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Efficacy Data

Trulance provided Tru Relief with more regular,
well-formed bowel movements and less
IBS-C–related abdominal pain and bloating1-3,a

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

Significant response with Trulance vs placebo1

In Study 3 of adult patients with IBS-C, the percentage of overall efficacy respondersb (abdominal pain and stool frequency) was 30% for Trulance vs 18% for placebo (P<0.001).1,2 In Study 1 of adult patients with CIC, the percentage of overall efficacy respondersb (durable complete spontaneous bowel movement) was 21% for Trulance vs 10% for placebo (P<0.005).1

MORE

regular, well-formed bowel
movements1-4

LESS

IBS-C–related abdominal
pain and bloating1,2,a

LOW

incidence of
diarrhea (≤5%)1

REVIEW EFFICACY DATA REVIEW SAFETY DATA

aMean change from baseline in abdominal symptoms including bloating were measured as a secondary endpoint over 12 weeks in phase III registrational trials.

bIn 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 ≥30% compared with 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 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.1

The efficacy and safety of Trulance was established in 4 clinical trials across 2 indications with more than 3100 patients1

Trulance was studied in two 12-week, double-blind, placebo-controlled, randomized, multicenter clinical studies in 1453 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

Patients included in clinical trials:

Study 3 baseline characteristics for
patients on Trulance (n=349)1

CSBMsc/week5

0.2±0.5

Abdominal pain5,d

5.9±1.7

Stool consistency5,e

2.0±0.9

Bloating5,d

6.4±1.7

cA complete spontaneous bowel movement (CSBM) is a spontaneous bowel movement (SBM) with the sense of complete evacuation; an SBM is a spontaneous bowel movement that occurs in the absence of laxative use within the previous 24 hours.

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

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

Study 4 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. It demonstrated similar baseline characteristics for patients on Trulance (n=375), with 0.3±0.5 CSBMs/week, 6.6±1.6 abdominal pain, a stool consistency of 1.9±0.9, and a bloating score of 6.6±1.7.1,2

Trulance was studied in two 12-week, double-blind, placebo-controlled, randomized, multicenter clinical studies in 1775 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

Patients included in clinical trials:

Study 1 baseline characteristics for
patients on Trulance (n=453)1,5

CSBMsc/week4

0.3±0.5

SBMsf/week4

2.0±1.8

Stool consistency4,e

2.5±1.1

Straining4,g

2.3±0.8

cA complete spontaneous bowel movement (CSBM) is a spontaneous bowel movement (SBM) with the sense of complete evacuation.

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

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

gStraining was reported in Daily Symptom Diary, measured on 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.5 It demonstrated similar baseline characteristics for patients on Trulance (n=443), with 0.28±0.55 CSBMs/week, 1.79±2.05 spontaneous bowel movements/week, a stool consistency of 2.16±1.03, and a straining score of 2.45±0.85.5

Strong recommendation
from ACG Clinical Guidance6

Photo of ACG Guidelines Photo of ACG Guidelines

The 2020 American College of Gastroenterology (ACG) Clinical Guideline gave Trulance, as a GC-C agonist, a strong recommendation with a high quality of evidence for the treatment of global IBS-C symptoms6:

  • Effective for relieving overall and individual symptoms of IBS-C
  • Responses develop quickly and are maintained over time
  • Diarrhea is the most common adverse event experienced, but it is well tolerated, and discontinuation rates due to diarrhea are low

GC-C, guanylate cyclase-C.

Strength of recommendation: Strong=Most patients should receive the recommended course of action.
Quality of evidence: High=The estimate of effect is unlikely to change with new data.6

Clinical trial results

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

Trulance demonstrated a durable response1,h

IBS-C CIC

Durable response with Trulance was demonstrated vs placebo1

Study 1 durable overall CSBM responders1
Bar chart of durable response Bar chart of durable response

There was a significantly greater percentage of efficacy responders (durable CSBM) in the Trulance group than in the placebo group.1

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.1

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

hTrulance-treated patients generally returned to baseline for these study endpoints during the posttreatment period.1

Significant response with Trulance vs placebo1

Study 3 overall efficacy responders (abdominal pain + stool frequency)1,2
Bar chart of durable response Bar chart of durable response

Primary endpoint: 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 score of worst abdominal pain in the past 24 hours [measured daily] of ≥30% compared with weekly baseline average) and stool frequency responder (a patient who experienced an increase of at least 1 CSBM per week from baseline).1

Values are ±95% confidence intervals. The overall number needed to treat was 10.3 for Trulance.1,2

Study 4 demonstrated similar numbers of overall efficacy responders: 22% found response on Trulance vs 14% on placebo (P=0.009).2

In both studies, the proportion of responders who were also weekly responders for at least 2 of the 4 treatment weeks in month 3, the last month of treatment, was greater in the Trulance groups compared to placebo. Abdominal pain was assessed on a rating scale of 0 (none) to 10 (worst possible). A pain responder required a decrease in the worst abdominal pain intensity (WAPI) score of ≥30% compared to weekly baseline average for at least 6 of the 12 treatment weeks.1,2

hTrulance-treated patients generally returned to baseline for these study endpoints during the posttreatment period.1

IBS-C–related abdominal pain: Significant reduction after the first week of treatment sustained through 12-week treatment period5

IBS-C
Line chart of abdominal pain Line chart of abdominal pain

A pain responder required a decrease in the worst abdominal pain intensity (WAPI) score of ≥30% compared with weekly baseline average for at least 6 of the 12 treatment weeks.1,2

The severity of abdominal pain was assessed on an 11-point numeric rating scale from 0 (none) to 10 (worst possible).2

Multiple abdominal symptoms, including bloating: Significant improvement across 12-week treatment period

IBS-C

Trulance improved abdominal bloatingj vs placebo in patients throughout the treatment period5

Line chart of abdominal bloating Line chart of abdominal bloating

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

jMean change from baseline in abdominal symptoms including bloating were measured as a secondary endpoint over 12 weeks in phase III registrational trials.

Trulance improved abdominal cramping vs placebo in patients throughout the treatment period5

Line chart of abdominal discomfort Line chart of abdominal discomfort

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 discomfort vs placebo in patients throughout the treatment period5

Line chart of abdominal cramping Line chart of abdominal cramping

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 fullness vs placebo in patients throughout the treatment period5

Line chart of abdominal fullness Line chart of abdominal fullness

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
 

Trulance delivered results within 24 hours

IBS-C CIC

Significantly more patients experienced CSBMs and SBMs
within 24 hours vs placebo4,5

Bar chart of 24-hour data Bar chart of 24-hour data

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).5

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).5

Significantly improved the number of patients with IBS-C who experienced spontaneous bowel movements within 24 hours vs placebo2

Bar chart of 24-hour data Bar chart of 24-hour data

Trulance significantly improved stool frequency4,5

CIC

Significant improvement in mean change in CSBM frequency—up to 2.5 per week vs 1.2 for placebo4,5

Bar chart of durable response Bar chart of durable response

Changes from baseline in weekly CSBM frequency in Study 1. Values are least squares (LS) mean.4

Study 2 also demonstrated a statistically significant improvement from baseline across the 12-week treatment period for Trulance vs placebo, 2.27 vs 1.37 (P<0.001).5

CIC

Significant increase in SBM frequency—more than 5 per week vs 2 at Trulance baseline4,5

Line chart of bowel frequency Line chart of bowel frequency

Changes from baseline in mean weekly SBM frequency in Study 1. Values are LS mean.4

Study 2 demonstrated a statistically significant change in mean weekly SBM frequency from baseline through week 12 for Trulance vs placebo, 2.59 vs 1.50 (P<0.001).5

Trulance significantly improved stool consistency

IBS-C CIC

Patients on Trulance achieved and maintained a mean score of 4
on the Bristol Stool Form Scale (BSFS)4,7

BSFS mean score for Trulance vs placebo—Study 14,7,r
Line chart of bowel consistency Line chart of bowel consistency

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

Study 2 demonstrated a statistically significant change in stool consistency with Trulance vs placebo as early as week 1, which remained consistent through week 12, 1.49 vs 0.87 (P<0.001).5

Consistent and significant improvements in stool consistency
 in both IBS-C studies vs placebo2,5

Bar chart of stool consistency Bar chart of stool consistency

An integrated analysis of IBS-C Studies 3 and 4.2

Change from baseline in stool consistency by time point. Values are LS mean ± standard error.2

Trulance significantly improved straining scores

IBS-C CIC

Significant reduction in strainingt scores in patients with CIC4,5

Circle chart of straining scores Circle chart of straining scores

Improvements in straining score were observed early in treatment and were maintained throughout the study, with Trulance significantly reducing straining scores by 39% vs 26% with placebo (P<0.001).4

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).5

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

Significantly improved straining scores throughout the treatment period2

Line chart of straining score Line chart of straining score

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

Review Trulance
safety data
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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.