115 replies to this topic

[Robert_Larsson]

Bad news Ironwood discontinues the development of MD-7246 after it failed the Phase 2B clinical trial assessing abdominal pain in IBS-D. I post it here since it was supposed to be developed for IBS-C and IBS-M as well. It was a DR forumlation of Linzess (linaclotide) targeting specifically abdominal pain and not motility. Given the previously weak data I was not surprised. Let's hope other treatments are more successfull.

 

https://investor.iro...-D/default.aspx

[annie7]

update on ibsrela (tenapanor) :

 

https://www.ibsgroup...s/#entry1466532

[wgbutler]

I don't know if this has been posted yet, but here is another drug that was FDA approved this year for chronic ideopathic constipation.  I haven't been able to find out if its been released to the general public yet.  Information is scarce on it.

https://www.drugtopi...tipation-adults

[annie7]

thanks.   yes, i posted here about pizensy when it was approved but yes, you're right--not much info is available about it as of yet.

[wgbutler]

thanks.   yes, i posted here about pizensy when it was approved but yes, you're right--not much info is available about it as of yet.

 

My sense of it is that it will be similar to the way lactulose works.  I tried that out and it didn't do much for the C.  Gave me horrible flatulence though, like eating 10 bowls of chili before bed.  Totally not worth whatever little good it did for the C symptoms.  My personal name for it was "flatulose".

 

I'd still like to try the pizensy out though as an experiment if it ever becomes available in prescription form.

[annie7]

oh yes, i've heard that lactulose can make people pretty gassy.  like your name for it.

 

hopefully pizensy will be available soon.

[Robert_Larsson]

4D Pharma produces medicore results in Blautix Phase 2B trial. I made a walk thorugh of the trial in case you want to read more about the context.

 

SYN-010 fails Phase 2B interrim analysis.

 

Sad news, let's hope the second tenapanor inidcation can bring it to market.

[annie7]

thanks for the update, Robert--appreciate it!

 

and yes, very disappointing news about SYN-010.

[Robert_Larsson]

@annie and wgbutler, I assume you already know this however I thought I should leave it here for others just in case:

Tenapanor (Ibsrela) has received a PDUFA Goal Date - April 29, 2021 for the Control of Serum Phosphorus in Adult Patients with CKD on Dialysis. The drug has already been approved for IBS-C in North America however it does not seem to have been picked up for production as of yet. Following more positive results in another indication a potential approval could pave the way for its entry into the North American market, which would finally provide IBS-C patients with another treatment option.

[annie7]

thanks for posting this, Robert.  

[sjw596]

I had posted this earlier, perhaps in another thread, but the manufacturer had told me that Tenapanor will not be distributed for IBS-C.  Instead, it will me marketed to treat another (more lucrative I might add) condition.  However, if something has changed, please let me know.  

[wgbutler]

I had posted this earlier, perhaps in another thread, but the manufacturer had told me that Tenapanor will not be distributed for IBS-C.  Instead, it will me marketed to treat another (more lucrative I might add) condition.  However, if something has changed, please let me know.  

Right.  They can make 4 times the money selling it to treat hyperphosphatemia (I assume this is some sort of chronic kidney disease problem) than they can selling it for chronic constipation.  CKD drugs cost about 2000 per month, constipation drugs cost 500 per month.  

I suppose if you are unlucky enough to have both CKD and chronic constipation, you will eventually be able to get the drug for the CKD condition and hopefully kill two birds with one stone.

[wgbutler]

So, a few years ago a drug Elobixibat was approved for use in Japan for chronic constipation, under the name Goofice.

Unfortunately, I have seen no evidence that this is going to be approved for the same problem in the United States.  They are trying to approve it for other health conditions in the United States, however.  I get the feeling this is the same scenario as Tenapanor, unfortunately, where no one wants to sell the drugs for constipation because they would have to sell it at a lower price than what they could get selling it for other health problems.

That being said, I found a website where you can order this from Japan.  I don't know how reputable this site is, but there doesn't appear to be anything about a prescription being required.  At any rate, the link is here:

https://bio-japan.ne...e-tablets-japan

 

[Robert_Larsson]

I had posted this earlier, perhaps in another thread, but the manufacturer had told me that Tenapanor will not be distributed for IBS-C.  Instead, it will me marketed to treat another (more lucrative I might add) condition.  However, if something has changed, please let me know.  

I don't know exactly how things work in North America in detail, but over here in Europe this wouldn't matter in most countries. As long as the drug is approved and produced a clinician can prescribe it to you, even though the company is distributing it for other conditions. The majority of drugs used have never been approved for IBS specifically and are sold for other indications, clinical consensus governs as to which drugs you can prescribe to patients. The National Board of Health and Welfare might intervene and put certain restrictions on it as to which patients are allowed to use it depending on the price tag but generally that threshold is pretty high. What the company chooses to market the drug as is seen as a pure business decision. They have no recourse to deny the prescription anyway and so the state always has the final say.

[annie7]

thanks, Robert--i agree.

 

i've taken several meds off label--one of which was misoprostol, for my constipation.

[sjw596]

Yes, that would be true, and I'd give it a try.  However, I'm not sure we can get it at the moment.  My insurance company (Navitus) doesn't list it, and neither does Costco or Walgreen's.  Perhaps someone on the forum will post back if he or she finds it.