Efficacy
Data

Trulance provided Tru ReliefTM

In clinical trials of patients with chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C),

There was a significantly greater percentage of efficacy
responders in the Trulance group vs the placebo group1-4

In Study 1 of CIC patients, the percentage of overall efficacy responders* (durable complete spontaneous bowel movement) was 21% for Trulance vs 10% for placebo (P<0.001).1 In Study 3 of IBS-C patients, the percentage of overall efficacy responders* (abdominal pain and stool frequency) was 30% for Trulance vs 18% for placebo (P<0.001).4

MORE

regular, well-formed bowel
movements1,3,4

LESS

IBS-C-related abdominal
pain4

LOW

incidence of diarrhea
(≤5%)1

*In Study 1 of CIC patients, a responder was defined as a patient who had at least 3 complete spontaneous bowel movements in a given week and an increase of at least 1 complete spontaneous bowel movement from baseline in the same week for at least 9 weeks out of the 12-week treatment period and at least 3 of the last 4 weeks of the study. In Study 3 of IBS-C patients, a responder was defined as a patient who met both the abdominal pain intensity and stool frequency responder criteria in the same week for at least 6 of the 12 treatment weeks, which were defined as an abdominal pain intensity responder (a patient who experienced a decrease in the weekly average of worst abdominal pain in the past 24 hours score [measured daily] of at least 30% compared to weekly baseline average) and stool frequency responder (a patient who experienced an increase of at least 1 complete spontaneous bowel movement per week from baseline).1

The efficacy and safety of Trulance was established in 4 clinical trials across 2 indications with more than 3,100 patients1

Trulance was studied in two 12-week, double-blind, placebo-controlled, randomized, multicenter clinical studies in 1,775 adult patients who met Rome III criteria for CIC and were randomized 1:1 to either placebo (n=892) or Trulance 3 mg (n=883) once daily without respect to food. Efficacy was assessed using information provided by patients on a daily basis in an electronic diary.1

Baseline characteristics

Baseline characteristics for patients on Trulance in Study 1 (n=453)2,3

  • Complete spontaneous bowel movements per week

    = 0.3±0.5

  • Spontaneous bowel movements per week

    = 2.0±1.8

  • Stool consistency
    (Bristol Stool Form Scale)§

    = 2.5±1.1

  • Straining score
    (0=none; 4=very severe)||

    = 2.3±0.8

A complete spontaneous bowel movement is a spontaneous bowel movement with the sense of complete evacuation.

A spontaneous bowel movement is a bowel movement that occurs in the absence of laxative use within the previous 24 hours.

§Measured on 7-point Bristol Stool Scale: 1=separate, hard lumps, like nuts (hard to pass); 7=watery, no solid pieces (entirely liquid)

||Straining was reported in Daily Symptom Diary using 5-point Likert Scale: 0=none; 4=very severe

Study 2 is a similar 12-week, double-blind, placebo-controlled, randomized, multicenter clinical study of adult patients who met Rome III criteria for CIC and were randomized 1:1 to either placebo or Trulance 3 mg.2 Patients who were administered Trulance demonstrated similar baseline characteristics for patients on Trulance (n=439), with 0.28±0.55 complete spontaneous bowel movements/week, 1.79±2.05 spontaneous bowel movements/week, a stool consistency of 2.16±1.03, and a straining score of 2.45±0.85.2

Trulance was studied in two 12-week, double-blind, placebo-controlled, randomized, multicenter clinical studies in 1,453 adult patients who met Rome III criteria for IBS-C and received placebo (n=729) or Trulance 3 mg (n=724) once daily without respect to food. Efficacy was assessed using information provided by patients on a daily basis through an electronic phone diary system.1

Baseline characteristics

Baseline characteristics for patients on Trulance in Study 1 (n=351)2,4

  • Complete spontaneous bowel movements per week

    = 0.2±0.5

  • Abdominal pain
    (0=none; 10=worst possible)

    = 5.9±1.7

  • Stool
    consistency§

    = 2.0±0.9

  • Straining (0=none; 10=worst possible)

    = 6.5±1.8

A complete spontaneous bowel movement is a spontaneous bowel movement with the sense of complete evacuation.

§Measured on 7-point Bristol Stool Scale: 1=separate, hard lumps, like nuts (hard to pass); 7=watery, no solid pieces (entirely liquid)

Measured on 11-point numeric rating scale: 0=none; 10=worst possible

Study 2 is a similar 12-week, double-blind, placebo-controlled, randomized, multicenter clinical study of adult patients who met Rome III criteria for IBS-C and were randomized 1:1 to either placebo or Trulance 3 mg. Patients who were administered Trulance demonstrated similar baseline characteristics for patients on Trulance (n=377), with 0.3 (0.5) complete spontaneous bowel movements/week, 6.6 (1.6) abdominal pain, a stool consistency of 1.9 (0.9), and a straining score of 6.8 (1.9).4

Clinical trial results

See how Trulance helped IBS-C and CIC patients across the
following efficacy measures

Trulance produced a durable response1#

In CIC patients, durable response with Trulance was demonstrated vs placebo1,3

Study 1 – Durable overall complete spontaneous bowel movement responders

A responder was defined as a patient who had at least 3 complete spontaneous bowel movements in a given week and an increase of at least 1 complete spontaneous bowel movement from baseline in the same week for at least 9 weeks out of the 12-week treatment period and at least 3 of the last 4 weeks of the study1

Study 2 demonstrated similar numbers of responders for complete spontaneous bowel movement, with 21% (n=430) of patients showing a durable response to Trulance vs 13% (n=440) with placebo.1

#Trulance-treated patients generally returned to baseline for these study endpoints during the post-treatment period.1

Efficacy response with Trulance was sustained over 12 weeks vs placebo1,4

Study 3—Overall efficacy responders (abdominal pain + stool frequency)

Percentage of patients who were overall responders in Study 3. The overall number needed to treat was 10.3 for Trulance.4

Study 4 demonstrated similar numbers of overall efficacy responders: 21% found response on Trulance vs 14% on placebo (P<0.009).1,4

#Trulance-treated patients generally returned to baseline for these study endpoints during the post-treatment period.1

Trulance significantly improved complete spontaneous bowel movement frequency in patients with CIC2,3

CIC

Significant improvement in mean change in complete spontaneous bowel movement frequency to 2.5 per week vs 1.2 for placebo2,3

Study 2 also demonstrated a statistically significant change from baseline for all treatment weeks through Week 12 for Trulance vs placebo, 2.27 vs 1.37 (P<0.001).2

Changes from baseline in weekly complete spontaneous bowel movement frequency. Values are least squares (LS) mean.3

Trulance significantly improved spontaneous bowel movement frequency in patients with CIC

CIC

Significant improvement in spontaneous bowel movement frequency from 2 per week to more than 5 per week2,3

Study 2 demonstrated a statistically significant change from baseline in mean weekly spontaneous bowel movement frequency for all treatment weeks through Week 12 for Trulance vs placebo, 2.59 vs 1.50 (P<0.001).2

Changes from baseline in mean weekly spontaneous bowel movement frequency. Values are LS mean.3

Trulance provided efficacy within 24 hours

In CIC, significantly more patients experienced complete spontaneous bowel movements and spontaneous bowel movements within 24 hours vs placebo2,3

Study 2 demonstrated a statistically significant improvement in the percentage of patients having complete spontaneous bowel movements within 24 hours of the first dose of Trulance vs placebo, 21.4% vs 12.1% (P<0.001).2 Similar results were seen with spontaneous bowel movements within 24 hours of the first dose vs placebo, 43.6% vs 36.4% (P<0.05).2

Trulance significantly improved the number of patients with IBS-C who experienced spontaneous bowel movements within 24 hours vs placebo (P<0.001)2

Study 4 demonstrated a statistically significant improvement in the percentage of patients having spontaneous bowel movements within 24 hours of the first dose of Trulance vs placebo, 41.6% vs 31.4% (P<0.005).2

Trulance significantly improved stool consistency

Trulance helped patients achieve and maintain a mean score of 4 on the Bristol Stool Form Scale (BSFS)3

BSFS stool scores 4.1 (mean) over 12 weeks (%)—Study 13

Study 2 demonstrated a statistically significant change in stool consistency vs placebo as early as Week 1, which remained consistent through Week 12, 1.49 vs 0.87 (P<0.001).2

Stool consistency was measured in weekly BSFS scores; values are LS mean.3

Consistent and significant improvements in stool consistency in both studies vs placebo2,4

cP<0.001 Trulance 3 mg vs placebo. An integrated analysis of IBS-C Studies 3 and 4.

Change from baseline in stool consistency by time point. Values are LS mean ± standard error.4

Trulance significantly improved straining scores

Significant reduction in straining scoresd in patients with CIC2,3

Improvements in straining score were observed early in treatment and were maintained throughout the study, with Trulance significantly reducing straining scores by 40% vs 26% with placebo (P<0.001).3

Study 2 demonstrated significantly less straining in Trulance-treated patients, beginning as early as Week 1 and remaining consistent through Week 12 vs placebo, -0.89 vs -0.61 (P<0.001).2

dStraining was reported in Daily Symptom Diary using 5-point Likert Scale: 0=none; 4=very severe3

Trulance significantly improved straining throughout the treatment period2

dP<0.05 Trulance 3 mg vs placebo. An integrated analysis of IBS-C Studies 3 and 4. The severity of straining during bowel movement was assessed on an 11-point numeric rating scale from 0 (none) to 10 (worst possible).2

Trulance provided significant reduction in IBS-C-related abdominal pain after the first week of treatment2

IBS-C

eP<0.05 Trulance 3 mg vs placebo. An integrated analysis of IBS-C Studies 3 and 4. The severity of abdominal pain was assessed on an 11-point numeric rating scale from 0 (none) to 10 (worst possible).2

Trulance improved abdominal bloating in patients with IBS-C throughout the treatment period2

IBS-C

fP<0.05 for Trulance 3 mg vs placebo. An integrated analysis of IBS-C Studies 3 and 4. The severity of abdominal bloating was assessed on an 11-point numeric rating scale from 0 (none) to 10 (worst possible).2
 

Trulance improved abdominal discomfort in patients with IBS-C throughout the treatment period2

IBS-C

gP<0.05 Trulance 3 mg vs placebo. An integrated analysis of IBS-C Studies 3 and 4. The severity of abdominal discomfort was assessed on an 11-point numeric rating scale from 0 (none) to 10 (worst possible).2
 

Trulance improved abdominal cramping in patients with IBS-C throughout the treatment period2

IBS-C

hP<0.05 Trulance 3 mg vs placebo. An integrated analysis of IBS-C Studies 3 and 4. The severity of abdominal cramping was assessed on an 11-point numeric rating scale from 0 (none) to 10 (worst possible).2
 

Trulance improved abdominal fullness in patients with IBS-C throughout the treatment period2

IBS-C

iP<0.05 Trulance 3 mg vs placebo. An integrated analysis of IBS-C Studies 3 and 4. The severity of abdominal fullness was assessed on an 11-point numeric rating scale from 0 (none) to 10 (worst possible). 2
 

Indication

Trulance (plecanatide) 3 mg tablets is indicated in adults for the treatment of Chronic Idiopathic Constipation (CIC) and Irritable Bowel Syndrome with Constipation (IBS-C).

IMPORTANT SAFETY INFORMATION

WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS
Trulance® is contraindicated in patients less than 6 years of age; in nonclinical studies in young juvenile mice administration of a single oral dose of plecanatide caused deaths due to dehydration. Use of Trulance should be avoided in patients 6 years to less than 18 years of age. The safety and efficacy of Trulance have not been established in pediatric patients less than 18 years of age.

 

Contraindications
  • Trulance is contraindicated in patients less than 6 years of age due to the risk of serious dehydration.
  • Trulance is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction.
Warnings and Precautions
Risk of Serious Dehydration in Pediatric Patients
  • Trulance is contraindicated in patients less than 6 years of age. The safety and effectiveness of Trulance in patients less than 18 years of age have not been established. In young juvenile mice (human age equivalent of approximately 1 month to less than 2 years), plecanatide increased fluid secretion as a consequence of stimulation of guanylate cyclase-C (GC-C), resulting in mortality in some mice within the first 24 hours, apparently due to dehydration. Due to increased intestinal expression of GC-C, patients less than 6 years of age may be more likely than older patients to develop severe diarrhea and its potentially serious consequences.
  • Use of Trulance should be avoided in patients 6 years to less than 18 years of age. Although there were no deaths in older juvenile mice, given the deaths in young mice and the lack of clinical safety and efficacy data in pediatric patients, use of Trulance should be avoided in patients 6 years to less than 18 years of age.
Diarrhea
  • Diarrhea was the most common adverse reaction in the four placebo-controlled clinical trials for CIC and IBS-C. Severe diarrhea was reported in 0.6% of Trulance-treated CIC patients, and in 1% of Trulance-treated IBS-C patients.
  • If severe diarrhea occurs, the health care provider should suspend dosing and rehydrate the patient.
Adverse Reactions
  • In the two combined CIC clinical trials, the most common adverse reaction in Trulance-treated patients (incidence ≥2% and greater than in the placebo group) was diarrhea (5% vs 1% placebo).
  • In the two combined IBS-C clinical trials, the most common adverse reaction in Trulance-treated patients (incidence ≥2% and greater than in the placebo group) was diarrhea (4.3% vs 1% placebo).

Please also see the full Prescribing Information, including BOXED Warning, for additional risk information.