# Lubiprostone Approved by the FDA



## 18223 (Jan 16, 2006)

The FDA today approved Amitiza (lubiprostone), the first drug of its chemical type, for the treatment of chronic constipation in the adult population where there is no known cause for the condition. The product will be available as capsules for use by adults to treat idiopathic constipation cases not caused by other diseases or by use of medications. Chronic idiopathic constipation is generally defined as infrequent and difficult passage of stool and is one of the most common disorders suffered by Americans. This condition affects women more often than men and also affects older patients after the age of 65 more frequently. Symptoms of chronic idiopathic constipation are abdominal pain and discomfort, bloating, straining, and hard stools. Amitiza works by increasing the intestinal fluid secretion, which helps ease the passage of stool and helps alleviate symptoms associated with chronic idiopathic constipation. FDA based its decision to approve Amitiza on the results from two clinical trials, which were conducted in patients with, on average, less than 3 spontaneous bowel movements per week with symptoms of constipation for at least 6 months prior to entry into the studies. The studies demonstrated that subjects treated with Amitiza had a higher frequency of bowel movements in the first week than the placebo subjects. In both studies, results similar to those in Week 1 were also observed in Weeks 2, 3, and 4 of therapy. In addition, three long-term studies showed that Amitiza decreased constipation severity, abdominal bloating and discomfort over 6-12 months of use.The most common adverse events reported in the trials included headache, nausea, diarrhea, abdominal pain, and distension. Whether these events are related to the drug is not known at present. Amitiza should be taken twice a day with food. Physicians and patients should periodically assess the need for continued treatment. Amitiza is marketed by Sucampo Pharmaceuticals, Inc., Bethesda, MD., and by Takeda Pharmaceuticals America, Lincolnshire, IL. http://www.fda.gov/bbs/topics/news/2006/NEW01305.html


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## 17176 (Mar 31, 2005)

hello and welcome


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## SpAsMaN* (May 11, 2002)

http://www.sucampo.com/cat_index_5.shtmlJan 31, 2006SUCAMPO OBTAINS FDA APPROVAL FOR AMITIZAâ„¢ CAPSULES AS TREATMENT FOR CHRONIC IDIOPATHIC CONSTIPATION IN ADULTSBethesda, MD (January 31, 2006) -- Sucampo Pharmaceuticals, Inc., today announced that the U.S. Food and Drug Administration has approved the new drug application for AMITIZAâ„¢ (lubiprostone) capsules, an oral treatment of chronic idiopathic constipation in adults. AMITIZAâ„¢ is the first selective chloride channel activator approved for therapeutic use and has been shown to offer effective relief of chronic idiopathic constipation in adults. This condition affects women more often than men and also affects older patients after the age of 65 more frequently.


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## SpAsMaN* (May 11, 2002)

Yououou!A new candy!


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## 18223 (Jan 16, 2006)

Anyone have any idea how long it will take for this to be available for the public?


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## SpAsMaN* (May 11, 2002)

Call your drug stores and tell me if it is.


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## Kathleen M. (Nov 16, 1999)

Generally between approval and on the shelf time is a few months. They have to get production geared up, and they usually only do that after approval is in (who wants to be stuck with a million pills you can't sell).K.


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## Guest (Feb 1, 2006)

yeah, and will it be approved in Canada?







SweetBon


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## SpAsMaN* (May 11, 2002)

As soon as it is released,SpasMaN will get it on-line.


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## Tiss (Aug 22, 2000)

How does it differ from Zelnorm?


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## Cartoon Creature (Jul 12, 2002)

Thats a really good question. How does it differ from Zelnorm?Al so I wonder if it will ever make its way to Australia. Maybe those who dont get it in thier country could order it online.Poo Pea


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## flux (Dec 13, 1998)

> quote:How does it differ from Zelnorm?


Zelnorm is a partial 5HT-4 agonist. That works at a higher level to induce secretion (of water) into the intestinal lumen than this new drug, which acts directly on chloride channels to open them. Putting chloride into the lumen brings water into the gut lumen via osmosis. Zelnorm also has direct effects on motility through its 5HT-4 agonist effect. Specifically, in increases peristalsis (frequency) in the small bowel as well as changes to motility both increasing phasic contractions in the colon to facilitate transit.


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## atrain (Jun 22, 2001)

So Flux, in your opinion, if Zelnorm also attempts to promote motility, will this new drug me less effective than Zelnorm for the people with severe chronic C?


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## Kathleen M. (Nov 16, 1999)

There are other parts to the equation than just what it does.What your body actually needs, how you as an individual process the drug, etc.It is really hard to guess if drug X doesn't work how well drug Y will.The clinical trial data I saw summarized looked like this new drug works for a fair number of people. But I've seen no comparison studies (which normally are not done prior to approval) or information about who it worked for with which drug histories they have.K.


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## flux (Dec 13, 1998)

> quote:if Zelnorm also attempts to promote motility, will this new drug me less effective than Zelnorm for the people with severe chronic C?


I would not assume that. Definitely worth looking into


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## SpAsMaN* (May 11, 2002)




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## SpAsMaN* (May 11, 2002)

Lubi:http://www.amitiza.com/


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## 20708 (Mar 28, 2005)

Just last week, while talking to the nurse in my gastro's office, I mentioned that I'd read that something new was about to be approved by the FDA for C, and she said she'd not heard of that. I guess this is it! She did say if I found any info to let her know, so you bet I'm giving her this info on Tuesday (Monday here is a holiday)I'll let you all know what happens.Since my Zelnorm stopped working last week, this is really of prime interest to me.


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## SpAsMaN* (May 11, 2002)

They say only for spring 2006








:http://www.sucampo.com/article_62.shtml


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## 20708 (Mar 28, 2005)

Spring 06 is now, Spasman! Although, I called my Dr's office yesterday to ask about this drug and here's what I got:We've never heard of it.It might not be available in this market area yet.We've never heard of it.We won't know until the drug salesmen come around telling us about it.We've never heard of it.OK, I got that she'd never heard of it, but does that make it not exist?? I guess they didn't like a patient scooping the drug rep's on a new drug.She said maybe some Dr's in 'the city' (Boston) have heard of it....Not what I was hoping for.


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## SpAsMaN* (May 11, 2002)

I tougth spring was summer.


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## SpAsMaN* (May 11, 2002)

I will try to call Amitza tomorrow,i want to know when.


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## SpAsMaN* (May 11, 2002)

I just called them(Sucampo).*Available in the beginning of May.*2 more months


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## SpAsMaN* (May 11, 2002)

If you look at their pipeline it is FDA approved for chronic C and IBS-C is on clinical trial.But if you ask your doctor in USA,i guess he will get it "off label":http://www.sucampo.com/inthepipeline.html#1


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## 20708 (Mar 28, 2005)

Spas, I can't thank you enough for all the research you do and share with us. So, this wonder drug is going to be available in May? Hopefully by then, my gastro's office will have heard of this!


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## SpAsMaN* (May 11, 2002)




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## 2btrue (Jul 22, 2003)

I wonder how this will effect the pain issue and how this would be compatible with narcotics.Zelnorm doesnt help the constipation effects of nactocis at all but this does seem different. Zelnorm increases pain, bloating and gas for me as I have heard from others too. Hope this will be different.


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## 2btrue (Jul 22, 2003)

Anyone know how this would effect the pain aspect?


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## SpAsMaN* (May 11, 2002)

2b,a gas who moves dosen't cause pain.


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## 2btrue (Jul 22, 2003)

Spasman,Thats sooo NOT true. Gas that doesnt move builds up intense pressure!!!!


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## SpAsMaN* (May 11, 2002)

That's what i said.


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## 2btrue (Jul 22, 2003)

What did you say?


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## SpAsMaN* (May 11, 2002)

> quote:a gas who moves dosen't cause pain.


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## 19739 (Mar 3, 2006)

In your quote you mention: IBS induced by NAPROXEN(NSAIDS)I have been suffering from IBS for probably close to 20 years but it became worse when I moved to the US (originally europe)almost 10 years ago. I have now adjusted my diet, take pancreative with my meals and am on Zelnorm ....but I still have severe symptoms. I also take Naproxen (in combination with tyl-3) for my migraines and although I know that the tyl-3 can cause C- I have never heard of Naproxen being linked to IBS... Can you give me some more information on that?Thanks!SterreDerZee


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## SpAsMaN* (May 11, 2002)

10 years ago,i took Naproxen.I have had acute lower bowel cramps and had to go at the E.R. to receive an enema.My bowel has never heal since.I think it is the small bowel mucosa and i'm looking to get the pill camera to check my small bowel.


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## SpAsMaN* (May 11, 2002)

DETAILS ON THE AMITZA CLINICALS TRIALS:http://www.sucampo.com/downloads/2006.02.01_AMITIZA.pdf


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## 19739 (Mar 3, 2006)

How long did you take Naproxen and how much? When I moved to the states my C-became so severe that I had to go to the ER several times and I knew I had IBS but this seemed to be something much worse. So I went through all the tests (again) and received IBS Diagnose. At the same time, the combination of naproxend and tyl3 seems to be the only cure for an acute migraine attack, so I have been using the naproxen even back in Europe.. I have migraines reguarly but not often enough for a beta blocker so I would not know what to take as an alternative to naproxen. However your story does raise some serious concerns... Have you ever come accross anyone else or have done any research on the combination?Thanks!SterreDerZee


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## SpAsMaN* (May 11, 2002)

I only took it for few days and then the acute lower bowel cramps occurs.However,my pelvis was already sensitive.It just overflowed with Naproxen and IBS was born.


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## 2btrue (Jul 22, 2003)

Every drug has a different effect on different people and has a very potent potential for stomach problems, upper and lower- the most common problem.I personally had to have my entire colon removed from the use of too many antibiotics! Thats how severe it can become.So much for the wonders of drugs - now I am in a much much worse situation.


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## 2btrue (Jul 22, 2003)

Spasman,why do you have that picture of a spastic colon on some of your postings? Did you know you can have severe and similar pain/issues/functional problems and have no colon?By the way, gas that doesnt move is more painful than you can imagine. One probably has to experience it to realize it - the pressure, pulling can be intense!


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## SpAsMaN* (May 11, 2002)

2btrue sweetheart.I know trapped gas can cause pain beleive me.I was in hell everyday with till i've tried Colace.Now my head aches are almost gone and i have almost normal BM.I still have IBS however.


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## SpAsMaN* (May 11, 2002)

> quote:I personally had to have my entire colon removed from the use of too many antibiotics! Thats how severe it can become.


The fact that you have your colon removed because of antibiotics is disturbing.


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## 2btrue (Jul 22, 2003)

I think what we are ALL going through is very distubing


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## SpAsMaN* (May 11, 2002)

2b,do you have pain in the pubis area?I mean very low on the pubic bone?


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## 2btrue (Jul 22, 2003)

Spasman,No, only the area associated to my surgery which was a total colectomy with Ileorectal Anastamosis. I have pain in the lower abdomen/intestinal area only. Due to surgery radiologists are unable to clearly read a CT and US. I cannot have any of the latest "Pill in a camera tests" due to scare tissue and adhesion intrapment. oh well, I guess that says a lot ...!!!!?


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## SpAsMaN* (May 11, 2002)

Did you tried to contact this guy?This is a adhesion specialist:http://www.clarkgerhart.com/


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## SpAsMaN* (May 11, 2002)

Regarding the pubic bone pain,i'm almost sure it's the small bowel since this is where people get inguinal hernia and from what i've seen from my barium x-rays.


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## 2btrue (Jul 22, 2003)

Thankfully I have NOT experienced pubic bone pain.That web site is very scary - surgery to remove internal scar tissue is not recommended and usually has a success rate of less than 5% due to new increased scar tissue forming. After major surgery Laproscopic surgery cannot be formed due to thickness and extend of scar tissue. Everyone develops scar tissue after surgery but they dont always develop pain - it all depends on one's anatomy, nervous system, healing, surgery technique and many more factors that are unknow to me.


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## 2btrue (Jul 22, 2003)

We've kind of got off the main topic here - does anyone know if there's been any progress as to the approval of Lubiprostone??


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## SpAsMaN* (May 11, 2002)

Someone should call Sucampo to get the date of the release.I have a friend in Australia in problem after surgery like you.You can send me an e-mail if you want to discuss with her.


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## 2btrue (Jul 22, 2003)

Thanks for the offer but I prefer not to dwell too much about this problem, just makes things worse me.Thanks again.


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## 16522 (Apr 6, 2005)

I've been told that I have colonic inertia, but was a poor candidate for the surgery due to my bad pain. I was told that the surgery helps with constipation and blkoating, but not necessarily the pain. I was told the reason is something to do with the brain-gut syndrome. Although the colon has been removed colonic inertia is a functional disease as opposed to something like Crohn's disease and the memory of the pain still remains in the brain. Sounds crazy but I was told this by two different colo-rectal surgeons. Also, I was told that some people are okay for 1-2years and then develop problems after that and I've heard of people having to get an ileostomy because the constipation came back o bad again and some people developed inertia of the small colon. I would never want to scare anyone from getting this surgery, but surgeons as I found out because I had an ileostomy for awhile because some surgeon told me by diverting the stool out of my large colon I would feel better, have a better quality of life and would be able to eat better. He was wrong. I still had pain and still couldn't eat right. An ileostomy is a b---ch to take care of and it wasn't worth it. So, I had a reversal and now my pain is worse then before the ileostomy. So my point is some surgeons don't tell you everything or tell you things and then the story changes after the surgery. One needts to get several opinions and know all the facts. I already made one mistake and after two surgeries, I don't want to be anywhere near a hospital. I'd rather suffer at home.


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## SpAsMaN* (May 11, 2002)

Surgeons are trying to help,unfortunaly the gut is a sensitive organs.


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