(NASDAQ: FURX) today announced top-line results indicating the company’s two pivotal Phase III clinical trials evaluating the efficacy and safety of eluxadoline in the treatment of diarrhea-predominant irritable bowel syndrome (IBS-d) met both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) formally agreed-upon primary endpoints of composite response based on simultaneous improvements in stool consistency and abdominal pain. These endpoints are aligned with both the current FDA guidance and the 2013 EMA draft guidance for clinical trial evaluation of new medicines for irritable bowel syndrome. “I am very pleased with the strength of the data, and proud of our team for its hard work and excellent development of eluxadoline,” said Fred Eshelman, founding chairman of Furiex. “In just under four years, working closely with regulatory authorities, the team has completed nine Phase I studies, a Phase II dose-ranging trial in approximately 800 patients, and these two large Phase III trials. Additionally, we have completed all toxicology studies and believe we are on schedule, including chemistry and manufacturing work, for an NDA submission by the end of the second quarter of 2014.” The studies, known as 3001 and 3002, were randomized, double-blind, placebo-controlled studies in which patients received eluxadoline, 75 mg twice-daily (BID), eluxadoline 100 mg BID or placebo BID. A total of 2,428 subjects were enrolled across the two studies. The primary efficacy endpoint was a composite response evaluated over the initial 12 weeks of double-blind treatment for FDA evaluation, and over the 26 weeks of double-blind treatment for EMA evaluation. Response rates were compared based on patients who met the daily composite response criteria (improvement in pain and stool consistency) for at least 50% of the days from weeks 1 to 12 and weeks 1 to 26. A patient must have met both of the following criteria on any given day to be a daily responder: Daily stool consistency response: Bristol stool score <5, or the absence of a bowel movement; and Daily pain response: worst abdominal pain scores in the past 24 hours improved by 30% compared to baseline (average of week prior to randomization). "We are pleased with these top-line results, which put us one step closer to filling an unmet medical need in men and women with IBS-d," said June Almenoff, M.D., Ph.D., president and chief medical officer of Furiex. "In addition to showing both rapid onset and durable efficacy of the primary endpoints, both pivotal studies demonstrated robust efficacy for the secondary endpoint of adequate relief of IBS symptoms. We look forward to further analyzing the data and plan to present details at an upcoming medical conference." 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. Source:Furiex Pharmaceuticals, Inc.
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New Imaging Technique Brings Irritable Bowel Syndrome Treatment Close to Reality
According to a 2012 review in Clinical and Experimental Gastroenterology, IBS is believed to stem from an interaction among altered intestinal activity, a heightened sensitivity to intestinal pain and certain environmental stressors. In people with diarrhea-predominant IBS, or IBS-D, intestinal activity appears to be accelerated. You Might Also Like How to Relieve IBS Serotonin Blockade Serotonin is an important chemical messenger in your nervous system and gastrointestinal tract. When serotonin stimulates receptors in your intestinal wall, intestinal motion increases, and more fluid is secreted into the interior of your bowel. These actions lead to cramping and more frequent bowel movements or even diarrhea. IBS-D is believed to result, in part, from heightened intestinal sensitivity to serotonin, a concept that has led to the development of medications that block serotonins actions. Currently, alosetron (Lotronex) is the only serotonin blocker licensed for treating IBS-D in the U.S. Due to potentially serious side effects, such as decreased intestinal blood flow, alosetron is available only through special prescribing programs. Antidepressants Due to their tendency to slow bowel activity, tricyclic antidepressants have found a place in the treatment of diarrhea-predominant IBS. Among these agents, amitriptyline (Elavil), imipramine (Tofranil) and desipramine (Norpramin) have been tested in clinical trials and have been shown to improve symptoms in patients with IBS-D. The doses required to relieve IBS symptoms are often below those needed to control depression, which may help to limit the dry mouth, dizziness and fatigue that are sometimes associated with tricyclic antidepressants. Intestinal Bacteria A number of studies have suggested a link between IBS symptoms and alterations in intestinal bacteria. Treatments designed to normalize the bacterial populations in your gastrointestinal tract may relieve some of the bloating, gas and cramping associated with IBS-D.
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Diarrhea-Predominant Irritable Bowel Syndrome
In three separate studies, the researchers examined the effectiveness of using MRI to study the colon, which has a number of unique advantages. Previously, doctors have relied on x-rays to view the colon, which has limitations due to the risks associated with radiation. By using MRI as an alternative, the researchers have been able to image the bowel continuously with no risk to the patient, enabling them to learn more about the inner workings of the gut. In the first study scientists studied people with accelerated transit and found that the colon size was rather similar to those with normal transit, suggesting people regulate their bowel habit to keep the colonic size constant. In the second paper scientists used MRI to measure the actual time it takes for contents to transit the bowel, using specially designed MRI visible markers which subjects ingest. The researchers said the use of x-rays in this type of procedure is undesirable for children or young women of child rearing age- which is unfortunate as both of these groups can suffer with bowel function that may need investigating. So developing this alternative method of examination has particular appeal, particularly in children- who tend to suffer with a wide range of bowel problems. In the third study, researchers used the colonic imaging technique again, but this time, to improve their understanding of the causes of IBS. By looking at fructose, a sugar commonly found in fruit, and fructans, which are polymers of fructose, researchers were able see what effects these had on the gut of healthy volunteers. “We already know that fructose is difficult to absorb, but the novelty with this new method, is that we are now able to image the end effect of this mal-absorption which is the distension of the small intestine and colon. We are currently repeating these studies in patients with IBS to see whether their symptoms correlate with the distension of the colon,” Professor Robin Spiller said. The study was published in American Journal of Gastroenterology. More News on: I agree to the terms and conditions Your comments are automatically posted once they are submitted. All comments are however constantly reviewed for spam and irrelevant material (such as product or personal advertisements, email addresses, telephone numbers and website address). Such insertions do not conform to our policy and ‘Terms of Use’ and are either deleted or edited and republished. Please keep your comments brief and relevant.This section may also have questions seeking help.
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