In Two Phase 3 Trials (T3MPO-1 and T3MPO-2) With Over 1200 Adult Patients With IBS-C

IBSRELA DEMONSTRATED EFFECTIVE, RAPID, AND SUSTAINED RESPONSE1

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

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36.5%of patients treated with IBSRELA were overall responders‡

‡Primary efficacy endpoint: overall response for 6 or more of the first 12 treatment weeks.

‡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 complete spontaneous bowel movement (CSBM) from baseline, both in the same week, for at least 6 of the first 12 weeks of treatment.

View the study design

Study Design of T3MPO-2

  • Multicenter, randomized, double-blind, placebo-controlled trial1
  • Included 620 adults who met the Rome III Diagnostic Criteria for IBS-C1
  • Patients were randomized to receive IBSRELA 50 mg BID or placebo BID (for 26 weeks)1,2

*ITT analysis set.

*CSBMs defined as spontaneous bowel movements (unaided) accompanied by a sensation of complete evacuation.
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.4

IBSRELA Reduced Abdominal Pain as Early as Week 1 With Sustained Efficacy Over Time2

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54%improvement in abdominal pain scores among IBSRELA-treated patients at Week 263

IBSRELA-TREATED PATIENTS HAD A MEAN ABDOMINAL PAIN SCORE OF 6.3 AT BASELINE AND 2.9 AT WEEK 26

*Severity of abdominal pain was assessed on an 11-point scale, where 0 represents no pain and 10 represents very severe pain. The average weekly worst abdominal pain scores were calculated as the average score for all days during a valid week. If a patient did not have data reported for at least 4 days during a given week (either due to a gap in reporting or due to discontinuation), the patient was considered to be a nonresponder for the week. Scores reported in the intent-to-treat analysis set.

View the study design

Study Design of T3MPO-2

  • Multicenter, randomized, double-blind, placebo-controlled trial1
  • Included 620 adults who met the Rome III Diagnostic Criteria for IBS-C1
  • Patients were randomized to receive IBSRELA 50 mg BID or placebo BID (for 26 weeks)1,2

*ITT analysis set.

*CSBMs defined as spontaneous bowel movements (unaided) accompanied by a sensation of complete evacuation.
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.4

In T3MPO-2, IBSRELA Reduced Bloating and Other Abdominal Symptoms as Early as Week 1 With Sustained Efficacy Over Time3

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Severity of symptoms (bloating, fullness, abdominal discomfort, and cramping) was assessed on an 11-point scale, where 0 represents no symptoms and 10 represents very severe symptoms. The average weekly abdominal symptom scores were calculated as the average score for all days during a valid week. If a patient did not have data reported for at least 4 days during a given week (either due to a gap in reporting or due to discontinuation), the patient was considered to be a nonresponder for the week. Scores reported in the intent-to-treat analysis set. All symptoms had a significant reduction when compared with placebo; P<0.05.

View the study design

Study Design of T3MPO-2

  • Multicenter, randomized, double-blind, placebo-controlled trial1
  • Included 620 adults who met the Rome III Diagnostic Criteria for IBS-C1
  • Patients were randomized to receive IBSRELA 50 mg BID or placebo BID (for 26 weeks)1,2

*ITT analysis set.

*CSBMs defined as spontaneous bowel movements (unaided) accompanied by a sensation of complete evacuation.
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.4

IBSRELA Improved CSBMs as Early as Week 1 With Sustained Efficacy Over Time2

data visualization
On average, over the 26-week treatment period, patients treated with IBSRELA achieved 3.3 CSBM
s
per week3

This CSBM frequency falls within the healthy range for adults2

*CSBMs defined as spontaneous bowel movements (unaided) accompanied by a sensation of complete evacuation. The CSBM response criterion was defined as an increase of 1 or more in average weekly CSBMs from baseline. Scores reported in the intent-to-treat analysis set.

View the study design

Study Design of T3MPO-2

  • Multicenter, randomized, double-blind, placebo-controlled trial1
  • Included 620 adults who met the Rome III Diagnostic Criteria for IBS-C1
  • Patients were randomized to receive IBSRELA 50 mg BID or placebo BID (for 26 weeks)1,2

*ITT analysis set.

*CSBMs defined as spontaneous bowel movements (unaided) accompanied by a sensation of complete evacuation.
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.4

In T3MPO-2, the Vast Majority of Patients Treated With IBSRELA Were Satisfied With Treatment3,*

data visualization
81%of patients reported being moderately satisfied or better

*Treatment satisfaction was assessed on a numerical scale from 1 to 5 (1 = not at all satisfied, 2 = a little satisfied, 3 = moderately satisfied, 4 = quite satisfied, 5 = very satisfied). Treatment satisfaction was recorded at the end of each month during the treatment period through Week 20 and then again at Week 26.

View the study design

Study Design of T3MPO-2

  • Multicenter, randomized, double-blind, placebo-controlled trial1
  • Included 620 adults who met the Rome III Diagnostic Criteria for IBS-C1
  • Patients were randomized to receive IBSRELA 50 mg BID or placebo BID (for 26 weeks)1,2

*ITT analysis set.

*CSBMs defined as spontaneous bowel movements (unaided) accompanied by a sensation of complete evacuation.
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.4

In T3MPO-2, Patients Treated With IBSRELA Reported Improvement in Quality of Life3

Increase in Overall QoL Score at the End of Treatment Compared With Baseline in T3MPO-2

data visualization
41%IMPROVEMENT IN QUALITY OF LIFE (Q
o
L) SCORE FROM BASELINE TO END OF TREATMENT IN IBSRELA-TREATED PATIENTS

*At Week 26, QoL scores were considerably higher compared with placebo; P=0.011.

*Quality of life was assessed using the IBS-QoL, a 34-question instrument that measures 8 subscales relevant to patients with IBS: dysphoria, interference with activity, body image, health worry, food avoidance, social reaction, sexual relationships, and overall quality of life.

View the study design

Study Design of T3MPO-2

  • Multicenter, randomized, double-blind, placebo-controlled trial1
  • Included 620 adults who met the Rome III Diagnostic Criteria for IBS-C1
  • Patients were randomized to receive IBSRELA 50 mg BID or placebo BID (for 26 weeks)1,2

*ITT analysis set.

*CSBMs defined as spontaneous bowel movements (unaided) accompanied by a sensation of complete evacuation.
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.4

Explore IBSRELA

See the  Safety data

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. Data on file. Ardelyx, Inc. 2018.
  4. Longstreth GF, Thompson WG, Chey WD, et al. Functional bowel disorders. Gastroenterology. 2006;130(5):1480-1491.

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%).

INDICATION

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.

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