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  • Lyrica (pregabalin) waiting FDA approval. Possible med for FM?

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    Old 05-17-2005, 10:57 PM   #1
    tkgoodspirit
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    Exclamation Lyrica (pregabalin) waiting FDA approval. Possible med for FM?

    Hi ya'll! Me again! Here's some promising info about a new medication. (We'll see!)

    Once again, here is my CYB statement: The following information has been taking from research and articles obtained by me. Nothing here is copywrite protected. This info is meant to be shared. Some info is in quotes, but has been paraphrased. All other info is taken from bits and pieces from my own personal information.

    curlynhmom: I believe this is the information you were interested in.
    This thread kinda picks up where my thread about FM being a disease leaves off, which referred a lot to specific neurological effects that are thought to cause FM. The following question refers back to that thread:

    What about currently available drugs that target neurons? An M.D. at Harvard Medical School says "that the loss of ability to filter out pain signals entering the spinal cord is one of the main consequences of CNS disease". (quoted but paraphrased)

    A special subset of neurons in the spinal cord works to increase GABA, an neurotransmitter that helps minimize the effects of incoming pain signals. Most of us are familiar with the medication Nuerontin (gabapentin) that is prescribed as a CNS pain receptor inhibitor. When the effects of incoming pain signals are minimized, this also reduces the other cascading events, such as Glia activation, substance P production and futher degeneration that leads to the release of NGF (Nerve Growth Factor). All this going back to my thread regarding FM as a Disease.

    The belief that drugs that increase the stability of the GABA-responsive neurons may interrupt this vicious cycle. (also referred to in my thread about FM as a Disease)

    Bacolofen is supposedly the most powerful drug in this class but it is very sedatative. Neurontin is a GABA boosting med but its chemical "action" is different and it doesn't benefit all people with CNS pain. As some of us who have used it and quit using it, know.

    Lyrica (pregabalin) is soon to be released and is believed to be more effective than Neurontin. In January of this year, Lyrica was approved by the FDA for the treatment of neuropathic pain, specifically postherpetic neuralgia. ( neuropathic pain = an abnormal and usually degenerative state of the nervous system or nerves, postherpetic neuralgia = acute spasmodic pain along the course of one or more nerves ).

    Lyrica is manufactured by Pfizer and it is trying to get it approved for the indicated use of FM. Pfizer also stated in a recent press release that this drug will be regulated by the DEA as a controlled substance. Neurontin is considered a "cousin" of Lyrica and has been on the market for 10 years with a great safety record (according to the FDA) which is why it isn't regulated by the DEA.

    So why is Lyrica being treated differently than Neurtonin? There was a clincal trial using Lyrica to treat the "core" symptoms of FM: those being pain, sleep disorder, and daytime fatigue. This study has shown that Lyrica is effective and well-tolerated at a dose of 450mg per day. Lyrica works by with a "mechanism" in the CNS to increase the neurotransmitter GABA. GABA is thought to help filter out pain related signals before they reach the brain. A blocking agent, so to speak.

    A study in lab animals shows that Lyrica significantly increases the amount of time spent in deep level restorative sleep. Good! So for people with FM, Lyrica seems to be a promising medication option. But until the DEA decides what schedule rating to assign it, Lyrica won't be available for prescription sale. We've all heard of the new DEA regulations regarding schedule II drugs and the strict rules PM docs and clinics have to now follow regarding the way prescriptions are written for these class of meds. Supposedly, the decision by the DEA is due soon.

    Pfizer is conducting studies to show the positive effects of Lyrica for FM patients and it is commited in finishing the studies needed to obtain FDA indicated use of Lyrica for FM. While Lyrica was developed for other uses, Pfizer has put a lot of focus on the eventual approval for Lyrica to be indicated for FM, more focus on approval for FM than what Lyrica will initially be approved for. So, when Lyrica is approved for prescription, it will be written for "off label" use to treat FM.

    A member of the Lyrica treatment and clinical trial team states: "No drugs are currently indicated for FM and due to the newness of the situation, it will probably be another 2 years before Pfizer is able to gain the FDA approval for use in FM." I'm not quite sure what this means, but according to the article I have, Lyrica will be approved soon for the initial "conditions" it was developed for, just waiting to see if it needs DEA regulating. The article DOES say that the FDA trusts the knowlegde of the medical proffessional to determine proper dispensing of some medications for "off label" use. Which is the kind of meds us Fibromights usually end up with anyway, since there are no meds specifically designed and made to treat FM. We get the "hand me down" meds! LOL I think what they meant by approval in two years, simply means that the drug Lyrica will include FM as one of the conditions it is designed to treat. Lyrica will no longer at that time (estimated time!) will be considered an "off label" drug for us. It will be considered a drug for the treatment of FM.

    So, there you have it. Another med to try out! Yippeeee! The idea that it works to restore deep sleep patterns, is promising.

    Okay, my friends, I'm done for the night. I've been posting and "gleening" info since 7:00 p.m., it's now 1:00 a.m. I have to see my new Neurologist tomorrow, see what he says about my little brain! I read MomwithMS's post about her new doc and I want to go where SHE is! How cool is that?

    Anyhoo, COMING SOON TO A THREAD NEAR YOU! "Laughter: The medication proven to help the symptoms of FM"

    Love you all,
    tk

    Last edited by tkgoodspirit; 05-17-2005 at 11:05 PM.

     
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    Old 05-19-2005, 11:00 AM   #2
    tkgoodspirit
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    Re: Lyrica (pregabalin) waiting FDA approval. Possible med for FM?

    bumping up!

     
    Old 05-20-2005, 09:20 AM   #3
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    Re: Lyrica (pregabalin) waiting FDA approval. Possible med for FM?

    TK another informative and good post. Looks like we are in that waiting game as always. I think we will be better off with the laughter!!!!

    Thanks so much for your effort, hope all goes well with your neurologist

     
    Old 05-20-2005, 09:28 AM   #4
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    Re: Lyrica (pregabalin) waiting FDA approval. Possible med for FM?

    Hey Glojer! Yeah! Somebody replied to Lyrica! I was hoping someone would, that's why I bumped it up. I knew I could count on you!

    I posted my experience with my Neurologist appt in a new thread, called: "Raspberries to my Neurologist!"

    Let's just say, it wasn't what I had hoped for and I'll be looking for a second opinion.

    Love ya!
    tk
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    Old 09-02-2005, 01:26 PM   #5
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    Re: Lyrica (pregabalin) waiting FDA approval. Possible med for FM?

    Hi All, I just saw my PM yesterday and he said this med. should be comming on to the market anytime now.
    He didn't start me on a new med yesterday as we just tried 3 in the last 3 months and I had either allergic reactions or terrible side-effects.
    He is putting me on it for my nerve pain as my PM doesn't have much to say about fibro. my rhuemy takes care of that end but it looks as if this new med may not only help my nerve pain but the fibro also.
    I have been getting some good info on it, the one side effect that I still don't like is the possiblilty of weight gain yuk..
    I just wanted to let you all no hope is close.
    I know of some people that are getting scripts and sending to Canada for the meds, I don't want to do that, I'm just leery.Hope you all have a fatastic week-end and keep all of our southern friends and family in your thoughts and prayers.
    Linda

     
    Old 09-02-2005, 04:58 PM   #6
    Glojer
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    Re: Lyrica (pregabalin) waiting FDA approval. Possible med for FM?

    Jdlfmc thanks for the info. What meds don't put weight on, seems like everything these days (except topamax) has that side effect.

     
    Old 09-02-2005, 05:22 PM   #7
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    Re: Lyrica (pregabalin) waiting FDA approval. Possible med for FM?

    Glojer, I don't know why but my PM dr doesn't want to RX topomax for me he said he finds it works well for headaches but not for nerve pain like I'm experiencing, I may push him in to trying it anyway.
    Especially if lyrica isn't on the market by my next app. I've already tried all the other anti-seiz. meds they use for nerve pain.
    Linda

     
    Old 09-02-2005, 05:57 PM   #8
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    Re: Lyrica (pregabalin) waiting FDA approval. Possible med for FM?

    Jdlfmc, I think we had a post about topamax and/or someone who was using it for fibro and migraines. I think if I got to that point where I needed more pain management than I have already I would certainly give it a try. Trying is one thing, if it doesn't work give it up. It is all about quality of life for me not quanity. That's not to say I don't want to be around to see my grandson hit his first grand slam out of the ballpark (he is just 3yrs. old) but I also want to be able to enjoy seeing it.

    Last edited by Glojer; 09-02-2005 at 05:57 PM.

     
    Old 09-08-2005, 06:15 AM   #9
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    Re: Lyrica (pregabalin) waiting FDA approval. Possible med for FM?

    Glojer,
    I need the med for permanent nerve damage, my PM says he likes the topomax for headache pain but just doesn't think it works as well for nerve pain, though I have talked with a lot that have used it for nerve pain and had great results.
    I agree with you 110% about quality and not quanity, like you I also hope to be around for a long while, I just don't want it to be in pain all the time as it is my grandchildren refer to me as the grandma that hurts.
    Linda

     
    Old 09-08-2005, 06:49 AM   #10
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    Re: Lyrica (pregabalin) waiting FDA approval. Possible med for FM?

    my doctor has been telling me about this new med since last august. shes been promising it will come soon and she is all excited to give it to her patients (talk guinea pigs? lol ). she did say tho last time i was there that it wouldnt be much longer before we could get our hands on it. but, im willing to be her guinea pig on this one. ya never know. im just excited we'll be getting a chance to try something new.

     
    Old 12-11-2005, 12:14 AM   #11
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    Question Re: Lyrica (pregabalin) waiting FDA approval. Possible med for FM?

    Hi, I am on Lyrica, but it does not seem to affect the deep bone pain. It has eased some symptoms, though. Does anyone take this and other pain meds? I was on Vicodin and Flexeril through my GP, then neurologist put me on Lyrica so GP dropped the other meds. SIGH......still in pain. Suggestions?????

     
    Old 12-11-2005, 05:26 PM   #12
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    Re: Lyrica (pregabalin) waiting FDA approval. Possible med for FM?

    ive been on lyrica for about two months now or getting there. at first i thought i wasnt going to be able to tolerate the side effects. its like neurotnin. you can feel it working those first couple of days, by that i mean you can feel it going thru your blood system and your brain gets the fuzzies. it feels like little creepy feelings in there but that only lasted less than a week. it made me very sleep also during that first week or so. it doesnt anymore. i have noticed a reduction in pain and ive been on almost everything there is. im still on lortab and soma. she said to stay on it till the med started actually working . like i said its going on two months and she said i could stay on lortab and soma, just reducing the times i take it. all in all i am glad for this med since it has also helped me sleep better. it seems to have been the extra bump i needed in meds. dont get me wrong, youre not pain free even while on it, and you still get flareups, but theyre just not as severe as they have been. so so far so good. oh do have to warn you, that first week you will feel a HIGH , which i didnt care for. like i said i thought i wasnt going to be able to stay on it because of all the side effects but that goes away in one to two weeks. im happy its finally out and i do think its something else we can try. hopefully it will last and that it wont be like other meds that start off good then just stop helping.
    oh and PS. edited to include that my energy level within the last two weeks has gone up!

    Last edited by Jenetti; 12-11-2005 at 05:37 PM. Reason: to add to it

     
    Old 12-25-2005, 10:14 PM   #13
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    Re: Anxiety on Lyrica?

    I have noticed since taking Lyrica that I feel like I am going to have an anxiety attack (but only with the late day dose). I end up having to take .5-1.0 of xanax within a half hour of taking it. Is this just my weird self or have others had this experience also?
    ~Mim

    Last edited by mim; 12-25-2005 at 10:15 PM.

     
    Old 01-04-2006, 01:08 AM   #14
    junebugs granny
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    Thumbs up Re: Lyrica (pregabalin) waiting FDA approval. Possible med for FM?

    i started lyrica on dec 31, i've been on lots of pain meds and antidepressants and was at the end of my rope dealing with the everyday constant pain ,very little sleep ,went to my dr. for my thyroid update and he ask me how the latest pain med he gave me 6 wks ago was working , my reply was the same as the rest of the meds i tried no improvement , so he tells me about this new one lyrica and of course i said yes i'll try it along with another med called clona epam 1mg tablet, lyrica was given at 50mg capsul 3 times a day. it has made an improvement in my pain and i sleep longer and better, this is the first pain med that has even made a dent in the pain that was always there.i've noticed a little fogginess and i've learned not to take any meds for hrs after taking lyrica, it made me sick to my stomach, but as for helping the pain i can only say its put a major dent in mine so far and i hope it only gets better. the dr. says i have hypothyroidism, fibro, immune disorder and nerve damage. i have only been on lyrica for 5 days and can say from my personal its the best so far. wishing all a happy newyear. junebugs granny

     
    Old 01-10-2006, 07:44 PM   #15
    OraEtLabora
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    Re: Lyrica (pregabalin) waiting FDA approval. Possible med for FM?

    I was on Lyrica for only two weeks, but it did help me. Less pain, slept well, more energy. It increased the ringing in my ears a hundresfold, but I would have continued to take it anyway. I had only a two week "free trial" - and I had to stop taking it because it would have cost me $200.00/month. My insurance kicked in Jan. 1st, so I may be able to get most of it paid for now. But, my other doc wants me to try Cymbalta - I'm not sure what to do, so I'm going to take the Cymbalta for a month, I think, and if it doesn't help me, then go back and try the Lyrica - or maybe try them both.

    It used to be, there was nothing to take for Fibro - now, more choices. There is hope.

    I, too, felt a bit anxious while on the Lyrica - but that happens when my thyroid is low, too, which it was when I was on the Lyrica. So, it may have been the Lyrica, or it may have been my low thyroid, which caused the bit of anxiety.

    It will be interesting to see if any others experience anxiety while on Lyrica.

    Ora

     
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