# finally--news about resolor/prucalopride in the usa



## annie7 (Aug 16, 2002)

just read this:Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announced today that it has acquired the rights to develop and market Resolor® (prucalopride) in the United States (US) in an agreement with Janssen Pharmaceutica N.V. Terms of the agreement have not been disclosed http://www.news-medical.net/news/20120110/Shire-acquires-rights-to-develop-and-market-Resolor-in-the-US.aspxhopefully this will get the usa ball rolling--finally!!


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## RYANBOZ7 (Nov 4, 2009)

annie7 said:


> just read this:Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announced today that it has acquired the rights to develop and market Resolor® (prucalopride) in the United States (US) in an agreement with Janssen Pharmaceutica N.V. Terms of the agreement have not been disclosed http://www.news-medical.net/news/20120110/Shire-acquires-rights-to-develop-and-market-Resolor-in-the-US.aspxhopefully this will get the usa ball rolling--finally!!


That's some monkey ###### it's just for women.That is bad news for us men....


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## annie7 (Aug 16, 2002)

oh yes, i hear ya..i don't know why some of the clinical trials for drugs are just run for one sex and not the other. i seem to remember reading an explanation for that on the board here quite a while ago---maybe it was kathleen who provided the explanation for that??? can't remember.but the good news is that the manufacturer has been running clinical trials with resolor on men. and of course i'm sure these drug companies want to make sure their meds are available to as many people as possible--more $$$ for them that way--lol. "Turnhout (Belgium) - 24 September 2010 (2:00 PM CET) - Movetis NV (MOVE), the European gastrointestinal (GI) speciality pharmaceutical company, announces today that it has started a phase III clinical trial with prucalopride in male patients with chronic constipation. Positive results from this clinical trial programme should allow Movetis to support a regulatory application for expansion of the current label of Resolor® (prucalopride)(1)." http://www.drugs.com/clinical_trials/movetis-starts-phase-iii-clinical-trial-prucalopride-male-patients-chronic-constipation-10185.htmlalso this: http://clinicaltrials.gov/ct2/show/NCT01147926?term=prucalopride&rank=14it's so frustrating how long all this takes when we all are desperately waiting for something to help.


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## alxp (Dec 29, 2011)

Annie,I was so excited to read about Resolor . . . until I ran across a forum such as this. The individuals who had begun using Resolor were not seeing results/relief for their chronic constipation. Have you read about A3309? It's another medication for chronic constipation still in the research stages. Sounds promising. I asked my Gastroenterologist recently about A3309. He had not heard of it. His comment was that when Amitiza was initially introduced, it also appeared to be quite successful in relieving chronic constipation. Many of us have tried it and found little relief.I hope Resolor is approved soon. Alex


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## annie7 (Aug 16, 2002)

Hi Alexyes, thanks, i've read about A3309 and i agree--it does sound promising. and thankfully there are other drugs in the pipeline as well. sounds like linaclotide could be approved this year. although that med sounds a lot like amitiza to me and yes, i'm one of the ones for whom amitiza did not work.also in the pipeline is TD-5108 (velusetrag)-- a potent, selective high intrinsic activity serotonin 5-HT4 receptor agonist. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2905526and plecanatide, mentioned in an earlier thread--which also sounds a lot like amitiza. http://www.ibsgroup.org/forums/topic/148058-plecanatide/page__pid__853593#entry853593it's encouraging, knowing that new meds are in development. fingers crossed!


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## jkgreene1976 (Mar 2, 2012)

annie7 said:


> Hi Alexyes, thanks, i've read about A3309 and i agree--it does sound promising. and thankfully there are other drugs in the pipeline as well. sounds like linaclotide could be approved this year. although that med sounds a lot like amitiza to me and yes, i'm one of the ones for whom amitiza did not work.also in the pipeline is TD-5108 (velusetrag)-- a potent, selective high intrinsic activity serotonin 5-HT4 receptor agonist. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2905526and plecanatide, mentioned in an earlier thread--which also sounds a lot like amitiza. http://www.ibsgroup.org/forums/topic/148058-plecanatide/page__pid__853593#entry853593it's encouraging, knowing that new meds are in development. fingers crossed!


I'm a male in the US, my digestive Doc. gave me a prescript for Resolor and directed me to canadadrugs.com , got it and am on third day (2mg a day) odd feeling and mild headache but is better yesterday and today, not much for beneficial effects yet but some obvious gut noises..


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## annie7 (Aug 16, 2002)

jkgreene--thanks so much for keeping us posted! really appreciate it. i'd love to try resolor and would be so happy to sign a waiver--anything!!--in order to get a script for it from my gastro so i could get it from canada drugs but he is a bit conservative (understandably) about stuff like this and wants me to wait until it's fda approved--which could be a long wait...hope resolor starts to work for you real soon. good luck!


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## lowimpact (Jul 3, 2010)

annie7 said:


> jkgreene--thanks so much for keeping us posted! really appreciate it. i'd love to try resolor and would be so happy to sign a waiver--anything!!--in order to get a script for it from my gastro so i could get it from canada drugs but he is a bit conservative (understandably) about stuff like this and wants me to wait until it's fda approved--which could be a long wait...hope resolor starts to work for you real soon. good luck!


I'm American but working in Canada for a bit, I was trying to get some Resolor while i'm there. But i have to say the posts i've read on here were not impressive that it helped that many people. I may get some but I don't have that high of hopes after reading those and will wait until i'm home to try it as most seemed to have problems for a while when they started it.


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## Matilda001 (Oct 18, 2011)

I was just prescribed this today. In fact I started a thread about it before I found this thread. My gastro doc has explained that it isnt fully licensed yet, but that it can be very effective when other meds have been exhausted and providing no relief. I have tried liquid laxatives but they tend to run straight through the colon, bypassing the blockage and just coming straight out the other end as clear as it went in. I am hoping this new med gives me some relief....


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## em_t (Jun 8, 2010)

RYANBOZ7 said:


> That's some monkey ###### it's just for women.That is bad news for us men....


I can understand why you're frustrated that it's only been tested on women so far. I believe the reason is because Chronic Constipation / severe IBS-C tends to affect proportionally more women than men. That's not to say that there aren't men who suffer in this way, but it's more common in women. Therefore most of the clinical trials so far have only been carried out in women. Just as an aside, most clinical trials are carried out in men not women anyway as women's hormones and menstrual cycles can affect how medicines react within the body - therefore it's much more expensive for pharmaceutical companies to recruit women candidates than male candidates because they have to make sure that they have to have an equal number of women at different stages in their menstrual cycle and at different stages in their life (e.g.: post menopausal). From the papers I've read about Prucalopride I seem to remember the researchers saying that they don't think there would be any reason why it wouldn't work in men, just simply that it hadn't been tested on male volunteers yet.


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## Kathleen M. (Nov 16, 1999)

So before the early 1990's every drug was only tested in men. There was no testing at all in any women unless it was for a female reproductive part issue.In the early 1990's the laws were changed and up until phase II every single drug must be tested in both genders unless it is for a body part that only exists in one (so prostate drugs do not have to be tested in women).At the phase II level they are required to do a gender analysis. If there is a gender bias they can only move forward to phase III with the gender where the drug works. A lot of the "why won't they test it in men" drugs were tested early on, but didn't do better than placebo so they can't include them in the phase III testing and if they did it would likely mean they would never get the stats they need to approve it all if you weren't separating out the genders.I know it sucks, but I would hate to go back to the only drugs for men can go through the approval process.Every drug has to have the early tests done in both genders, I don't think they can just pick one gender for giggles, there has to be some early data that indicates single gender testing. Usually I've seen more issues with them forcing inclusion of both genders in small studies where a single gender would help eliminate variables, but if there is a body part as an endpoint that both have, you have to do both even if the main endpoint is a gender specific part.ETA: Did find something that in the must do both gender there were differences especially at certain doses, although they are going back and trying to figure out if there is some reason that may indicate they can show efficacy in men. They can't just refuse to test in men like they used to refuse to ever test any drug in women.


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## em_t (Jun 8, 2010)

Ah Kathleen explained it much better than me.She is the fountain of all knowledge!


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## BQ (May 22, 2000)

Yes I believe she is.. LOL







Go Kathleen Go!I too am overjoyed there is FINALLY light at the end of this Resolor tunnel!!! YAY!


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## annie7 (Aug 16, 2002)

thanks, Kathleen!


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## Matilda001 (Oct 18, 2011)

I just handed my script in for the prucolapride, and the pharmacy didnt have it in and infact the pharmacist said he hasnt seen a prescription for that in years? The way my gastro described the med to me was that it was a new drug. According to my pharmacist its been around for years and not used much now due to its ineffectiveness? I will be starting it on wednesday, Im off work for a week so will be able to get to the loo urgently, if the prucolapride does what its meant to. I am taking it with an open mind, if perhaps somewhat hopeful that it might kick start my lazy bowel..


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## annie7 (Aug 16, 2002)

prucalopride is a newer drug--approved for use in europe in 2009. not sure exactly when in the uk--sometime shortly after the european approval, i believe. your pharmacist sounds a bit confused perhaps...good luck! fingers crossed it works for you!! please keep us posted if you get a chance--thanks!


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## Matilda001 (Oct 18, 2011)

annie7 said:


> prucalopride is a newer drug--approved for use in europe in 2009. not sure exactly when in the uk--sometime shortly after the european approval, i believe. your pharmacist sounds a bit confused perhaps...good luck! fingers crossed it works for you!! please keep us posted if you get a chance--thanks!


thanks, I will update once I have started it. the gastro told me that possible side effects are headaches, nausea and abdominal pain! Just a typical day for me then so Im sure I wont notice any difference


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## annie7 (Aug 16, 2002)

oh i hear you--just a day in the life--lol...


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## RYANBOZ7 (Nov 4, 2009)

em_t said:


> I can understand why you're frustrated that it's only been tested on women so far. I believe the reason is because Chronic Constipation / severe IBS-C tends to affect proportionally more women than men. That's not to say that there aren't men who suffer in this way, but it's more common in women. Therefore most of the clinical trials so far have only been carried out in women. Just as an aside, most clinical trials are carried out in men not women anyway as women's hormones and menstrual cycles can affect how medicines react within the body - therefore it's much more expensive for pharmaceutical companies to recruit women candidates than male candidates because they have to make sure that they have to have an equal number of women at different stages in their menstrual cycle and at different stages in their life (e.g.: post menopausal). From the papers I've read about Prucalopride I seem to remember the researchers saying that they don't think there would be any reason why it wouldn't work in men, just simply that it hadn't been tested on male volunteers yet.


Ok thanks!


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