Ardelyx Presents Positive Data at DDW 2023 on IBSRELA® (tenapanor), a First-In-Class Treatment for IBS-C in Adults
IBSRELA provides meaningful reduction of multiple abdominal symptoms
Patient-reported outcomes are strongly correlated with IBS-C abdominal symptom score
“Abdominal symptoms of IBS-C, including pain, bloating and discomfort, can have an extremely negative impact on patients’ quality of life,” said
Ardelyx Poster #Tu1618, entitled “Analysis of Patient-Reported Treatment Satisfaction and Abdominal Score in Patients with Irritable Bowel Syndrome with Constipation (IBS-C) with Tenapanor,” reported results from a post hoc analysis of the T3MPO-2 study of IBSRELA in adult patients with IBS-C to examine the relationship between patient-reported satisfaction (as measured by adequate relief and degree of relief) and improvement in abdominal symptoms. The Phase 3 T3MPO-2 study randomized patients to tenapanor 50 mg twice a day or matched placebo for 26 weeks of treatment. The analysis demonstrated that IBSRELA meaningfully reduced multiple abdominal symptoms in patients with IBS-C, including bloating, discomfort and pain, compared to placebo. The analysis also indicates that patient-reported treatment satisfaction was strongly correlated with the IBS-C abdominal score (AS3, combining mean weekly abdominal pain, bloating and discomfort scores) and could be a useful tool to assess clinically meaningful improvements in adult patients with IBS-C.
Poster presentations are now publicly available and can be accessed on demand HERE.
IBSRELA (tenapanor) 50mg BID is indicated for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in adults.
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%).
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.
Investor and Media Contacts:
Source: Ardelyx, Inc.