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Digestive Health Matters Vol. 23 No.1

Feature Articles

Treatment News

Here are summaries of some recent news about research and treatments for digestive health.

Data Supports Long-Term Use of Gattex for Treatment of Short Bowel Syndrome

Data from a two-year study by NPS Pharmaceuticals supports the long-term use of Gattex for injection in adult patients with short bowel syndrome (SBS). The findings were published as an abstract and presented at the American College of Gastroenterology (ACG) Annual Scientific Meeting and Postgraduate Course in San Diego, CA in October 2013. Patients in the study using Gattex beyond one year continued to be able to reduce their support on parenteral nutrition.

The open-label extension study included 88 adult patients with SBS. Investigators reported that the long-term use of Gattex in patients with SBS resulted in additional, clinically meaningful reductions in the volume and days per week of parenteral support requirements in this extension study. Thirteen patients in the study achieved complete independence from parenteral support with long-term Gattex therapy. No new unexpected safety concerns were observed with long-term Gattex treatment and the product’s safety profile remains consistent with the product’s label.

Gattex is a product of NPS Pharmaceuticals, a specialty pharmaceutical company developing orphan therapeutics for rare gastrointestinal and endocrine disorders. The drug works by regeneration of cells in the intestinal lining, slowing down transit through the gut and increasing blood flow, allowing for increased nutrient absorption. In studies, the drug was associated with achieving and maintaining clinically meaningful reductions in parenteral nutrition (PN) and intravenous (IV) fluid volume in adult subjects with SBS.

Gattex was approved by the U.S. Food and Drug Administration (FDA) in 2012 for treatment of adult patients with SBS who are dependent on parenteral support. To help ensure that the benefits of Gattex outweigh the risks for causing other serious conditions, the drug is approved with a Risk Evaluation and Mitigation Strategy, which patients need to discuss with their doctors. While the researchers found the safety profile to be acceptable, they advise that physicians closely monitor patients beginning the drug for side effects and possible need to adjust dosage.

SBS is a rare condition related to poor absorption of nutrients. It typically occurs in people who have a significant portion of their small intestine removed due to disease or injury. They cannot absorb enough water, vitamins, and other nutrients from food and may then need to use parenteral nutrition and intravenous fluids.

Rifaximin Studied for Treatment of Non-Constipation IBS

Rifaximin is an antibiotic currently under investigation for the treatment of nonconstipation Irritable Bowel Syndrome (Non-C IBS) and IBS-related bloating. Rifaximin works by reducing or altering bacteria in the gut. In studies it has been found to improve IBS symptoms of bloating, belly pain, and diarrhea after a 10–14 day course of treatment. It is only slightly absorbed in the gut and is generally tolerated well. Rifaximin has not yet been approved by the U.S. Food and Drug Administration (FDA) for the treatment of IBS.

Elobixibat for Treatment of Chronic Constipation Now in Phase 3 Clinical Trials

Phase 3 trials of elobixibat for the indication of chronic idiopathic constipation (CIC) have begun. Ferring Pharmaceuticals reports that two studies are being conducted at close to 200 sites around the world. In Phase 2b clinical trials in the U.S. and Europe, elobixibat (formerly A3309) demonstrated clinically meaningful, statistically significant, and dose-dependent improvements, including increased stool frequency and improved constipation-related symptoms such as straining, stool consistency, and bloating maintained over eight weeks of treatment.

Elobixibat is a first-in-class compound under investigation for treatment of CIC and for IBS with constipation (IBS-C). It works by reducing bile acid absorption in the small intestine. This stimulates bowel movements by increasing fluid secretions and motility in the colon.

Solesta Available in the U.S. to Treat Bowel Incontinence

Solesta, a biocompatible tissue bulking agent, was approved by the U.S. Food and Drug Administration (FDA) for the treatment of bowel incontinence in patients 18 years and older who have failed conservative therapy (e.g., diet, fiber therapy, anti-motility medications). The drug has been approved to treat bowel incontinence in the U.S. since 2011 and in Europe since 2006. Bowel incontinence is the involuntary loss of bowel control. While the exact mechanism of action has not been identified, it is thought that the Solesta injections may narrow the anal canal and allow for better control of those muscles.

Solesta is an injectable gel delivered into the anal canal in an outpatient procedure taking approximately 10 minutes without the need for surgery or anesthesia. It should only be administered by physicians experienced in performing anorectal procedures who have successfully completed a comprehensive training and certification program in the Solesta injection procedure. It should not be used in patients who have active inflammatory bowel disease, immunodeficiency disorders, previous radiation treatment to the pelvic area, significant rectal prolapse, active infections, bleeding, tumors or malformations in the anorectal area, rectal distended veins, an existing implant in the anorectal region, or allergy to hyaluronic acid based products.

The most common side effects associated with Solesta include injection area pain and bleeding. Infection and inflammation of anal tissue are more serious risks, but are less common.

Solesta is a registered trademark of Q-Med AB of Uppsala, Sweden; Oceana Therapeutics acquired exclusive worldwide sales and distribution rights to Solesta in June 2009. In December 2011 Salix Pharmaceuticals, Ltd. acquired all of the outstanding stock of Oceana Therapeutics, Inc.

Linaclotide (Constella) Available in Europe for Treatment of IBS-C

Linaclotide is the first medicine approved by the European Commission for the symptomatic treatment of moderate to severe irritable bowel syndrome with constipation (IBS-C) in adult patients. It will become available in an increasing number of European countries during 2013 with the EU brand name Constella.

Linaclotide, a guanylate cyclase type-C (GC-C) agonist, is a prescription drug used to relieve symptoms of abdominal pain, discomfort, bloating, and bowel symptoms in people who have IBS-C or chronic constipation (CC). It has been shown to be safe and effective in trials. It works by increasing the amount of fluid that flows into the bowel, allowing stool to pass more easily, and reducing visceral pain. Linaclotide (Linzess) has been available in the U.S. to treat IBS-C and CC in adults aged 18 and older since 2012. Linzess should not be used in patients 17 years of age or younger. Linzess should not be used in patients with known or suspected mechanical gastrointestinal obstruction. The most common side effect reported during clinical studies was diarrhea.

Linaclotide is being co-produced in the U.S. by Ironwood and Forest. Ironwood has out-licensed linaclotide to Almirall, S.A. for development in Europe; and to Astellas Pharma, Inc. for development in Japan, Indonesia, Korea, the Phillipines, Taiwan, and Thailand.

Lubiprostone is Approved by the FDA to Treat Opioid-Induced Constipation

Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceuticals U.S.A. Inc. announced earlier this year that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application for lubiprostone (Amitiza) to treat opioidinduced constipation in adult patients with chronic non-cancer pain. The drug was approved to treat chronic idiopathic constipation (CIC) in adults in 2006 and to treat IBS with constipation (IBS-C) in adult women in 2008.

Amitiza is a prescription drug used to relieve abdominal pain, bloating, and straining and produce softer and more frequent bowel movements in men and women who have CIC. It is also used to treat IBS-C in women who are at least 18 years of age. Amitiza works by increasing the amount of fluid that flows into the bowel and allowing the stool to pass more easily.

The drug met the primary endpoint in a Phase 3 clinical trial for the treatment of opioid-induced bowel dysfunction in patients with chronic, non-cancer pain, excluding those taking methadone. Opioids are narcotics (such as morphine and codeine) used to treat pain. A number of gastrointestinal (GI) symptoms are potential side effects of using opioid-based medications. The most common symptom is constipation. Other symptoms may include decreased gastric emptying, abdominal cramping, spasm, bloating, and delayed-GI transit.

Clinical Trial of Lubiprostone Liquid Formulation for Treatment of Chronic Constipation

The makers of lubiprostone (Amitiza) have announced a randomized, placebocontrolled, double-blinded, multi-center study of a liquid form of lubiprostone in adult subjects with chronic idiopathic constipation (CIC). The trial is expected to enroll 152 patients with CIC at approximately 11 sites in the U.S. A liquid formulation could possibly offer an alternative dosing option for a wider range of patients.

Swiss Prescribing Regulations for Amitiza Relaxed

In early February 2014 it was reported that the Swiss Federal Office of Public Health has lifted several limitations on prescribing Amitiza (lubiprostone) to patients with chronic idiopathic constipation (CIC). The changes make Amitiza more widely available to patients. Patients can now be prescribed Amitiza from all physicians, not just gastroenterologists, and can be using the prescription for up to a year before a prescription review is required.

Medical and Research News

Hospitalizations for Constipation Increasing in Cost and Frequency

New data shows that hospitalizations for constipation are increasing in frequency, and the associated costs are rising. Researchers analyzed the National Inpatient Sample Database for hospital discharge codes related to constipation, from 1997- 2010. This database contains records for over 7 million hospital visits per year.

From 1997 to 2010, discharges with a principal diagnosis of constipation increased by 128.6%. The average hospital charges for these patients increased 239.3% ($8,869 in 1997, adjusted for inflation, to $17,518 in 2010), although the average length of hospital stay only increased from 3.0 to 3.1 days in the same time.

The researchers speculate that the increase in hospitalizations for constipation may be due to the increasing use of medications that cause constipation, and that the cost increase is likely due to the increased number of diagnostic tests performed to test colon function. They conclude that constipation is an escalating burden on the health care system and recommend studies on preventative measures that could reduce this.

New Treatment for IBS with Diarrhea Available for Men in Japan

Ramosetron hydrochloride (HCl) tablets have been approved in Japan for treating IBS-D in males. The drug will be available under the brand name Irribow OD.

Ramosetron HCl is a serotonin 5-HT3 receptor antagonist. It acts on 5-HT3 receptors in the gut to slow intestinal transit and can also reduce transmission of intestinal pain. It is currently only approved for use in select countries including Japan and India, but is under investigation in several other countries.

Positive Phase 3 Trial Results of Eluxadoline in Patients with IBS-D

Two Phase 3 clinical trials evaluating eluxadoline in the treatment of diarrheapredominant irritable bowel syndrome (IBS-D) have shown that the medication helps improve both stool consistency and abdominal pain.

The manufacturer, Furiex Pharmaceuticals, is hoping to file a New Drug Application with the FDA sometime in mid 2014. Eluxadoline has been granted Fast Track status by the FDA, a process designed to facilitate development and expedite the review of drugs to treat diseases with significant unmet medical need.

Study Reports on Metaclopramide Nasal Spray Treatment for Gastroparesis

A Phase 2b study of a new method for treating nausea and vomiting in diabetic gastroparesis seems to show benefit over a traditional form of the treatment.

The study looked at the efficacy and safety of metoclopramide as taken by a new nasalspray delivery method versus by the usual oral tablets.

Delayed gastric emptying symptoms, which are typical of gastroparesis, can interfere with the absorption and efficacy of oral medications. A nasal spray is absorbed through the nasal membrane bypassing the gastric emptying. A Phase 3 study to further investigate the potential of this form of treatment is upcoming.

Probiotic Treatment for IBS Available Over the Counter in Ireland

An over the counter probiotic treatment for IBS is now available in Ireland. The active probiotic culture, Bifidobacterium infantis 35624, was originally discovered at the University College Cork, Ireland in the late 1990s. Since then, it has undergone clinical trials which have validated its efficacy in treating IBS symptoms. This probiotic has already been approved for over the counter use in the US and Canada under the brand name Align, and will be sold under the brand name Alflorex in Ireland.

New Type of Fiber to be Tested in Treating IBS Symptoms

Scientists from two universities are collaborating to develop and test a new type of fiber that may be useful in treating IBS.

The fiber was designed to reduce bloating, a common side effect of current fiber therapies for IBS. It was also designed to break down into a product which helps promote healthy intestinal flora, and to deliver these nutrients farther into the large intestine. Most fibers are broken down in the stomach and small intestine.

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has awarded these researchers a grant to conduct a two-year clinical trial which will test the new fiber. The trial will be starting in early 2014.

FDA Offers New Online Reporting Method for Dietary Supplements

U.S. Food and Drug Administration (FDA) is now accepting online submission of adverse event reports related to the use of dietary supplements. Both mandatory and voluntary adverse event reports may be submitted online.

Reporting of dietary supplement adverse events is important in protecting consumers’ health and safety. The FDA routinely monitors the marketplace. However, with more than 85,000 dietary supplements on the market and no product specific registration requirement, adverse event reporting is invaluable in identifying harmful products.

To submit a dietary supplement adverse event report, visit www.safetyreporting.hhs.gov.

Social Security Announces New Compassionate Allowances Conditions

The Social Security Administration (SSA) announced early this year that they have added 25 new Compassionate Allowances conditions, including chronic intestinal pseudo-obstruction (CIP).

CIP is a rare disorder of gastrointestinal motility where coordinated contractions (peristalsis) in the intestinal tract become altered and inefficient. When this happens, nutritional requirements cannot be adequately met. Pseudo-obstruction in children is usually congenital, or present at birth. It may also be acquired, such as after an illness.

Read more about the symptoms and treatment of CIP

The Compassionate Allowances program expedites disability decisions for Americans with the most serious disabilities to ensure that they receive their benefit decisions within days instead of months or years. Read the full press release at www.ssa.gov/pressoffice/pr/compassionate-allowances-0114-pr.html.

Ondansetron May Ease IBS-D Symptoms

A new study from Garsed and colleagues in the UK suggests that the prescription drug ondansetron (Zofran, Zuplenz) may relieve some of the symptoms of diarrheapredominant IBS (IBS-D). Ondansetron has been in use for many years to decrease nausea and vomiting related to chemotherapy.

In the study, ondansetron was most useful to improve frequent loose stools and urgency in people with mild to moderate symptoms. No significant improvement was seen in abdominal pain. Reportedly, any benefit is usually seen within a few days.

The study was published in the journal Gut in December and is available online at www.gut.bmj.com/content/early/2013/12/12/gutjnl-2013-305989.abstract.

Comprehensive Nonsurgical Treatment Helps Women with Pelvic Floor Dysfunction

Many women suffer from pelvic floor dysfunction (PFD), which can cause a range of symptoms that include bladder and bowel problems, such as constipation or incontinence, as well as pelvic pain.

A retrospective study from the University of Missouri concluded comprehensive pelvic floor rehabilitation, which may include exercises to strengthen or relax the pelvic muscles, biofeedback therapy, constipation management, medications, incontinence devices, and behavioral modification, can help provide relief without surgery.

Existing records from nearly 800 women who had undergone therapy were examined. Those who completed at least five comprehensive rehabilitation sessions reported an average of 80% improvement in urinary incontinence, bowel dysfunction, and pelvic pain. Women who have symptoms of pelvic floor dysfunction are encouraged to discuss their concerns and treatment options with their health care providers.

New Use for Imaging Technique in Treatment of IBS

Researchers at the University of Nottingham, including IFFGD Advisory Board member Robin Spiller, M.D., are studying how Magnetic Resonance Imaging (MRI) can be used to study IBS.

In three new studies, Dr. Spiller and colleagues have used MRIs to study the volume of the colon and how it expands to make space for a meal; the transit time of a meal through the bowel; and how certain food triggers such as fructans and glucose act differently in different parts of the colon.

Their findings will help show how the bowel functions differently between healthy individuals and those with IBS. "In future," says Dr. Spiller, "We will be able to use our MRI techniques to test specific foods to understand how they will affect IBS."

FDA Issues Warning to Consumers on Certain OTC Laxatives

The Food and Drug Administration (FDA) recently issued a warning to consumers that some of the over-the-counter (OTC) laxatives – those called sodium phosphate laxatives – are potentially dangerous if dosing instructions or warnings on the Drug Facts label are not properly followed or when there are certain coexisting health conditions.

The label of sodium phosphate laxatives states that they should be used as one dose per day for no more than three days. If you do not have a bowel movement after taking a dose, you should not take another dose of the product.

FDA is now warning that adults older than 55, and adults and children with certain health conditions or who are using certain other medications – including ibuprofen – should ask their doctor before using these products because they may be at increased risk for harmful side effects. These new warnings are not currently in the Drug Facts label and apply to both adults and children. Read the full FDA update at www.fda.gov/ForConsumers/ ConsumerUpdates/ucm379440.htm.

NIDDK Staff Contributes to Revision of Dietary Guidelines for Americans

Starting this year, researchers and federal staff with diverse expertise, including many with ties to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), have embarked on an endeavor aimed at improving nutrition for all: Updating the Dietary Guidelines for Americans for 2015.

"The Guidelines provide practical, sciencebased advice to help Americans make food and physical activity choices that promote good health, a healthy weight and disease prevention for those ages 2 years and older," said Dr. Van S. Hubbard, director of the NIH Division of Nutrition Research Coordination (DNRC), housed within NIDDK.

More information, including federal dietary guidance and nutrition education resources for children and adults are listed at http://dnrc.nih.gov/education.asp.

NIDDK Unveils Improved Website

After two years of planning, the NIDDK has unveiled an improved website. The new site makes it easier to find grant and research programs, while keeping focus on their easy-to-use health education and education pages. Visit the new site at www.niddk.nih.gov.

"FODMAP Friendly" Food Certification Now Available in Australia

Food products that are low in FODMAPs (which stands for Fermentable Oligosaccharides, Disaccharides, Monosaccharides and Polyols) can now display a certification that identifies them as such in Australia.

The FODMAP Friendly logo was developed by Advanced Accredited Practicing Dietitian Dr. Sue Shepherd and is the first Australian Government-approved labeling system for fructose-friendly and lactose-friendly foods.

FODMAPs are a collection of sugars and related molecules that are found naturally in foods, and can often trigger symptoms of irritable bowel syndrome (IBS).

Read more about FODMAPS

IBS Patients’ Self-Health Ratings Look Beyond GI Symptom Severity

People with IBS tend to base self-ratings of health by including other factors in addition to their IBS symptoms, a recent study suggests. The study looked at a sample of people with moderate to severe IBS, in order to understand how they rate their own health. The resulting self-ratings were correlated more with physical, psychological, and social issues rather than just with their IBS symptom severity. Worse perceptions of health included more severe non-digestive symptoms (such as fatigue), greater psychological distress, and more stressful life circumstances. This finding suggests that improving treatments for IBS requires addressing more than just IBS symptom severity in order to increase an individual’s overall perception of health.

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Last modified on June 18, 2014 at 02:42:06 PM