OTC IBgard Reduces Short-Term IBS Symptoms in Study

In a study presented at Digestive Disease Week (DDW), non-prescription IBgard led to a reduction in symptoms associated with irritable bowel syndrome (IBS), including unbearable and severe symptoms and abdominal pain intensity.

The randomized controlled double-blind multi-center study, the Irritable Bowel Syndrome Reduction Evaluation and Safety Trial (IBSREST), assigned 72 patients aged 18–60 with symptoms of IBS, mixed diarrhea and constipation (IBS-M) and IBS, diarrhea predominant (IBS-D) and Rome III criteria for IBS-M or IBS-D to two capsules of IBgard (90mg peppermint per capsule) three times per day or placebo. Patients were required to undergo lab testing prior to enrollment and washout of prohibited medications. The primary outcomes were changes in Total IBS Symptom Score (TISS) at 24 hours and four weeks.

A total of 18.8% of patients receiving IBgard reported a reduction in TISS from baseline at 24 hours and 39.6% at four weeks. Thirty percent of patients experienced a reduction in unbearable or severe symptoms from baseline at 24 hours and 66% reduction at four weeks. For patient-reported unbearable or severe abdominal pain intensity, 45.7% reported a reduction at 24 hours and 79.4% at four weeks.

IBgard capsules contain L-menthol, the principal component in peppermint oil and utilize novel SST technology to deliver L-menthol to the small intestine. While IBgard is available over-the-counter, it should be used under medical supervision. The product is expected to launch in June 2015 at most CVS and Walgreens stores nationwide.

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