Irritable Bowel Syndrome and Digestive Health Support Forum banner
1 - 11 of 11 Posts

·
Registered
Joined
·
9,141 Posts
Discussion Starter · #1 ·
http://www.docguide.com/news/content.nsf/n...document&wf=yesLubiprostone a New Option for Treatment of Constipation: Presented at WCOGBy Danny KucharskyMONTREAL, CANADA -- September 16, 2005 -- Lubiprostone 24 mcg twice daily is significantly more effective than placebo in providing relief from chronic idiopathic constipation, according to a phase 3 study presented here September 14th at the World Congress of Gastroenterology (WCOG).Researchers conducted the multicentre, randomised, placebo-controlled study at 20 sites in the United States and involving 242 subjects with constipation. Subjects were randomly assigned to receive either 24 mcg twice daily of lubiprostone or matching placebo twice daily for 4 weeks.Lubiprostone is a novel chloride channel activator that enhances fluid secretion into the intestinal lumen, according to presenter Christopher Holland, PharmD, director of biostatistics and clinical data, Sucampo Pharmaceuticals Inc., Research and Development, Bethesda, Maryland, United States.After the 4 weeks of treatment, patients underwent a 2-week follow-up period. Throughout the treatment and follow-up periods, patients documented bowel activity, bowel movement assessments, and rescue medication use.An intent-to-treat analysis found a significant increase in spontaneous bowel movements in the lubiprostone group compared with the placebo group. The increased weekly spontaneous bowel movements with lubiprostone continued throughout the study, with frequencies ranging from 5.1 to 5.7 in the lubiprostone group compared with 2.8 to 3.5 in the placebo group (P < .0020 at all weeks).Bowel movements occurred within a shorter time after the initial lubiprostone dose compared with placebo. Within 24 hours of the first dose, 57% of lubiprostone patients had a spontaneous bowel movement compared with 37% in the placebo group (P = .0024).Patient global assessment of treatment effectiveness was significantly better in the lubiprostone group than in the placebo for the 4-week treatment period (P < .001 at all weeks).There was 1 serious adverse event in the placebo treatment group. Nine patients in the lubiprostone group withdrew due to adverse events. The majority of adverse events were mild with nausea experienced by 31.7% of the 120 patients (P < .001) and headache by 11.7% in the lubiprostone group (P = .015).The primary endpoint for the study was spontaneous bowel movements at week 1 and "we saw a statistically significant difference there," Dr. Holland said.The study was previously presented at Digestive Disease Week 2003. The drug is now in prelaunch activities.Support for the study was provided by Sucampo Pharmaceuticals. The company submitted a new drug application to the United States Food and Drug Administration (FDA) on March 31, 2005 to market the compound for the treatment of chronic idiopathic constipation (CIC) and associated symptoms in adults. Is it available in USA now?
 

·
Registered
Joined
·
82 Posts
I'm looking forward to trying this drug. My memory of the FDA guidelines is they have 6 months to approve a drug that has no comparable drug on the market, (which Lubriprostone doesn't). If there's a comparable drug, they have 12 months to approve. If there's an ammendment to the NDA, I think they tack on 2 months to the approval process. (Something like that). It should be on the market in the near future. Hope so!
 

·
Registered
Joined
·
9,141 Posts
Discussion Starter · #4 ·
Why not call them?
 

·
Registered
Joined
·
36 Posts
That's awesome news! Maybe we will finally find a treatment and get on with our lives.Seems funny though that they came up with this drug only now, when all it does is helps your intestines absorb water better.I mean it's not like it's a drug that's fixing the colon forever with one treatment. Seems like this drug should have been made a long time ago.Well anyways, I hope they approve it! I really really hate coffee.
 

·
Registered
Joined
·
9,141 Posts
Discussion Starter · #6 ·
And coffee dosen't works everytime.
 

·
Registered
Joined
·
9,141 Posts
Discussion Starter · #9 ·

·
Registered
Joined
·
9,141 Posts
Discussion Starter · #10 ·
http://www.sucampo.com/article_61.shtmlNew Study Found Lubiprostone Increased Spontaneous Bowel Movement Frequency and Improved Symptoms in Patients With Chronic Constipation When Compared to Placebo Release Date: Oct 31, 2005 Email this release Printer friendly page Investigational treatment may offer relief to millions of Americans with chronic constipation when the product is approved.HONOLULU, HAWAII â€" October 31, 2005 â€" Sucampo Pharmaceuticals, Inc. today announced study results with lubiprostone, an investigational compound for the treatment of chronic idiopathic constipation. In this study, 61 percent of patients taking lubiprostone experienced a prompt effect, reporting at least one spontaneous bowel movement (SBM) within the first 24 hours of treatment versus 31 percent of patients receiving placebo. Patients taking lubiprostone also experienced a sustained effect, reporting an increased number of SBMs per week. These data were presented today at the 70th annual meeting of the American College of Gastroenterology (ACG). Additional studies found that lubiprostone significantly reduced the severity of constipation.Lubiprostone is a novel chloride-channel activator that works by increasing fluid secretion in the intestines to treat constipation. A new drug application (NDA) was submitted to the U.S. Food and Drug Administration (FDA) in March 2005 to market lubiprostone for the treatment of chronic idiopathic constipation and associated symptoms in adults. In addition, a Phase III clinical development program for lubiprostone in patients with constipation-predominant irritable bowel syndrome (C-IBS) was recently initiated. “Chronic constipation, a very common problem in the United States, can negatively impact a person’s lifestyle due to straining, hard stools and bloating, which in some cases can be extreme,” said John Johanson, M.D., clinical associate professor, University of Illinois College of Medicine, and study investigator. “These study results indicate that chronic constipation sufferers may have new hope with lubiprostone.”Study DesignsA Phase III multicenter, parallel-group, double blind, randomized, placebo-controlled study examined 237 subjects who had a history of fewer than three SBMs per week and at least a six-month history of other symptoms of chronic constipation. The subjects were randomized to receive either 24 micrograms of lubiprostone or a matching placebo tablet twice daily for a 28-day period. It was found that patients in the lubiprostone group increased to 5.89 SBMs within the first week, versus 3.99 in the placebo group. Additionally, patients in the lubiprostone group experienced a decreased degree of straining and improvement in stool consistency and constipation severity. These effects were sustained through the duration of the study. Also, more than 61 percent of participants experienced at least one SBM in the first 24 hours (versus 31.4 percent in the placebo-treated subjects). The results of this study were confirmed in Phase III patient assessments of the effects of lubiprostone, where subjects were asked to evaluate bowel movements and various symptoms of chronic constipation (e.g., severity, bloating and discomfort, consistency and straining).“Current treatment options for chronic constipation are often poorly tolerated or ineffective,” said Ryuji Ueno, M.D., PhD. PhD., chief scientific officer at Sucampo Pharmaceuticals, Inc. “These data are important because they show that patients who took lubiprostone were found to have improvements in symptoms of constipation, such as straining during bowel movements and lumpy or hard stool.”Long-term open-label data was also presented at ACG that evaluated lubiprostone in 306 subjects over a six-month period. Patients reported continued relief from many symptoms associated with constipation, including constipation severity, bloating and abdominal discomfort. In these studies, the most common side effects were nausea, diarrhea and headache; these were generally classified as mild to moderate in severity.Lubiprostone is an investigational compound currently being evaluated by the FDA for the treatment of chronic idiopathic constipation and will be jointly marketed by Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceuticals North America, Inc. when the product is approved. About Chronic ConstipationConstipation, defined as infrequent and difficult passage of stool, is one of the most common digestive complaints. It is reported that constipation affects over 30 million people in the United States and is the cause of 2.5 million visits to physicians and 92,000 hospitalizations annually. The condition becomes chronic when a person has two or more defining symptoms (including straining during bowel movements, lumpy or hard stool, sensation of incomplete evacuation or fewer than three bowel movements a week), for at least 12 nonconsecutive weeks over a period of 12 months. While chronic constipation is a common problem, currently available treatments have been far from satisfactory as they often fail to control symptoms adequately, produce problematic side effects, or lose effectiveness over time.Sucampo Pharmaceuticals, Inc. is a pharmaceutical company that concentrates on developing compounds from its proprietary functional fatty acid technology platform, which consists of exclusive rights in the Americas to a portfolio of more than 650 patents. The company, founded in 1996 by Dr. Ryuji Ueno and Dr. Sachiko Kuno in Bethesda, MD, focuses principally on developing novel therapies for gastrointestinal, liver and circulatory indications, and is strategically selecting and developing candidates for other indications. Sucampo’s functional fatty acid platform is based on the discoveries of Company Founder, Dr. Ryuji Ueno. To learn more about Sucampo, visit http://www.sucampo.com.
 

·
Registered
Joined
·
262 Posts
I know the conventional wisdom is that Quetstran is for D-IBS, but I have found it necessary for releiving my constipation. Don't try this at home, because Questran doesn't work without my procedure and my procedure probably won't work on you. But, Lubiprostone will function equivalently to Questran! What I am going to try to do in the following post is to equate the conditions being brought about by Questran with those of Lubiprostone. Bile acid resins (Questran) basically filter out bile from the entero-hepatic circulation (EHC--re-uptake in the liquid state of feces). Most of the water gets absorbed at the terminal ileum, and bile enters the EHC there, even with Questran. The neurotransmitter Neurotensin mediates the re-uptake at the intestine, and its effect is amplified/potentiated by PGE2 (prostaglandin E2). Questran actually increases Neurotensin at the ileum, (I can make a list of references if anyone wants it). PGE2 leads to an increase in VIP (vasoactive intestinal polypeptide) at the ileum, associated with neuronal Nitric oxide synthase, and both of these neurotransmitters transmit via ATP. ATP causes a conformational shape change in sub-epithelial fibroblasts, from stellate to flat, which functions as an actin cyto-skeletal sieve, to decrease ileal permeability to water (equivalent to Lubiprostone causing water secretion).Switching to Joke mode: When you're lost and ask for directions out West they say "I hope I didn't give you a bum steer."
 
1 - 11 of 11 Posts
This is an older thread, you may not receive a response, and could be reviving an old thread. Please consider creating a new thread.
Top