Ardelyx Showcased Encouraging Data on Treatment Satisfaction and Efficacy of IBSRELA® (tenapanor) for IBS-C at GHAPP 2023
“IBS-C can be incredibly challenging to manage and can significantly disrupt the quality of life for many patients who experience multiple symptoms, including abdominal pain, bloating and discomfort. There is a growing body of data that continues to expand our understanding of IBSRELA and how it works to provide symptomatic relief. These data provide additional evidence of IBSRELA’s safety and efficacy, bringing much needed relief to those living with IBS-C,” said
The first poster presented, Analysis of Patient-Reported Treatment Satisfaction and Abdominal Score in Patients with Irritable Bowel Syndrome with Constipation (IBS-C) Treated with Tenapanor, which was previously presented at the 2023
The second poster presented at GHAPP, A Subgroup Efficacy Analysis in Patients with IBS-C from the Tenapanor Phase 3 Studies, reported results from a pooled analysis from the T3MPO-1 and T3MPO-2 trials of IBRSELA in adult patients with IBS-C which evaluated patients based on baseline characteristics including abdominal pain severity, sex, age and race to better understand efficacy across these subgroups. Patients were randomized to tenapanor 50 mg twice per day or placebo for 12 weeks in T3MPO-1 and for 26 weeks in T3MPO-2. The post hoc pooled analysis found that a higher proportion of patients randomized to tenapanor versus placebo had a durable complete spontaneous bowel movement (CSBM) response. Additionally, for most subgroups, a higher proportion of patients randomized to tenapanor versus a placebo had an early CSBM and spontaneous bowel movement (SBM) response. The analysis also indicated that the results were not affected by a variety of patient characteristics, including age, race, sex and those with differing baseline abdominal pain severity scores.
IMPORTANT SAFETY INFORMATION
|WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS|
|IBSRELA 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.|
- 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 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%).
IBSRELA (tenapanor) is indicated for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in adults.
Please see full Prescribing 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
About IBSRELA for IBS-C
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.
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Source: Ardelyx, Inc.