your blog. Like you, I always listen to the side effects and wait for “death.” I’m not real fond of a lot of drugs that are currently prescribed for Fibromyalgia for that reason. The weight gain of Lyrica, and the fact that it made me very squirrely, was enough to put me off. I’m now interested in Savella. I didn’t realize the fact about the weight gain. I have thyroid issues so I don’t want anything to add insult to injury. I enjoy your writing! Thanks!
    Rosemary Lee
    Seeking Equilibrium

  10. sal_wer says:

    There is a drug now in 2b phase. It approaches fibromalgia by improving sleep quality. It is owned by Tonix pharma and may be finally approved next year.

  11. Robyn mogul says:

    I’m interested About new medications and studies

  12. IDALYS says:

    Finally some hope,about 2008 I read and researched SAVELLA AND TO MY RHEUMATOLOGIST SURPRISE I TOLD HER ABOUT THIS NEW MED.and at THE TIME SHE QUICKLY STARTED ME ON IT BUT FOR ME IT TRIGGERED MY IBS W/constipation so we had to stop it SINCE my constipation can become very difficult to control now I take lyrica but hatE how though it works it makes me VERY hungry within 8-12 hrs.of taking it and at 227lbs.this is the last thing I NEED I’M TRULY DESPERATE TO FIND SOMETHING THAT WORKS VERY WELL IVE HAD THIS CURSE ALL MY LIFE BUT WAS FINALLY DIAGNOSED IN 06,OCT.NOW I’M 50AND OFTEN FEEL AS IF I WAS dying WITH the PAIN and in N.Y. SOME HOSPITAL F O NOT CARE OR TAKE THIS CONDITION SERIOUSLY SO WHAT CAN I DO

  13. Dr E says:

    To IDALYS
    All the new meds that came out for fibro during the past four years (Savella, Cymbalta, Lyrica and Xyrem) have turned out to be very disappointing because of the side effects (many of which you described in your letter).
    My current regimen is a simple one (and I discuss this in my book “Healing Fibromyalgia.” These are: (1) Amrix 15 mg in the evening, a time release muscle relaxant, (2) combined with any of several time release pain meds (Tramadol-ER, Nucynta ER, Opana-ER, Oxycontin). Because for some people the effect of the pain meds declines after three months, changing from one to another works well. Frequently increasing the dose is a bad idea because it leads to drug dependence and addiction. Keep pain med doses on the low side

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Stress Reduction for the Holidays

Wednesday, December 10th (6:30 – 8:30 pm) or Sunday, December 14th (12:00 – 2:00 pm) at Whole HealthChicago, 2522 N. Lincoln Ave, Chicago IL.

The Holiday Season can mean time spent with family and friends, work parties, social gatherings, and the closing of a year. Joyous occasions can also be stressful as to-do lists are longer and anticipation is greater. The closing of the year brings many deadlines, either professional ones that must be met, or personal goals to close the year. For others, the joy of the holidays is overshadowed by a feeling of loneliness, or the loss of a loved one.

Stress Reduction for the Holidays at WholeHealth Chicago will address anxiety and stress that manifest uniquely in each person. Mindfulness and meditation will be used to acknowledge the mental or emotional stress of the holidays, and reestablish a sense of gratitude, contentment from within, and a vision of yourself closing out the year. Gentle movements and breathing techniques will be used to see where we hold tension and stress in the body, and discover how we can open and unlock healing energy.

Pre-registration and payment upon registration is required, as space is limited. To register, call (773) 296-6700.  Price- $30

Renee Zambo is the instructor.

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