115 replies to this topic

[wgbutler]

This is awesome!  Wow!  In a short amount of time we should have three new drugs available for IBS-C and CIC (Tenapanor, Prucalopride, and Zelnorm).  I'm glad that the market is finally responding to this problem with lots of different options!

Here's a link on Tenapanor:

https://www.mdedge.c...irritable-bowel


I have my eye on two other drugs on the horizon as well, Velusetrag and SYN-10. 

Velusetrag is a drug like Prucalopride and Zelnorm, and has shown promising results for gastroperisis and constipation:  

https://www.ncbi.nlm...pubmed/27269187

https://www.tandfonl...rnalCode=ieid20

SYN-010 targets methane producing bacteria in the gut, preventing them from creating methane which is apparently a cause for slow intestinal transit and chronic constipation.  It's currently going through a phase 2B clinical study at Cedars-Sinai Medical Center:
 

https://seekingalpha...dy-synminus-010


 

It's probably going to be some time before these make it in but hopefully within the next 5 years.

[annie7]

yes, that's terrific that people will finally have some more options!  Finally!!

 

i've been watching Velusetrag since they first started developing it because it's a selective 5-HT4 receptor agonist like zelnorm.  i do hope they are still working on  developing it it as a C med.  all the reports i've read on it recently (in the last year)  mentioned that they were developing it as a med for gastroparesis. 

[wgbutler]

Here's are more articles discussing the FDA Panel approval of Zelnorm and Prucalopride:


Before it was approved:
https://www.medpaget...lsyndrome/75739


 

After it was approved:

 

 

 

https://www.medpaget...lsyndrome/75810

[wgbutler]

Elobixibat was approved for use in Japan earlier this year and is apparently doing very well.  So hopefully it will make its way to the United States before too long.

https://www.thepharm...ic-constipation

[annie7]

well it looks like back in 2013 they were running clinical trials on it here but the study was terminated due to distribution issues:

 

https://clinicaltria...how_locs=Y#locn

 

there was another study too:

 

https://clinicaltria...how/NCT01007123

[annie7]

there is also the vibrant vibrating capsule.

 

https://www.healio.c...ic-constipation

 

 

 

https://www.ibsgroup...le#entry1187186

[wgbutler]

there is also the vibrant vibrating capsule.

 

https://www.healio.c...ic-constipation

 

 

 

https://www.ibsgroup...le#entry1187186

 

 

 

The Vibrant Vibrating Capsule?  That sounds like a magical artifact in a role playing game!  And all I can say is WOW.  This could be absolutely perfect.  A device with no chemicals and NO SIDE EFFECTS that causes you to have normal peristalic waves!  That's ingenious!

 

I just wonder how expensive this would be.  Not knowing anything about it, it seems to me like it would be a small mechanical device with its own power source and would be quite expensive to produce in mass quantities.  And obviously, it wouldn't be easily reusable (not that anyone would WANT to reuse it, that would be very gross!).

 

Stuff like this really gives me hope that by the time I'm an old man, this problem will just be a minor inconvenience well managed with modern medical therapies.

 

https://www.usatoday...apsule/8513473/

 

 

https://www.digitalt...l-constipation/

[annie7]

yes, i would think that the vibrant capsule would be very expensive.

[wgbutler]

According to this meta analysis of various secretagogues, Tenapanor is the best at reducing bloating and has less adverse effects than linaclotide or trulance. Its probably not quite as efficacious, but it still may be plenty good:

https://www.ncbi.nlm...ubmed/30144426/

[annie7]

update on tenapanor:

 

 

 

https://www.prnewswi...-300748969.html

[annie7]

another update on tenapanor--scroll down to "Tenapanor for Irritable Bowel Syndrome with Constipation (IBS-C)

NDA accepted for review with PDUFA date September 12, 2019" :

 

https://www.ardelyx.com/what-we-do/

[sjw596]

I thought I'd give this thread a bump to ask whether someone who knows more about the current status of the new drugs awaiting approval could post a very brief summary of where each drug is in the pipeline.  I've looked around, and it seems that some of the target dates have passed.  Thanks!

[wgbutler]

I thought I'd give this thread a bump to ask whether someone who knows more about the current status of the new drugs awaiting approval could post a very brief summary of where each drug is in the pipeline.  I've looked around, and it seems that some of the target dates have passed.  Thanks!

 

 

Well supposedly Motegrity is going to be released in the first half of this year.  I'm so ticked off at Shire.  The drug has been FDA approved since December 2018 and they haven't launched it yet.  Seems like I've been waiting forever to try this drug out and I'm sick and tired of taking the secretagogues which give me horrible D.  I don't understand why its taking so long considering that they have been selling this drug in Canada and Europe for years.  Its not like this a brand new drug.

 

Tenapanor is due to be FDA reviewed in September of this year.  It should easily get FDA approval and hopefully those guys won't drag their feet launching the new drug like Shire is doing with Motegrity.

 

And I read on this website: https://bottomlinein...-vibrating-pill that Vibrant is hoping to have their Vibrant capsule available in three years and are planning several phase 3 clinical trials this year, which I'm hoping to get in on.

 

I have no idea about Elobixibat or Velusetrag.  I talked to someone on the forum who was in the Velustrag clinical trial and she said the drug completely cleaned her out within 15 minutes of taking it.

 

The Zelnorm reinstatement is in limbo, after passing out of the FDA GI committee last fall some group filed a protest against it.  Haven't heard anything since.

[annie7]

thanks,  wgbutler, for posting this.  you're always such a good, reliable source for all the latest information.

 

wow--Velustrag really sounds impressive!

[joeyr2]

 

 

Well supposedly Motegrity is going to be released in the first half of this year.  I'm so ticked off at Shire.  The drug has been FDA approved since December 2018 and they haven't launched it yet.  Seems like I've been waiting forever to try this drug out and I'm sick and tired of taking the secretagogues which give me horrible D.  I don't understand why its taking so long considering that they have been selling this drug in Canada and Europe for years.  Its not like this a brand new drug.

 

Tenapanor is due to be FDA reviewed in September of this year.  It should easily get FDA approval and hopefully those guys won't drag their feet launching the new drug like Shire is doing with Motegrity.

 

And I read on this website: https://bottomlinein...-vibrating-pill that Vibrant is hoping to have their Vibrant capsule available in three years and are planning several phase 3 clinical trials this year, which I'm hoping to get in on.

 

I have no idea about Elobixibat or Velusetrag.  I talked to someone on the forum who was in the Velustrag clinical trial and she said the drug completely cleaned her out within 15 minutes of taking it.

 

The Zelnorm reinstatement is in limbo, after passing out of the FDA GI committee last fall some group filed a protest against it.  Haven't heard anything since.

 

In the double-blind trials, one patient reported a suicide attempt 7 days after the end of treatment with MOTEGRITY 2 mg once daily; none were reported in patients on placebo. In the open-label trials, two patients reported a suicide attempt and another patient reported suicidal ideation. Completed suicide was reported in two patients, previously treated with MOTEGRITY 2 mg or 4 mg; both discontinued MOTEGRITY for at least one month prior to the event. 

 

https://www.accessda...0166s000lbl.pdf

[annie7]

 

In the double-blind trials, one patient reported a suicide attempt 7 days after the end of treatment with MOTEGRITY 2 mg once daily; none were reported in patients on placebo. In the open-label trials, two patients reported a suicide attempt and another patient reported suicidal ideation. Completed suicide was reported in two patients, previously treated with MOTEGRITY 2 mg or 4 mg; both discontinued MOTEGRITY for at least one month prior to the event. 

 

https://www.accessda...0166s000lbl.pdf

 

thanks for posting this and letting us know that it's something to be aware of. 

 

i looked up the prescribing info for Resolor--the brand name for prucalopride in europe.  it's been available for years.  i thought it was kind of  interesting that there aren't any warnings about suicide ideation etc in the prescribing information for Resolor .

 

 

https://www.ema.euro...ormation_en.pdf

 

but then i did some more reading and found this  article about suicide ideation with resolor.  i imagine there are similar articles. too:

 

 

https://www.ncbi.nlm...pubmed/23889005

 

hopefully they're right about the "rarely" part. 

 

 there's other meds, such as antidepressants, that list  suicide ideation as a possible side effect too...

[joeyr2]

 

thanks for posting this and letting us know that it's something to be aware of. 

 

i looked up the prescribing info for Resolor--the brand name for prucalopride in europe.  it's been available for years.  i thought it was kind of  interesting that there aren't any warnings about suicide ideation etc in the prescribing information for Resolor .

 

 

https://www.ema.euro...ormation_en.pdf

 

but then i did some more reading and found this  article about suicide ideation with resolor.  i imagine there are similar articles. too:

 

 

https://www.ncbi.nlm...pubmed/23889005

 

hopefully they're right about the "rarely" part. 

 

 there's other meds, such as antidepressants, that list  suicide ideation as a possible side effect too...

I figure if all they are willing to make is garbage meds that dont work for us they should at least not make us suicidal.  We have enough to deal with. 

[wgbutler]

I figure if all they are willing to make is garbage meds that dont work for us they should at least not make us suicidal.  We have enough to deal with. 

 

I have a hard time imagining how medications can make someone commit suicide.  It's not like a pill can control your mind and actions and cause you do things you'd ordinarily not do.  I've been taking anti-depressants for IBS pain management (it makes a noticeable difference in the abdominal and rectal pain) and I've never had any urges to commit suicide.

 

OTOH, I have been suicidal when my IBS symptoms have been really bad.  I don't think I'd ever go through with it, my religious beliefs prohibit that and I have a family that depends on me.  But it makes me wonder if the people who had suicidal thoughts were having them because of their GI symptoms and not because of the drug, because these symptoms can really drag you down emotionally when they are relentless and it looks like there is no relief in sight.

[annie7]

 

 

 

OTOH, I have been suicidal when my IBS symptoms have been really bad.  I don't think I'd ever go through with it, my religious beliefs prohibit that and I have a family that depends on me.  But it makes me wonder if the people who had suicidal thoughts were having them because of their GI symptoms and not because of the drug, because these symptoms can really drag you down emotionally when they are relentless and it looks like there is no relief in sight.

agreed. well said.

[wgbutler]

Just a heads up. Shire has a new customer website for Motegrity:

https://www.motegrity.com

So maybe this means its close to being launched. I have an appointment with my GI in 3 weeks. Im crossing my fingers and hoping it launches before then.