IBSRELA: Demonstrated Effective, Rapid, and Sustained Response1,2

Primary Endpoint:
Overall Responders CSBMs Abdominal Pain Abdominal Symptoms Quality of Life
Primary Endpoint:
Overall Responders

IBSRELA Has Been Evaluated in Two Phase 3 Clinical Trials With Over 1,200 Adult Patients With IBS-C1-3

T3MPO-1 (N=606) and T3MPO-2 (N=620) were multicenter, double-blind trials of adults who met the Rome III Diagnostic Criteria for IBS-C randomized to receive IBSRELA 50 mg BID or placebo twice daily. The primary efficacy endpoint was the overall response for 6 or more of the first 12 treatment weeks.1-3

  • T3MPO-1: 12 weeks followed by a 4-week randomized withdrawal period. 27% of IBSRELA-treated patients were overall responders, resulting in a placebo-adjusted difference of 8% (P=0.020)3
  • T3MPO-2: 26 weeks with primary endpoint measurement through week 12. 36.5% of patients treated with IBSRELA were overall responders, resulting in a placebo-adjusted difference of 13% (P<0.001). See baseline characteristics2,4

Rome III Diagnostic Criteria: Recurrent abdominal pain or discomfort at least 3 days per month in the last 3 months associated with 2 or more of the following: 1. Improvement with defecation; 2. Onset associated with a change in frequency of stool; 3. Onset associated with a change in form (appearance) of stool. Criteria must have been fulfilled for the last 3 months, with symptom onset at least 6 months prior to diagnosis.5

T3MPO-2 primary endpoint

Significantly More IBSRELA-Treated Patients Were Overall Responders Compared With Placebo2

Responder Endpoints Through Week 122

IBSRELA vs placebo, overall responders graph

36.5%

of IBSRELA-treated patients were overall responders2‡

Primary efficacy endpoint: overall response for 6 or more of the first 12 treatment weeks.
CSBMs defined as spontaneous bowel movements (unaided) accompanied by a sensation of complete evacuation.
‡Overall responder defined as: decrease in average weekly worst abdominal pain of greater than or equal to 30.0% from baseline AND an increase of at least one CSBM from baseline, both in the same week, for at least 6 of the first 12 weeks of treatment.

Efficacy of Tenapanor in Treating Patients With Irritable Bowel Syndrome With Constipation: A 12-Week, Placebo-Controlled Phase 3 Trial (T3MPO-1)

View publication

Efficacy of Tenapanor in Treating Patients With Irritable Bowel Syndrome With Constipation: A 26-Week, Placebo-Controlled Phase 3 Trial (T3MPO-2)

View publication
CSBMs Abdominal Pain Abdominal Symptoms Quality of Life

Peer Perspectives

“The data presented are clinically relevant for our patients given the magnitude of improvement, a quick onset of action, and the sustained effect over time seen for both abdominal symptoms and CSBMs.”

—Dr Brian E Lacy

Compensated advisor to Ardelyx

Video: IBSRELA: Key Clinical Data from T3MPO-2 - Dr Brian E Lacy

IBSRELA: Different mechanism of action. Different class of therapy1

See MOA

Review IBSRELA safety data

See safety

References:

1. IBSRELA [prescribing information]. Waltham, MA: Ardelyx, Inc.; 2022. 2. Chey WD, Lembo AJ, Yang Y, Rosenbaum DP. Efficacy of tenapanor in treating patients with irritable bowel syndrome with constipation: a 26-week, placebo-controlled phase 3 trial (T3MPO-2). Am J Gastroenterol. 2021;116(6):1294-1303. 3. Chey WD, Lembo AJ, Rosenbaum DP. Efficacy of tenapanor in treating patients with irritable bowel syndrome with constipation: a 12-week, placebo-controlled phase 3 trial (T3MPO-1). Am J Gastroenterol. 2020;115(2):281-293. 4. Data on file. Ardelyx, Inc. 2018. 5. Longstreth GF, Thompson WG, Chey WD, Houghton LA, Mearin F, Spiler RC. Functional bowel disorders. Gastroenterology. 2006;130(5):1480-1491.

INDICATION

IBSRELA (tenapanor) 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.

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%).

Please see full Prescribing Information, including Boxed Warning, for additional risk information.