New drug relieves pain from Fibromyalgia

The Commercial Appeal ^ | 2/17/03 | NA

[GailA]

New drug relieves pain from Fibromyalgia February 17, 2003

Conventional medications, such as Tylenol, Motrin or even morphine, provide little relief to sufferers of fibromyalgia, a mysterious and debilitating pain disorder. But a new drug might be able to thwart the nerve signals that scientists believe trigger the pain.

"This is a real breakthrough not only because it works, but it proves fibromyalgia can be treated," says Dr. Leslie Crofford, a rheumatologist at the University of Michigan in Ann Arbor who has studied the new drug, pregabalin.

The syndrome affects an estimated 5.6 million Americans.

Pregabalin reduces the release of specific brain chemicals, such as glutamate and noradrenaline, that may cause pain, says Terry Griesing, a neurology researcher with Pfizer Inc.

The drug, which still needs FDA approval, could be on the market as early as 2004.

[GailA]

FYI for my fellow suffers of Fibromalgia.

[Jen]

This is good news!

[Ff--150]

ping

[Wait4Truth]

Thanks, Gail. My sister suffers from fibromyalgia. I emailed the article to her.

[Damocles]

Thanks for the info. My Grandmother-in-law has been dibilitated by fybromyalgia for years and has tried every medication known (legal and illegal) to try and gain relief to no avail.

I'll pass this info along.

[bigfootbob]

"The drug, which still needs FDA approval, could be on the market as early as 2004."

Hold on to some of that enthusiasm. I wouldn't hold my breath waiting on FDA approval next year, especially when it comcerns pain relieving medication. I've had DJD for 26 years and I've never seen a slower or ineffective regulatory agency.

[mathluv]

Are there any trial programs?

[valleygal]

I, too have FM. Take a look at www.fibromyalgiatreatment.com.
I began taking guaifensin a few weeks ago. It's supposed to help the kidneys get rid of phosphates that build up in our cells because our bodies can get rid of it like it should.

Guaifenesin is supposed to reverse fibro not just treat the pain. Kind of restrictive, though. Can't use any skin products with salicylates in them (or plant extracts) or take aspirin. One company does make salicylate free products, though.

If anybody has other info they can pass on, I'd appreciate it. My mother has FM very, very badly. Nothing has helped her. She hasn't tried guai yet. And I haven't been on it long enough to know for sure this is going to be the answer.

[GailA]

Because of my inability to take many meds due to gastro-intestinal side effects I use mainly natural remedies for my FM. Malic Acid, St John's Wort, MSM and mild stretching exercise (which I'm very bad about not doing as regularly as I should.

Be sure you've had your Thyroid functions checked as most FMS sufferers are also Hypothyroid too.

SITES FMSnewtnews

http://www.ivillagehealth.com/library/nwh/content/0,,215912_227084,00.html">Ivillagehealth

healthrevolution

[GailA]

Not that I know of, check the drug company to see if they do.

[buffyt]

My college roommate takes Paxil and Elavil for it. She takes one drug by day and the other one by night. I ran this by my doctor and he said that drug mix is a no no. But Jeannie has been taking this drug mix for many years. Without them she was unable to do anything. With them she is able to teach school every day.

[Patriotic Bostonian]

This is fantastic news! I too suffer from Fibromyalsia.

[Plutarch]

Amer College Rheum Annual Meeting Presentation Oct 2002

Pregabalin Improves Pain Associated with Fibromyalgia Syndrome in a Multicenter, Randomized, Placebo-Controlled Monotherapy Trial

Leslie Crofford, I. Jon Russell, Philip Mease, Ann Corbin, James Young, Jr., Linda LaMoreaux, Susan Martin, Uma Sharma, Lloyd Knapp, Mark Versavel, R. Michael Poole

Purpose: Fibromyalgia syndrome (FMS) patients experience chronic widespread musculoskeletal pain in association with fatigue and sleep disturbance. There are no approved therapies, and treatments that are used often do not provide adequate relief. This 8-week randomized, double-blind, placebo-controlled, parallel-group monotherapy trial evaluated the efficacy and safety of pregabalin up to 450mg/day (150 mg TID) for reducing pain and associated symptoms in patients with FMS.

Methods: Patients meeting the ACR criteria for FMS completed a 1-week baseline phase and an 8-week fixed dose treatment phase (6 required visits). Patients (n=529) were randomized to receive placebo, 150, 300 or 450mg/day pregabalin at Visit 2. The primary efficacy parameter was pain, recorded by patients in a daily pain diary, using an 11-point numeric rating scale. The primary analysis was based on the endpoint mean pain score. Secondary efficacy measures included the Short Form McGill Pain Questionnaire (SF-MPQ), sleep quality diary, Medical Outcomes Study (MOS)-Sleep Scale, Multidimensional Assessment of Fatigue (MAF), Patient and Clinical Global Impression of Change (PGIC, CGIC), and SF-36 Health Survey.

Results: Pregabalin-treated patients (450mg/day) showed significant improvement in the endpoint mean pain score (-0.93; p<0.001) compared to placebo, and were significantly more likely to have 50% reduction in pain from baseline (29% vs. 13%, p = 0.003). The mean SF-MPQ total pain descriptor and visual analog scale (VAS) scores were significantly improved at each visit and at endpoint for the pregabalin 450mg/day treatment group compared to placebo. Mean sleep quality, fatigue, CGIC and PGIC scores at endpoint were significantly improved for patients receiving 300 and 450mg/day pregabalin. The MOS-Sleep Index score was significantly improved at endpoint for all doses. Four of 8 domains of the SF-36 were significantly improved at endpoint for the 450mg/day treatment group. Overall, 48 patients (9%) withdrew due to adverse events and 44 patients (8%) due to lack of efficacy. The most common adverse events were dizziness and somnolence. Most patients (78%) completed the trial and entered a follow-on safety trial.

Conclusions: Pregabalin is effective and safe for the treatment of pain at 450mg/day in patients with FMS in this study. Pregabalin additionally improved sleep quality, fatigue, global measures of improvement and quality of life.

Keywords: fibromyalgia, pregabalin, pain

[republicandiva]

Thank you, thank you, thank you. I will watch as this drug makes it through the approval/rejection process. It might be worth our while to form as a group to "encourage" approval, or at least speed along the testing process. I'm currently managing my existence on steroids, muscle relaxants, Vioxx and occassional narcotics. Not sure how long some of my organs will keep tolerating some of these drugs, but the docs have hinted something like this might be coming. I know others that are narcotic dependent (addicted) and this would be a God-send. Let's keep our fingers crossed this proves to be an answer.

[Aggie Mama]

Well, I can tell you from personal experience that my "miracle" cure has been a combination of progesterone and Armour Thyroid.

All of the doctors that I went to said that those levels were normal. My mother stumbled upon a doctor that truly understands hormones, and when I went to him, it was a gift from God. All of the weird and painful symptoms that I had were things that he saw several times a day in his practice. I became symptom free after 4 months of treatment. It literally changed my life.

Do a google on Armour Thyroid or hypothyroidism and fibro. There's lots of info out there, but it takes a special doctor to be able to put the pieces together. Feel free to freepmail me if you have any questions.

[valleygal]

I have used malic acid, MSM and done the mild stretching as well as working out on the treadmill.

Guaifenesin is over the counter and is an expectorant found in cough medicines. Not supposed to take it in that form however, just the pure guai tablets.

I was on a low dose of Elavil years ago. Didn't like it. Made me too groggy in the morning. If you take a higher dosage it makes you want to eat all the time (my sis gained quite a bit of weight while on Elavil).

[republicandiva]

I have a problem with GERD, not sure if that's your problem or not. I take tagament on a regular basis because of this. I've found Vioxx can be a little difficult, but I will often cut the doseage. You might, however, want to ask your physician about Flexeril (Cimetidine - generic). It has absolutely NO GE side effects, but does wonders to relax the muscles at night and allows for better sleep...which in turn often lessens the triggers to Fibro. Just a thought, if you haven't already tried it.

[Concerned]

There is a DRUG-FREE PRODUCT on the market which is FDA-approved for anxiety, depression and insomnia. It has also been found to VERY helpful for fibromyalgia.

There have been something like 126 human studies and 29 animal studies.

[valleygal]

Thanks, AM. I already use natural progesterone cream. Does that count? :)

[valleygal]

And the drug free product is...?