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Severe IBS Symptoms: Clinical Trial results on delivery of peppermint oil to the small intestine through a system (IBgard®)

Reporter: Aviva Lev-Ari, PhD, RN

Written by Freelance medical writer Walter Alexander

IBgard® Delivery of Mint Oil Effective in Patients with Severe IBS Symptoms
WASHINGTON DC, May 17, 2015—In IBSREST™ (Irritable Bowel Syndrome Reduction Evaluation and Safety Trial), sustained delivery of peppermint oil to the small intestine through a system (IBgard®) that minimizes release in the stomach and colon, resulted in significant reductions in severe or unbearable irritable bowel syndrome (IBS) symptoms over four weeks as compared with placebo. Other formulations of mint oil tend to remain in the stomach or pass all the way to the colon, potentially causing cause heartburn, nausea and anal burning.

About 25 percent of IBS patients, said Brooks D. Cash, MD, professor of medicine at University of South Alabama, Mobile, AB, at his poster at the Digestive Disease Week 2015 annual meeting, describe their symptoms as severe. Dr. Cash noted that derangements in gut immunity, microbiota, sensation, motility, secretion, and digestion have all been proposed as possible etiologies of IBS. L-menthol, the main constituent of peppermint oil, has anti-spasmodic, anti-carminative, topical analgesic, anti-infective and 5-HT₃ receptor antagonism properties. IBSREST™ evaluated the efficacy and tolerability of IBgard, an ultra-purified peppermint oil, in a population enriched with severe/unbearable symptoms.High symptom severity reflects higher intensity and frequency of individual symptoms, leading in IBS patients to lower quality of life, work disruptions, and frequent physician visits (more than one per month). Dr. Cash noted also that among treatments for the three IBS subtypes (M:mixed/alternating; D: diarrhea; C:constipation), approved products are lacking for IBS-M and options for IBS-D are limited. “Our study was selective for patients with severe symptoms because that is where the unmet need is,” Dr. Cash said in an interview. He pointed out further that in studies of other treatments, more severe patients tend to respond less well. The targeted delivery of mint oil in solid microspheres to the small intestine was expected to address the unmet need, according to Dr. Cash.

The randomized, placebo-controlled trial included 72 patients (mean age ~41 years) who met Rome III criteria for IBS-D or IBS-M, had average daily IBS-related abdominal pain of ≥4 on a 0-10 scale, and a Total IBS Symptom Score (TISS) of ≥2 on a 0-4 scale. The TISS scale encompasses 8 symptoms (abdominal pain or discomfort, bloating or distention, pain at evacuation, urgency, constipation, diarrhea, mucus or gas and sense of incomplete evacuation). After a 3-week period for symptom severity assessment and prohibited medication washout, subjects were randomly allocated to receive IBgard 180 mg TID or identical placebo for 4 weeks.

After 28 days, the reduction from baseline in number of severe and unbearable symptoms (average of frequency and intensity ≥3) was -66 percent for IBgardas compared with -42 percent with placebo (P=0.0212). The reduction in patient-reported severe or unbearable abdominal pain intensity at 28 days was -79.4 percent for IBgard and-40.5 percent for placebo (P=0.0009). Trends in percent reduction in severe or unbearable individual intensity scores were favorable for IBgard across all 8 severe/unbearable parameters (from 71 percent to 90 percent), more than at 24 hour assessment (30 percent to 47 percent).“Severe symptom patients responded as well as those with less severe symptom patients. That’s very reassuring,” Dr. Cash said.

IBgard was well tolerated and safe. No patients withdrew from the study on account of treatment emergent adverse events.

Dr. Cash concluded, “Over 4 weeks, IBgard was effective at improving the composite IBS symptom score, and the individual IBS symptom components, including severe or unbearable abdominal pain intensity at 4 weeks.”

SOURCE

From: Gail Thornton <gailsthornton@yahoo.com>

Reply-To: Gail Thornton <gailsthornton@yahoo.com>

Date: Wednesday, July 8, 2015 at 11:23 AM

To: Aviva Lev-Ari <avivalev-ari@alum.berkeley.edu>

Subject: Article for Pharmaceutical Business Intelligence on IBgard