Ardelyx Announces Publication of a Review Article Exploring the Patient Burden and Therapeutic Landscape of IBS-C in the U.S. in Clinical and Experimental Gastroenterology
ARDX 10.09.2024
The article provides an overview of treatment options and disease management for irritable bowel syndrome with constipation (IBS-C) from a
“IBS-C patients often experience a high level of disease burden across a variety of factors which extend beyond the physical symptoms associated with the condition. Patients often report negative economic, social and mental health impacts due to IBS-C, which makes even daily activities challenging,” said
The authors review the substantial societal burden in terms of health care costs, opportunity costs and decreased quality of life that comes with IBS-C. The article also reviews the treatment journey a patient with IBS-C may experience, beginning with lifestyle interventions and nonpharmacologic options, with progression to a
The article is available online and can be accessedhere.
About IBSRELA® (tenapanor)IBSRELA (tenapanor) is a locally acting inhibitor of the sodium/hydrogen exchanger 3 (NHE3), an antiporter expressed on the apical surface of the small intestine and colon primarily responsible for the absorption of dietary sodium. By inhibiting NHE3 on the apical surface of the enterocytes, tenapanor reduces absorption of sodium from the small intestine and colon, thus retaining luminal water content, which accelerates intestinal transit time and results in a softer stool consistency. IBSRELA has also been shown to reduce abdominal pain by decreasing visceral hypersensitivity and by decreasing intestinal permeability in animal models. In a rat model of colonic hypersensitivity, tenapanor reduced visceral hyperalgesia and normalized colonic sensory neuronal excitability. Please see fullPrescribing Information, including Boxed Warning, for additional risk information.
About Irritable Bowel Syndrome with Constipation (IBS-C)Irritable bowel syndrome with constipation (IBS-C) is a gastrointestinal disorder characterized by both abdominal pain and altered bowel movements, estimated to affect 12 million people in the
IMPORTANT SAFETY INFORMATION
| WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTSIBSRELA is contraindicated in patients less than 6 years of age; in nonclinical studies in young juvenile rats administration of tenapanor caused deaths presumed to be due to dehydration. Avoid use of IBSRELA in patients 6 years to less than 12 years of age. The safety and effectiveness of IBSRELA have not been established in patients less than 18 years of age. |
CONTRAINDICATIONSIBSRELA is contraindicated in:
- patients less than 6 years of age due to the risk of serious dehydration
- patients with known or suspected mechanical gastrointestinal obstruction
WARNINGS AND PRECAUTIONSRisk of Serious Dehydration in Pediatric Patients
- IBSRELA is contraindicated in patients below 6 years of age. The safety and effectiveness of IBSRELA in patients less than 18 years of age have not been established. In young juvenile rats (less than 1 week old; approximate human age equivalent of less than 2 years of age), decreased body weight and deaths occurred, presumed to be due to dehydration, following oral administration of tenapanor. There are no data available in older juvenile rats (human age equivalent 2 years to less than 12 years).
- Avoid the use of IBSRELA in patients 6 years to less than 12 years of age. Although there are no data in older juvenile rats, given the deaths in younger rats and the lack of clinical safety and efficacy data in pediatric patients, avoid the use of IBSRELA in patients 6 years to less than 12 years of age.
DiarrheaDiarrhea was the most common adverse reaction in two randomized, double-blind, placebo-controlled trials of IBS-C. Severe diarrhea was reported in 2.5% of IBSRELA-treated patients. If severe diarrhea occurs, suspend dosing and rehydrate patient.
MOST COMMON ADVERSE REACTIONSThe most common adverse reactions in IBSRELA-treated patients (incidence ≥2% and greater than placebo) were: diarrhea (16% vs 4% placebo), abdominal distension (3% vs <1%), flatulence (3% vs 1%) and dizziness (2% vs <1%).
INDICATIONIBSRELA (tenapanor) is indicated for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in adults.
Please see fullPrescribing Information, including Boxed Warning, for additional risk information.
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Source: Ardelyx, Inc.