Ardelyx, Inc. announced that they will share positive data on IBSRELA® (tenapanor) via an oral presentation and two posters at the American College of Gastroenterology annual meeting, being held October 20 to 25 in Vancouver, Canada. IBSRELA, discovered and developed by Ardelyx, is a first-in-class treatment that is currently approved by the U.S. Food and Drug Administration to treat irritable bowel syndrome with constipation (IBS-C) in adults. The oral presentation, titled Tenapanor Treatment Success for IBS-C Symptoms Increases with Duration of Therapy led by Dr. Brian E. Lacy, Dr. Yang Yang and Dr. David P. Rosenbaum, will share findings from a pooled analysis of the phase 2b and phase 3 T3MPO studies of IBSRELA in adult patients.

These studies looked at the effects of the drug on abdominal pain and other IBS-C symptoms. The new post-hoc data presented evaluate the time to onset of tenapanor effect on bowel function and abdominal symptoms in adult patients with IBS-C. The researchers concluded that these patients experience a relatively quick onset of symptom relief under tenapanor treatment and that weekly response rates continued to increase with treatment duration. The first poster to be presented at the ACG meeting, titled Tenapanor Can Improve Abdominal Symptoms Independent of Changes in Bowel Movement Frequency in Adult Patients with IBS-C, also looks at data from the T3MPO studies to examine effects on abdominal pain and abdominal score 3 (AS3), independent of changes in bowel functions over the first 12 weeks of the study. The data showed that tenapanor improved abdominal symptoms regardless of improvement in complete solid bowel movements (CSBMs) in adult patients with IBS-C and that improvement in abdominal symptoms without improvement in CSBMs may be a result of tenapanor?s novel mechanism of action that has been shown to reduce both intestinal permeability and visceral hypersensitivity in nonclinical studies.

The second poster, Improvement in Bloating and Overall Complete Spontaneous Bowel Movement Response with Tenapanor Treatment: A Post Hoc Analysis of the IBS-C Clinical Studies, analyzes data from the T3MPO studies to assess the relationship between improvement in bloating and overall CSBM response in patients treated with tenapanor. This analysis concluded that patients with tenapanor demonstrated a marked improvement in average weekly bloating score, and that patients who had an overall CSBM response had a greater improvement in bloating than those who did not. CONTRAINDICATIONS IBSRELA is contraindicated in patients less than 6 years of age due to the risk of serious dehydration.

IBSRELA is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. WARNINGS AND PRECAUTIONS Risk 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. Diarrhea Diarrhea 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 REACTIONS The 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%). INDICATION IBSRELA (tenapanor) is indicated for the treatment of irritable bowel syndrome with Constipation (IBS-C) in adults.