Tenapanor shows promise in Irritable bowel syndrome in phase 3 trials: claims study
Irritable bowel syndrome (IBS) is a chronic symptom-based disorder characterized by abdominal pain and altered bowel movements . Symptoms of IBS can cause considerable morbidity, impair quality of life, and impact work productivity . The financial burden of IBS is comparable with other common chronic diseases of similar prevalence, including asthma, migraine, and congestive heart failure.
Tenapanor is a first-in-class, minimally absorbed, small-molecule inhibitor of the gastrointestinal sodium/hydrogen exchanger isoform 3.
In a recent phase 3 trial recently published in The American Journal of Gastroenterology, researchers assessed the efficacy and safety of tenapanor 50 mg b.i.d. for the treatment of patients with constipation-predominant irritable bowel syndrome.
This multicenter, phase 3, randomized, double-blind, placebo-controlled study enrolled patients from 92 sites in the United States between November 2015 and March 2017 (last patient randomized on December 1, 2016). After a 2-week screening period, eligible patients were randomly assigned to receive tenapanor hydrochloride (hereafter referred to as tenapanor) 50 mg b.i.d. or placebo b.i.d. for 12 weeks. Patients were instructed to take 1 tablet immediately before breakfast or the first meal of the day and another tablet immediately before dinner.
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