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FDA Accepts Sucampo’s SNDA For Lubiprostone (8 Mcg) For The Treatment Of Irritable Bowel Syndrome With Constipation (IBS-C)

Sucampo Pharmaceuticals, Inc., (Nasdaq: SCMP) announced that the supplemental New Drug Application (sNDA) for lubiprostone (8 mcg, oral gel capsules, twice daily) for the treatment of irritable bowel syndrome with constipation (IBS-C) has been accepted for review by the U.S. Food and Drug Administration (FDA). Sucampo Pharmaceuticals currently anticipates a decision from the FDA in the second quarter of 2008.

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Posted in Irritable-Bowel Syndrome on Sep 18th, 2007, 2:00 am     

IBS Treatment: Is Bacteria the Missing Link?

Irritable Bowel Syndrome (IBS) is the most common chronic digestive condition with more than 60
million people coping with  abdominal pain, bloating, and altered
bowel habits, including constipation and diarrhea.

Dr. Mark Pimentel, Director of the Gastrointestinal Motility
Program at Cedars-Sinai
Medical Center,
has written a book entitled “A New IBS Solution:  Bacteria-The Missing Link in treating
Irritable Bowel Syndrome.”
  Here he talks
about simple solutions to help people alleviate their Irritable Bowel (IBS) symptoms.

 On digestive enzymes:

Q) 
In your book, you discuss some of the advantages of taking digestive
enzymes
.  What are some of those benefits,
and how do they relate to your assertion that IBS patients are suffering from
an overgrowth of bacteria in the small intestines?

A) The basis for using digestive
enzymes
in treating IBS is that I believe taking the enzymes will increase the
speed of digestion. The faster the food is digested, the quicker it is
absorbed. This leaves fewer available calories (or nutrients) for the bacteria
of the gut. With this reduced number of calories, the bacteria will likely
decrease in number. Typically, patients who take pancreatic enzymes report a
30% - 40% improvement in their symptoms.

On peppermint capsules:

Q) What are some of the reasons you
recommend peppermint capsules for your patients suffering from the effects of
IBS?  Is there a particular kind of
capsule that works more effectively?

A) Peppermint has been shown to be
a calcium channel blocker of the muscle because of its ability to block calcium
fluctuations in the muscle cells, thereby causing muscles to relax.  When taking peppermint, the muscles of the
stomach, small intestine, and colon are less likely to contract against gases,
reducing the sensations of high pressure (or cramping) in the abdomen.  To achieve the above benefits, the peppermint
needs to be enteric-coated
to protect it from being broken down and digested
prior to reaching the important areas of the gastrointestinal tract.

On probiotics:

Q) We hear a lot about probiotics?
What exactly are they? There has been some research suggesting they may be
beneficial in improving motility and digestion.

A) Probiotics such as
lactobacillus and bifidobacteria provide relief to the severity of IBS symptoms
by stimulating the cleansing wave mechanism of the intestines.  In a double-blind study involving fifty
patients with IBS, test subjects received either the probiotics or a placebo
powder for a period of 28 days.  At the
end of the study, 49% of the probiotic group showed improvements in the level
of their abdominal pain, compared with 29% of the placebo group.  While probiotics have not been found to
eliminate IBS, the reduction of IBS symptoms is certainly a good outcome.

For further information:

Antibiotics as IBS treatment

Testing for small intestine bacterial overgrowth

 Dr. William Chey on IBS

 

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Posted in Irritable-Bowel Syndrome on Sep 6th, 2007, 1:21 pm     

Lexicon Presents Class Of Compounds Modulating TPH1, The Target For Its LX1031 Investigational Drug For Irritable Bowel Syndrome

Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) presented data today describing the structure-activity relationship (SAR) of a class of internally-developed compounds that includes LX1031 and other compounds under evaluation by the company as potential treatments for irritable bowel syndrome (IBS) and other gastrointestinal disorders. LX1031 is currently under evaluation in a Phase 1b clinical trial in healthy volunteers.

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Posted in Irritable-Bowel Syndrome on Aug 22nd, 2007, 2:00 am     

Important Facts About Irritable Bowel Syndrome

Irritable Bowel Syndrome (IBS) is a disorder of bowel function. Patients who suffer from irritable bowel syndrome have abdominal pain or discomfort accompanied by changes in bowel habits such as constipation or diarrhea (or both). Additional symptoms of IBS include abdominal bloating, loss of appetite, and general malaise.IBS is an extremely common disorder. Studies have estimated the prevalence in the United States to be somewhere between 15% and 20% of the entire population.

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Posted in Irritable-Bowel Syndrome on Aug 9th, 2007, 2:00 am     

Management Of Inflammatory Bowel Disease Improved By Biologics

The use of biologic agents for the treatment of inflammatory bowel disease (IBD) may benefit patients, but doctors need to consider the potential associated side effects in determining treatment course, according to a consensus paper published in this month’s issue of Gastroenterology, the official journal of the American Gastroenterological Association (AGA) Institute.

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Posted in Irritable-Bowel Syndrome on Jul 29th, 2007, 11:00 am     

Zelnorm(R) To Be Made Available To US Patients Under Restricted Access Program

In cooperation with the US Food and Drug Administration (FDA), Novartis has established a restricted access program for Zelnorm(R) (tegaserod maleate) so that patients in need of this medicine can be considered for treatment.

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Posted in Irritable-Bowel Syndrome on Jul 28th, 2007, 2:00 am     

Supplemental New Drug Application For Lubiprostone To Treat IBS With Constipation Submitted By Sucampo Pharmaceuticals

Sucampo Pharmaceuticals, Inc., (Sucampo Pharmaceuticals) has announced that it has submitted a supplemental New Drug Application to the U.S. Food and Drug Administration to seek market approval of a lower strength of lubiprostone (8 mcg) to treat irritable bowel syndrome with constipation (IBS-C).

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Posted in Irritable-Bowel Syndrome on Jul 17th, 2007, 5:00 am     

Sucampo Pharmaceuticals Submits Supplemental New Drug Application For Lubiprostone To Treat Irritable Bowel Syndrome With Constipation

Sucampo Pharmaceuticals, Inc., (Sucampo Pharmaceuticals) today announced that it has submitted a supplemental New Drug Application to the U.S. Food and Drug Administration to seek market approval of a lower strength of lubiprostone (8 mcg) to treat irritable bowel syndrome with constipation (IBS-C).

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Posted in Irritable-Bowel Syndrome on Jul 13th, 2007, 2:00 am     

Heart Drugs May Help People With Bowel Disorders

Statin drugs which are widely prescribed to prevent heart disease may emerge as a future treatment for Crohn’s disease, an inflammatory bowel condition, a scientist said last Tuesday. Surgical research fellow Dr. John Burke was addressing the Association of Coloproctology meeting in Glagow about research which is reinforcing the idea that statins are becoming ‘the aspirin of the 21st Century’.

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Posted in Irritable-Bowel Syndrome on Jul 7th, 2007, 3:00 am     

A Psychological Approach To The Management Of Irritable Bowel Syndrome

Antidepressants and psychological treatments such as hypnotherapy have the potential to help patients with severe irritable bowel syndrome (IBS), say researchers in this week’s BMJ.IBS is a very common disorder, but conventional ‘physical’ treatments often do not work very well and patients can feel that their symptoms are being ignored, downplayed or misunderstood.

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Posted in Irritable-Bowel Syndrome on May 30th, 2007, 9:00 am     

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