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Discussion Starter · #1 ·
Given that the FDA approved Ibsrela about a year ago, I assumed it was available in the U.S. According to my insurance company, its not. They agree that its approved, but not yet available (hence covered) here. Is that correct? Thanks.
 

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yes, i assumed it was available here in the usa, too.

have you tried calling your pharmacy and asking them?
 

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that seems really odd, that it was approved such a long time ago and not available.

hope you get an answer from the manufacturer. if you don't, you could try calling them. a lot of drug manufacturers have customer service numbers you can call.
 

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Discussion Starter · #5 ·
Thanks. The web site doesn't list anything other than an online form for info, which I sent to them. I also sent a direct email to their media contact. Will advise if I hear anything, I haven't noted any users on the forum.
 

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Discussion Starter · #7 ·
Well, it's not good news:

I'm responding to your question below regarding Ibsrela (tenapanor). Ardelyx will not be commercializing Ibsrela in the U.S. market. If a U.S. commercial partner is identified and a licensing deal is struck, Ibsrela could be launched in the U.S. If this does not happen Ardelyx has no current plans to commercialize Ibsrela. We are currently seeking a second indication for tenapanor for the treatment of hyperphosphatemia in CKD patients on dialysis. If approved, Ardelyx fully intends to commercialize tenapanor in the U.S. (obviously under a different brand name) for this indication.
 

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thanks.

you're right--not good news.

i managed to find a phone number ( 510-745-1700) for ardelyx and called them just now and the guy who answered told me the same thing.
 

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I read an article several weeks ago which explained what is happening. The reason why they are not making it available in the United States is because they are going to get the same drug approved by the FDA in a year or so to treat hyperphosphatemia.

Drugs that treat hyperphosphatemia typically sell for 1600-2000 for a month's dosage. Drugs that treat chronic constipation typically sell for around 300-500 per month. If you were Ardelyx and had just invested millions to develop the drug, which condition would you rather sell it for? If they sell it for constipation then what would happen is that doctors would prescribe it off-label to treat hyperphosphatemia and they would miss out on a ton of money.

So it kind of sucks for the chronic constipation sufferers. The only way to get this will be to get diagnosed with hyperphosphatemia and have the doctor write you a prescription for that. I suppose if you are unlucky enough to simultaneously suffer from both chronic constipation and hyperphosphatemia you can get your hyperphosphatemia doctor to write you a prescription for it and kill two birds with one stone, so to speak.

This isn't the article I read, but here is them filing the drug with the FDA to treat hyperphosphatemia:

https://www.medthority.com/news/ibsrela-filed-with-fda-for-hyperphosphatemia-in-adult-patients-with-chronic-kidney-disease-on-dialysis.--ardelyx/
 

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wgbutler! so good to hear from you again! how are you?

thanks so much for this information! unfortunately it makes perfect sense. what a shame that we lost a C drug,
I'm doing ok. Basically the same.

I've started to see a new GI who practices medicine pretty far away from where I live. It's Dr. Satish Rao in Augusta, GA. He's kind of an expert on pelvic floor outlet dysfunction which is what I think I have, because all of the tests they've run on my intestines have been normal.

So he's going to do a whole lot of other tests on me and give me a diagnosis, and if it ends up being Type 1 PFD, he's going to treat me with biofeedback therapy.

I basically get through the days by taking Metamucil and Miralax every day, which usually helps me evacuate enough to get through the day. Sometimes when things get really bad I'll take a Trulance which usually provides extra relief by giving me 3-5 hours of severe D. It's a very unpleasant life.

On top of that I'm starting to suffer from osteoarthritis in my hands, knees, and neck. It's like the next level of hell when you combine that with the chronic constipation.

How are you doing?
 

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BTW, Dr. Rao is one of the research doctors investigating the Vibrant Capsule. I tried to get in on that clinical trial but I got kicked out because I wasn't constipated enough. Which is bizarre because I'm pretty darn constipated. I can't imagine how people get by who are even more constipated than me.

I asked him about the Vibrant pill and he said it might help me, but it typically helps people with motility issues (the kinds of C that drugs like Motegrity help by speeding up the large intestine and colon, etc). Maybe someday it will be released and I'll get a chance to try it out.

A study was recently published on the latest trial which you can read here:

https://onlinelibrary.wiley.com/doi/full/10.1111/nmo.13890
 

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that's good that you are seeing a new GI who's an expert in pfd. good luck with your tests. i was dx'd with pfd and did a couple courses in biofeedback. i even bought a home biofeedback machine so i could practice every day at home.

so sorry about your osteoarthritis. i remember you mentioned that before. hope it hasn't gotten worse. yes, it's a miserable thing to live with. i have it too. did you ever get a chance to try voltaren gel (diclofenac sodium topical gel) ? it does help somewhat. i rub it all over my knees, back of my neck and fingers. it's OTC now--not a script--so it's even easier to buy.

wow--that's amazing that you were kicked out of the vibrant clinical trial---not constipated enough??? they gotta be kidding. but yes, i can see that it would help people with motility issues more than people with pfd.

good luck with everything. hope that somehow you can find some relief. take care.
 
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that's good that you are seeing a new GI who's an expert in pfd. good luck with your tests. i was dx'd with pfd and did a couple courses in biofeedback. i even bought a home biofeedback machine so i could practice every day at home.

so sorry about your osteoarthritis. i remember you mentioned that before. hope it hasn't gotten worse. yes, it's a miserable thing to live with. i have it too. did you ever get a chance to try voltaren gel (diclofenac sodium topical gel) ? it does help somewhat. i rub it all over my knees, back of my neck and fingers. it's OTC now--not a script--so it's even easier to buy.

wow--that's amazing that you were kicked out of the vibrant clinical trial---not constipated enough??? they gotta be kidding. but yes, i can see that it would help people with motility issues more than people with pfd.

good luck with everything. hope that somehow you can find some relief. take care.
Thanks Annie. You are so kind. I consider you to be a true friend.

Regarding the OA in my hands, neck, and knees. I've tried pretty much every NSAID out there, including the Voltaren gel, which I have dozens of tubes of. They do seem to help to a degree. The latest one I just tried yesterday, Celebrex, and I felt considerably better all day long. Very little pain and stiffness. I don't know if that was just me having a lucky day or if it will consistently provide better relief than the other NSAIDS. Time will tell.

I've also tried Arthrotec which is a combination of Misoprostol and Diclofenac in oral form, hoping that the Misoprostol would also help with the chronic C. Didn't notice much help with the C, and with the OA it helped some, but not a whole lot.

I just don't know how safe it is to take these types of drugs on a long term basis (although I think the Voltaren gel is safe to liberally use long term since its a topical medication and is generally localized to the treated area.) I don't want to destroy my liver, kidneys, or damage my heart. So I try to limit them to times when I'm in a real bad flare and just get by with natural remedies the rest of the time.

I suppose eventually I could get fusion surgery for some of my fingers and total knee replacements if things got worse. Right now I am able to still get by and function for the most part, although I suffer with a lot of pain and stiffness.

Believe it or not, i consider the OA to be a worse problem than the constipation. At least with the constipation I can always load up on laxatives or just not eat for several days when I need a break. With the OA there's really not a darn thing I can do about it and every morning I wake up with a ton of stiffness which lingers through a good part of the day.
 

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thank you for your kind words. i consider you to be a good friend as well.

that's good that you started celebrex and had a good day yesterday. hopefully it will help you long term. maybe i should switch to celebrex. i'll been taking aleve (for arthritis and for my migraines) but it's made my acid reflux worse.

that's interesting that you tried arthrotec. i've never heard of it; thanks for mentioning it. i tried misoprostol for my constipation. it gave me lots of diarrhea so i eventually stopped taking it.

have you tried hyaluronic acid (supartz etc) shots for your knees? i was getting them for several years and it did help but then my insurance stopped paying for it so i had to stop getting the shots..

i did go to physical therapy for my knees and neck. it helped a little.

yes, i agree with you about OA being harder to deal with than C. it's all the pain. i'm just not good with pain. and yes, the morning pain and stiffness. not good.
 

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thank you for your kind words. i consider you to be a good friend as well.

that's good that you started celebrex and had a good day yesterday. hopefully it will help you long term. maybe i should switch to celebrex. i'll been taking aleve (for arthritis and for my migraines) but it's made my acid reflux worse.

that's interesting that you tried arthrotec. i've never heard of it; thanks for mentioning it. i tried misoprostol for my constipation. it gave me lots of diarrhea so i eventually stopped taking it.

have you tried hyaluronic acid (supartz etc) shots for your knees? i was getting them for several years and it did help but then my insurance stopped paying for it so i had to stop getting the shots..

i did go to physical therapy for my knees and neck. it helped a little.

yes, i agree with you about OA being harder to deal with than C. it's all the pain. i'm just not good with pain. and yes, the morning pain and stiffness. not good.
I haven't tried the HA shots for my knees yet. That's next on the docket. My insurance won't pay for it unless my knee doctor tries the corticosteroid shots first and determines that it doesn't help. I tried to start with the HA shots first because I've read that steroid shots can degrade the joint over time, but insurance said no dice.

So I had the steroid shot a few months ago. It hurt like crazy the first 4 or 5 days, I was barely able to walk. Then my knees felt a bit better, now they feel the same as they did before I had the shot, so I don't think I'm going to get another one. But I will ask the doc to do an HA shot next time, especially since that doesn't cause long term damage. After that I might save up some money and get PRP for the knees. My goal is to try to make my knees last at least five more years to buy myself as much as time as possible before I get any knee replacements. The knee replacements are getting better every year, so time is kind of on my side there.

I took another Celebrex today. It definitely helps with the stiffness and pain, but I wouldn't call it a magic bullet. Stiffness and pain are still there, and I didn't have quite as good of a day today as I did a few days ago, so maybe that was just me having a better than average day. I'll keep taking it for a few more days to see if I notice any sustained improvement of my symptoms.

Regarding Arthrotec, the reason why they mix Misoprostol and Diclofenac Sodium in the same pill is because the Misoprostol is supposed to provide some kind of protection against the GI distress of the NSAID, but it has D as a side effect. Which for a person like me is a good thing because that helps me go. But I didn't notice much improvement with the C when I was taking it TBH.
 

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i've never had steroid shots. and, yes, i've heard that too about steroid shots--that they can degrade the joint over time. plus i have chronic insomnia and am concerned that a steroid shot will just make it worse. my back doctor offered me corticosteroid shots for my sacroiliac joint but i didn't get them because of that.

good luck with the HA shots when you get them. they did hurt a bit when i got them but they were effective.
 

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i've never had steroid shots. and, yes, i've heard that too about steroid shots--that they can degrade the joint over time. plus i have chronic insomnia and am concerned that a steroid shot will just make it worse. my back doctor offered me corticosteroid shots for my sacroiliac joint but i didn't get them because of that.

good luck with the HA shots when you get them. they did hurt a bit when i got them but they were effective.
I haven't tried the HA shots for my knees yet. That's next on the docket. My insurance won't pay for it unless my knee doctor tries the corticosteroid shots first and determines that it doesn't help. I tried to start with the HA shots first because I've read that steroid shots can degrade the joint over time, but insurance said no dice.

So I had the steroid shot a few months ago. It hurt like crazy the first 4 or 5 days, I was barely able to walk. Then my knees felt a bit better, now they feel the same as they did before I had the shot, so I don't think I'm going to get another one. But I will ask the doc to do an HA shot next time, especially since that doesn't cause long term damage. After that I might save up some money and get PRP for the knees. My goal is to try to make my knees last at least five more years to buy myself as much as time as possible before I get any knee replacements. The knee replacements are getting better every year, so time is kind of on my side there.

I took another Celebrex today. It definitely helps with the stiffness and pain, but I wouldn't call it a magic bullet. Stiffness and pain are still there, and I didn't have quite as good of a day today as I did a few days ago, so maybe that was just me having a better than average day. I'll keep taking it for a few more days to see if I notice any sustained improvement of my symptoms.

Regarding Arthrotec, the reason why they mix Misoprostol and Diclofenac Sodium in the same pill is because the Misoprostol is supposed to provide some kind of protection against the GI distress of the NSAID, but it has D as a side effect. Which for a person like me is a good thing because that helps me go. But I didn't notice much improvement with the C when I was taking it TBH.
It's available now

Ibsrela Now Available for Irritable Bowel Syndrome With Constipation (empr.com)
 
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