It’s not often that you see a 1,000 person drug trial for fibromyalgia or any other disease but one recently begun in the U.S. and Canada. A Japanese drug company, Daiichi Sankyo, is making a huge bet on a new drug called mirogabalin for fibromyalgia and other diseases.
A major fibromyalgia drug trial is underway in the U.S and Canada
If mirogabalin sounds vaguely familiar it should. Daiichi Sankyo believes mirogabalin is a significant upgrade of pregabalin, e.g. Lyrica. Both drugs bind to calcium channels that have been implicated in the production of neuropathic pain.
Mirogabalin is believed to bind to a calcium channel subunit that has strictly analgesic; i.e. pain reducing properties. Lyrica, on the other hand, also binds to another subunit that has central nervous system effects that may be responsible for its side effects. Mirogabalin, Daiichi Sankyo believes will be more potent, have fewer side-effects and be longer-acting than Lyrica.
That would be a winning combination for the many fibromyalgia sufferers who either didn’t derive benefit from the Lyrica or not enough benefit to stay on it. Lyrica’s reputation for producing side-effects has become so pervasive that the company is working with researchers to try and determine what kinds of ME/CFS patients it works for and which kinds it doesn’t.
Despite the side-effect issues Lyrica has been a veritable cash cow for Pfizer. Sales reached a high of $624 million in the US in the last quarter of 2013. Pfizer, its manufacturer, was so enamored of it (and three other drugs) that for years it promoted Lyrica for uses it had not been approved for. (That little mistake left the company with a cool $2.3 billion dollar fine a couple of years ago.)
It is generic in Europe and is expected to go generic in the U.S. in 2018.
Will Head to Head Trial Topple Lyrica?
A 2014 study examining mirogabalin’s effectiveness in diabetes patients with peripheral neuropathy suggested it may indeed be more effective. In fact the short study suggested it may be 17 times more potent than Lyrica. Outside researchers have suggested that the study was marred by a short time-frame – just five weeks – that may not have allowed Lyrica to reach it’s optimum effectiveness. A recent meta-analysis of Lyrica studies, however, that most of the gains from Lyrica come in the first three to four weeks.
Will mirogabalin knock out Lyrica?
Daiichi Sankyo is clearly confident it’s struck gold with this drug. It’s begun very large, very expensive phase three trials of mirogabalin in three disorders. Two Asian trials of 750 patients in 200 centers will assess its effectiveness in diabetic neuropathy and postherpetic neuralgia. A 1,000 person U.S./Canadian trial is assessing its effectiveness in fibromyalgia.
The trial makeup – putting mirogabalin head to head to Lyrica – the number one drug for fibromyalgia – indicates Daiichi wants to topple the frontrunner and install mirogabalin as the preferred drug for FM at the same time.
The 13 week trial will test mirogabalin’s effectiveness in reducing pain and fatigue and improving sleep, mood and quality of life. It began in Oct, 2014 and is expected to last until 2017. Ninety-four study locations are present in the U.S. and Canada. Contact Daiichi using this email – SM_DS5565_FM_Info@incresearch.com – if you’re interested in being in a trial.
If mirogabalin is successful it will be the third of a family of drugs beginning with gabapentin (Neurontin) and continuing with Lyrica that have made it to market.
The success of this family of drugs has prompted drug companies to find ways to improve them. After several failures Pfizer, for instance, found that one key to the potency of this drug line is it’s ability to pass through the blood-brain barrier. Subsequently it found an analogue called 4-methylpregabalin that proved several times more potent in animals than Lyrica. Pfizer got so far behind in its search for the “next Lyrica’, though, it’s not clear if it will attempt to bring it to market. The only Pfizer funded Lyrica trial underway right now is in China.
Inquiry of the Day: If mirogabalin comes to market would you try it? Let us know here: Would You Try An Updated Version of Lyrica?
Review of the Day: Mirogabalin could replace Lyrica and Neurontin. How have you done on those drugs? Let us know here:
- Lyrica – http://healthrising.org/forums/reviews/treatments/pain/lyrica-pregabalin.186/
- Neurontin – http://healthrising.org/forums/reviews/treatments/pain/neurontin-gabapentin.185/
I would try it. Lyrica helped some but not enough to put up with side effects.
If this is anything like the old Lyrica, you could not pay me to take it. Pure poison for many of us!
I agree with it being pure poison. I felt like my head would explode & I would die. It was the first time in my life I thought I was going crazy.
wow, huge trial. Thanks for the news update. Looking forward to the day something similar happens for ME/CFS.
🙂
My experience taking Neurotin 18 years ago was one of the worst experience of my life. Although it initially allowed me to sleep (I suffered from severe insomnia at the time) and stopped my food reactions I gradually built a tolerance to it. Increasing my dose was only helpful for a short time. After 6 weeks I discontinued taking Neurotin altogether. Then the nightmare began – a horrific withdrawal experience even when gradually decreasing my dose, which caused severe suicidal depression, anxiety and full blown insomnia with night sweats. The withdrawal symptoms lasted for 6 months and finally subsided by doing intensive neurofeedback training. I know others who had similar withdrawal symptoms – a side effect that is not disclosed to most patients. As a result of this experience I have avoided pharmaceutical drugs. Eventually I did find therapies to reverse both chronic fatigue and fibromyalgia which you can read about on my blog fibrofriends.typepad.com. In my humble opinion there will never be an effective drug to treat CFS or FMS, and one will eventually pay the piper for taking drugs that try to dampen symptoms.
Wow! Gotta be real careful with these drugs.
I am on Lyrica 600mg a day been on these just over a year now, apart from putting weight on they take the edge of pain,depending on how bad im feeling… I am very eager to keep an eye on this trial.. I would take it as long as my doctor would prescribe them/
Sal, that is a high dose. I only take 100
Mg a day now and feel drowsy a lot. Are you doing okay with it? I will definitely try the new drug if given the opportunity.
No- am allergic to lyrica- and that class of drugs- wouldn’t risk it- it caused my face and head to swell after3-4 days- not worth it.
Thanks for info, Cort, just wrote asking for info re open label extension trial. Interesting thinking about whether I’d rather be in a low vs. hi dose vs. placebo 13 week study or a low vs hi 52 week study looking for adverse effects. I think you probably have to give up alcohol for this study….
Good luck Steve.
No, not unless there was evidence that it would not cause weight gain. I have high inflammation because of Lupus and the extra weight against my muscles and joints produced more pain than it helped. The only thing it helped was the neuropathy in my feet and I’ll take Metanx for that instead of Lyrica.
when put on lyrics ihadswolen face and throat and was paralyzed on the left side two days! On neurontin now refusing to take more than a morning and evening pill. if I take more
Both legs have continual spasms and cramps!
Definitely not the intended outcome!
I think they have the correct approach trying to work on the CNS. I don’t like the approach of Dr. Pridigen for Fibro, I think it is an ME/CFS approach and I have to wonder what his diagnostic criteria is. Many may be ME/CFS patients or Fibro and ME/CFS and that is why his drug combo for viral and inflammation is helping them. Or even RA patients with low D.
That is the problem I have with Pridigen, without being able to see the study, diagnostic criteria and so on I don’t trust his work.
hi Sue,
I had been reading so much about the Valtrex, celebrex combination that I talk to my doctor into letting me try it!
Of course it was too expensive and my insurance wouldn’t pay so we had to get pre-approved for the generic versions.
Apparently, it takes about 3 months for the effects to start and I have only been on it one month.
My question to you… Is why don’t you trust Dr Pridgen?
Any particular reason?
Have you worked with him or been a patient in the past?
I’m just a little concerned because valtrex seems like such a strong medication to me…
When I click on the lyrics and neurontin links to state my experience with them, it takes me to site but with a message that the page can’t be found.
I had the same problem. That is really weird…but I’ve had problems with links into the Forums before. Here they are – I hope you can get your review in there 🙂
Lyrica – http://www.cortjohnson.org/forums/reviews/treatments/pain/lyrica-pregabalin.186/
Neurontin – http://www.cortjohnson.org/forums/reviews/treatments/pain/neurontin-gabapentin.185/
I would try it if the side effect did not include weight gain and inflammation. I am currently taking Gabapentin 1800 a day. I have gained 30 pounds in 2 years, not to say it was all medicine related, but it has been very difficult to impossible to lose it. Inflammation in legs, ankles, and forearms is due to the Gaba and I have not been able to get rid of that either. So, yes, I would try the new med especially if it helps with neuropathy and doesn’t cause weight gain.
Hopefully it will not have those side effects – that’s certainly one of the goals.
Low level doses of Gabapentin are fairly effective for me.
Lyrica made me a nut case.
The drugs I use to become normal are
200 mg Armodafanil
60 mg Tramadol
2 mg Clonezepam
All taken at the exact same time daily. I get about 7 hours of productive time.
I take antiviral drugs during the rest of the day, but never when I wake up.
Congratulations on finding a good and interesting treatment regimen: a stimulant, a pain reducer and an anti-convulsant. It looks like you’re stimulating one part of your system and toning down another. Somehow that makes real sense to me. Thanks for sharing that.
How interesting that Neurontin and Lyrica could have such differing effects..
I would try it even if the possible side effect was being alone in the universe. Any chance of getting it off label, out of studies?
(I wonder… Perhaps Ldn is already the most strong drug and with less side effects but there will never be a billion dollar study like this one…)
I would totally try it. Lyrica made gain weight. Now I’m on cymbalta and can’t tell a difference. I would love to try it.
I hope it works out and you get the chance. 🙂
There are receptor sites all over the body for endorphins and enkaphlin receptors that regulate the pain response. From treating Lyme disease, the Jarisch-Herxheimer reaction has often looked to me like a heroin withdrawal syndrome — that includes muscle pain, and many of the symptoms we associate with CFS and this disease spectrum.
The answer seemed obvious to me: could the chronic infections be stirring up pro-inflammatory molecules or toxins that BLOCK the receptor sites for endorphins or enkephilins, that would essentially cause someone to look like they are withdrawing from their own endogenous MORPHINE (i.e., endorphin).
A molecule could competitively bind to a receptor site, blocking the molecule that would normally sit there and activate the receptor. Instead, it is blocked — and the person experiences pain, pain, pain seemingly for no reason.
Interesting idea! Intuitively it makes a lot of sense.
Interesting. How would you think that LDN is purported to work?
I had memory problems with Lyrica. I am having success with another treatment. I would not switch. It would have to be a lot cheaper for me to give it a try. But I’m sure it will be just as expensive.
Thanks Pamela – can you say what’s working with you?
And the BIG P lied. They are currently being sued for false claims and under-reporting of their study results. I tried it, when in pain we will try just about anything. I had a life-threatening reaction. Anything that causes the body to swell, and it’s okay to say, wait until your body gets used to it is reason for suspect. My body did not get used to it, instead the symptoms escalated. Being the good patient, I gave it my go and could have cost me my life. So, a new drug? More powerful than Lyrica (T), not sure I would try it and unless this company has pharma reps in the US, we might not hear much about it. The proof, unfortunately, will be in the pudding, after it gets FDA approval and is consumed by the masses, the real experiment.
Lyrica, neurotic, gaparatine are all the same drug. Just stronger. And, NOT approved for off label use. Lyrica almost killed me a yr ago. There’s not enough money in the world to get me to try the “new” stuff. I’m finding different ways to handle my pain.
I agree. My awful reaction was reported to the FDA by my Dr. & myself with no response. I wonder if they are recorded.
The mirogabalin folks got back to for my zip code for the 52 week adverse event trial. I’m somewhat familiar with the FDA trial system and I don’t remember other meds doing Phase 3 trials for long term adverse events. Does make me wonder if some really bad things cropped up in their trials?! Usually, I find out adverse events after meds come out by monitoring their websites, where low frequency but significant problems gradually get posted. I don’t want to sign on any dotted lines without a good discussion with these folks first. I know you can leave a study but having to leave because something awful happened to you is not good.
I would ask them about that. It could also be that they’re really confident about the drug, I suppose. It would be interesting to hear what they had to say.
Ok, I just spent time talking to the FM mirogabalin study folks. I would qualify but it would be tough. My take is that you will have to be a hardy soul to volunteer because a lot of meds that get me through the day are excluded, probably with a week washout period before you actually start the study. No Ambien, melatonin, sedatives, or sleep meds, no pain meds like Tramadol. You don’t get to to enter the 52 week 15 mg vs. 30 mg adverse event trial until you go through the roughly 15 week double blind placebo vs. 15 vs. 30 study. So this study is essentially excluding people with severe insomnia, a pretty good hallmark sx for us fibies, because we couldn’t make it through the trials without a sleep med. Maybe you take the med at night and it makes you sleepy but if you are on placebo you are screwed. I don’t see how I could make it through the study which, of course, you can bail from. I’ll report any other nuances when they email the extensive consent form. I was kind of afraid of this.
I have just completed the 15 week trial I have Fibro. It was the hardest 15 weeks of my life. I havent slept and been in agony without any pain eds, plus the addition of a torn tendon which I could not receive treatment for. I have just been rolled over into a 52 week open label trial of Mirogablin. After 7 days nothing has improved no sleep and lots of pain still without being able to take anything except panadol (like that would make a difference). I have started getting itchy and last night went through a period of time of feeling uneasy. I have been told by the hospital this morning if the feeling doesnt stop I am to stop taking the drug immediately.
Jeez, Julie, you have my admiration and best wishes, as well as Honey above. I hope the med starts working for you. People who take prescription meds forget at what personal cost they were tested and approved by people like you. Clinical trials are for the desperate, a group in which I include myself but I didn’t have the resilience for the study. Let us know how it works out for both of you.
As for Tramadol, I told my “pain specialist” that you could take Tramadol and still be in excruciating pain. She said “I know”. Then she said up the dose. NFW. I’m waiting, forever it seems, for the right strain of high CBD MJ to appear in a legal dispensary and drive 8 hrs RT for it and very small samples of five others strains, to make tinctures of each and see if any works. I’m also starting yoga, found to reduce pain some folks in a 2010 study with good f/u.
Good luck again fellow fibies.
I have been on Lyrica for about 9 months now, and it has been a godsend for me. I can finally sleep at night, and I don’t feel the widespread aches throughout my body, and horrible neuropathic pain. Alas I am slowly building up tolerance as my body returns to homeostasis, but to be honest, I am thankful for however long it gives me relief. :-)(Diagnosed with me/cfs 5 years ago).
Glad to hear it Mel.
Cort, Leslie hear from Denver. I have been reading about the Wallace Fisher Stimulator for pain, insomnia, depression and anxiety. It is FDA approved and been around a number of years. Have you ever heard of it or any of your readers out there. My sleep doctor is going to research it for me next week. It looks great and got good reviews. It is pricey for those of us on Medicare but like everyone says it is works any amount of money would be worth relief in any of the 4 areas.
I have tried Lyrica, and although it did control some of the pain, the side effects were horrendous. I have sleep problems anyway because of drugs (I am currently on Fentanyl, Paracetamol, Gabapentin and Meptid). I was on Lyrica in place of Gabapentin and it definitely controlled the pain better however I was falling asleep during the day, and I flake out in the evening anyway, but Lyrica made this a lot worse. On a positive side, if you could get to bed early enough and didn’t have to get up early, you may benefit through better sleep, as it was quite deep sleep, but I was waking up at 7.00 am having fallen asleep on the couch the previous night, with muscles aching even more than usual. Had to come off it eventually. I did not get used to the symptoms. Even though I was on the maximum dose, the symptoms started at a relatively low dosage and didn’t really get much worse.
I would definitely try the new drug, but if they don’t finish the US trial until 2017, then have to get FDA approval, then approval in Europe, UK citizens will be lucky to get it in 2022, because we have an organisation called NICE that has to approve all medications on value for money because the National Health Service is not permitted to buy drugs that are not considered to be of significant benefit.
I have been on Lyrica for quite a while having tried most of the other drugs
on offer. I am on 450gms and, apart from weight gain, it has been an invaluable drug helping me a great deal. I am so sorry for others who have struggled so much.
Glad to hear it Corrinne. When this drug works it really does work. It’s unfortunate it doesn’t work more often but hopefully the next iteration will.
I had lots of side effects with Gabapentin so switched to Lyrica. Severe side effects with Lyrica. Serious enough that I list it as a medication allergy. I would be very hesitant to even think about taking another medication in that category.
Lyrica essentially works the same way as Gabapentin but is stronger (that was my experience anyway). I was the other way round; I had problems on Lyrica so I am currently on Gabapentin, with less side effects but in more pain.
We refer to lyrics as the awful poisonous suicide juice at our house. I wouldn’t take it again ever
Hey there fellow sufferers.. I am doing this trial but won’t actually get the pill started until next week. It’s been very rough the past few weeks weaning off of all my other drugs. Insomnia has been excrutiating so please say a prayer that I dont get the placebo next week! I dont think I could make it another 13 weeks in yhe state im in right now. I will try to keep you all posted on how things go for me. Here goes nothing!
Good luck with it! I hope it works out for you.
Good luck, Honey. You are way tougher than I am. I interviewed for that one but knew I couldn’t get off meds for 13 weeks so declined. Then they sent me a birthday card LOL.
Honey, thank you for participating in this trial. If it works to help Fibro patients you will be saving all of us from pain and sleepless nights. I hope you do not get the placebo.
Lynn N.
I had mentioned I bailed on that. Honey, again, you have my admiration and best wishes! I also hope you get the med, my guess is that you will know quickly given that med profile. Worst case scenario…tolerate 13 weeks of placebo and they give you the med. Will cross my fingers it goes the other way first.
Good luck, Honey. You are way tougher than I am. I interviewed for that one but knew I couldn’t get off meds for 13 weeks so declined. Then they sent me a birthday card LOL.
Well that was nice! The withdrawals from Cymbalta are crazy! I literally mran crazy, like I feel I should be committed some days. I sure hope it’s worth it.
That’s awful Julie! I just started this trial and it’s only day 3 of med. No difference yet. I really don’t need a sugar pill right now. If I were you though I would stop taking it especially if it’s not even helping. Best wishes and take care!
Just started Lyrica. 200 mg a day. Find it helps with the pain “on the fringes”…but not the mid to deep pain. I have gained 4 pounds and get a little brain fog a bit after taking it…but the fog is not really bothersome and does not last. However; concerned about the weight gain. My bones can’t handle, nor do they need much more weight. What has been your experience with weight gain? Does it subside or do you keep gaining?
Hello
I am in the UK and am one of the few people here that is prescribed pregabalin for fibromyalgia. On most of the fibro of forums you mostly see people bemoaning the side effects (not that I’m suggesting they are not real for some people) but mine is a success story. It hasn’t been a miracle drug but compared to others or no drugs at all, it has given me my life back and I am now able to work full time again in a rewarding and stimulating job, though I do find it very tiring. I have if anything lost weight as I am more active. It has helped a lot, over time, with the cursed brain fog. The only side effects I experienced was a feeling of being slightly drunk in the first week that wore off far too soon. However, I do find I can’t STOP taking it, as I get really ill very quickly. though I do find I can reduce and increase the dose as I see fit. I also use cannabis and find it helpful with pain, and don’t object to the other effects. I’ve just signed up for a clinical trial of microgabalin, which looks like it may be a promising successor to pregabalin.
Great to hear a success story Laura! The studies suggest that people are getting help from this drug but we don’t hear enough of it. Thanks for relating your experience and good luck with the mirogabalin!
Hi Laura , I am in Cornwall UK and have just gone through the screening process for the new drug trail https://clinicaltrials.gov/show/NCT02234583
I’m happy to keep in touch if you ever fancy a chat about it .. It’s pretty scary but if it work it would give me some of my life back .. I’ve been ill for three years now and had enough !
Anyways take care 🙂
Hi Laura I’m in Cornwall il and I have just gone through the screening process for the trial and happy to correspond with you via email if you like just to support each other ! 🙂
Hi Sarah, thanks for the link for clinical trial. I’m in the UK too and would like to register for this trial. Where do I go to register? Couldn’t find a link.
My 91 yo mother is on Lyrica 100 MG 3 x a day long term. She is in the hospital over two weeks now because at beginning of week two the Dr decided she should go off Lyrica cold turkey for some unknown reason. My mom crashed into a catatonic state and exhibited dementia (she is not). It took 3 days before a family member suggested checking her Lyrica and discovering the problem. Two days back on Lyrica and she is back ok. These drugs create a house of cards in your nervous system. Avoid at all possible and if you are taking it, you need to taper off.
And yes I filed a formal complaint at the hospital about this doctor who apparently does not read the PDR.
I’m at the halfway point for the doubemblind study. So far, the effects I’ve found are an increase in insomnia, and taking the edge off my pain. I’m not sure what I’m on, I think it may be either the Lyrics or Mirogabelin. As an already overweight woman, it was very frustrating to gain another 12 lbs but if that’s the worst side effect, I’m good with it. I’m entering the tapering off section and then the open label. So glad I haven’t had to take a lot of other meds. I knew something was going on, but between insurance troubles and being on a fixed income (I’m 63) I didn’t see a doctor and have just taken up a major residency on my couch (which I really hate). Hopefully I can regain a little oomph back.
Thanks for comments, DB. I couldn’t do trial good luck and keep us informed.
guys, the secret is to not take it every day. i skip 2 days and have been on the same dose for 5 months. worked wonders for my social anxiety. don’t listen to your doctor on how to take it. experiment and discover how it will work with you. but i gotta admit the withdrawal is pretty bad and annoying. after you discontinue just hit the gym. really looking forward to mirogabalin.
Wow,
Waleed, I’m not sure Lyrica is indicated for social anxiety but if it works for you, I guess…
I’m finding it to be an unpredictable med for fibro nerve and other pains, with unpredictable side effects also, while taking 50 mg t.i.d. I have a three week trial before I see the doc and report, hope it become clearer to me.
UPDATE: I’ve completed the first study and have opted to stay on for the 52 week trial! This stuff has been amazing! I feel like I have control in my life again. I’m sleeping so well at night too. Aches and stiffness are almost completely gone. Nerve pain very seldom and very mild. The only side effect might be some irritability. I seem to be short amd snappy at times. Thank goodness my family loves me. My blood pressure is back to normal again since this 1 med is replacing 4. I just cant say enough good things about it and can’t wait to see my rheumy in a few weeks! Best wishes and take care all!
Wow, that’s great,congratulations, wish I’d signed up but might have gotten placebo! Let us know the name of the med when they tell you.
I just started Lyrica, the precursor, last week. I can think of a bunch of side effects the new med can hopefully drop.
I have chronic fatigue syndrome officially diagnosed in 2014 after 3 years of suffering. I have Nero borreliosis since 2008 which was improperly treated at the time with an insufficient dose of antibiotics as it was really treated by accident after I had acute appendicitis. The infection must have occurred about a week after the appendicitis when I had just finished the first lot of antibiotics. I was infected in Germany only days before returning to Australia got the bullseye rash in Australia and nobody knew what it was however I was prescribed a new lot of antibiotics in hospital GTD acute appendicitis that I experienced marlin Europe.
In 2011 I started getting the most horrific diarrhoea muscle pains skin rashes joint pains brain fog extreme sweats day and night that would not respond to any treatment. I tried Lyrica 150 mg as one of the last resort for the pain over experienced and nothing happened at month 15 mg some months later after months of suffering not being able to leave the house excruciating pain and sweats I attempted Lyrica again at 300mg as nothing else helped the pains throughout my whole body. Within 2 hours of taking the Lyrica my stools will normal the switch disappeared the pain disappeared I had no brain fog with it whatsoever anymore and felt like a human being for the first time in some 3 years.
I ended up with a daily dose of 600 mg at first, then the symptoms ie Pain and brainfog returned somewhat and I started taking 2 x 600 mg a day for some months. I never experienced any negative side effects from Lyrica When I took it, nor any major withdrawals when I decreased the day or even ran out. I have reduced my daily dosage to 2 x 300 mg a day, this helped managing most of my symptoms since 2013 being mostly symptom fre, although on some days. diarrhoea and brain fog and muscle aches (myalgias) returned. I am on holidays in Europe and about 2 weeks ago I ran out of Lyrica. Although I had no withdrawal symptoms, my other symptoms I:e. diarrhea myalgias returned.
I again attempted to get a doctor to test my spinal fluid for borrelia as it was here I was infected in 2008 resulting in the bulls-eye rash. I have been unable to find a doctor Who is prepared to do a lumbar puncture 4 testing my CNS floor for the presence of spirochetes due to the danger of this procedure. I started taking Lyrica again and within a matter of hours I felt well. However now I’ve 2 days of lyrica, all the symptoms that are normally associated with an immune response I. E. flu like symptoms, I have returned with the Vengeance. I can only Connect this pattern with Lyrica somehow effecting the spirochetes of the borreliosis leading them to die and creating the immune reaction as my gut is functioning perfectly right now. Has anyone ever experienced any kind of herxheimer reaction as described above when taking Lyrica ?
Has anyone ever experienced for diarrhea to disappear almost immediately upon taking Lyrica? What effect did you experience Lyrica to have in regard to your microbiome?