For adults with Chronic Idiopathic Constipation (CIC)

Discover the effect on normalization of CSBM frequency

Motegrity was shown to help normalize complete spontaneous bowel movement frequency
(avg. ≥3 CSBMs/week over 12 weeks) across 5/6 trials1

Select Important Safety Information

Contraindications

  • Hypersensitivity to Motegrity. Reactions including dyspnea, rash, pruritus, urticaria, and facial edema have been observed.
  • Intestinal perforation or obstruction due to structural or functional disorder of the gut wall, obstructive ileus, severe inflammatory conditions of the intestinal tract such as Crohn’s disease, ulcerative colitis, and toxic megacolon/megarectum

Clinical studies

Description
The efficacy of once-daily Motegrity ≤2 mg was evaluated in six double-blind, placebo-controlled, randomized, multicenter clinical trials lasting 12 weeks (Studies 1-5) and 24 weeks (Study 6).1

Patient population
2484 adult patients with CIC (Intent-to-Treat population: Motegrity ≤2 mg [n=1237], placebo [n=1247]). Overall, most patients were female (76%) and Caucasian (76%), with a mean age of 47 ± 16 years (range 17 to 95).1

Primary efficacy endpoint (responders)
Responders defined as proportion (%) of patients with an average of ≥3 CSBMs per week, over the 12-week treatment period, considered a normalization of bowel movement frequency. Efficacy was assessed based on patients' daily diaries.1

Patients averaging at least 3 CSBMs/week over 12 weeks1

Efficacy responder rates evaluated across 6 clinical studies (N=2484)1

Bar chart showing treatment responder rates by clinical study (desktop) Bar chart showing treatment responder rates by clinical study (mobile)

p-values based on a Cochran-Mantel-Haenszel test. Trt Diff=treatment difference; N=patients per treatment group; n=responders; NS=not significant

Across all 6 Studies:

Motegrity demonstrated sustained effect over 12 weeks1

A rapid response with Motegrity was seen as early as week 1, with improvements maintained throughout 12 weeks of treatment.1

RESULTS SEEN:

As early as

Week 1

Sustained through

Week 12

Select Important Safety Information

Warnings and Precautions

Suicidal Ideation and Behavior: In clinical trials, suicides, suicide attempts and suicidal ideation have been reported. A causal association between treatment with Motegrity and an increased risk of suicidal ideation and behavior has not been established. Monitor patients for persistent worsening of depression and emergence of suicidal thoughts and behavior. Instruct patients to discontinue Motegrity immediately and contact their healthcare provider if their depression is persistently worse, or they experience emerging suicidal thoughts or behaviors.

Median time-to-first CSBM and SBM reduced with Motegrity vs. placebo1

7-15 days faster

median time-to-first CSBM1

Patients taking Motegrity had their first CSBM 1.4 to 4.7 days into treatment vs. 9.1 to 20.6 days for those taking placebo (ranges represent median values from 6 studies)1

2.5x
faster

median time-to-first SBM1

Patients taking Motegrity had their first SBM 0.1 to 0.4 days into treatment vs. 1 to 1.6 days for those taking placebo (ranges are median values from 6 studies)1

SBM=spontaneous bowel movement

Alternative Efficacy Endpoint:

Motegrity was also evaluated using a more rigorous endpoint in a post-hoc analysis1

In an alternative efficacy endpoint analysis, a responder was defined as a patient who had at least 3 CSBMs and an increase of at least 1 CSBM from baseline in a given week for at least 9 weeks out of the 12-week treatment period and for at least 3 of the last 4 weeks of the treatment period.1

Study Motegrity
1 or 2 mg Once Daily
placebo Treatment Difference
N n (%) N n (%) (95% CI)
Study 1 249 65 (26) 252 22 (9) 17 (11, 24)
Study 2 177 57 (32) 181 25 (14) 18 (10, 27)
Study 3 236 30 (13) 240 13 (5) 8 (2, 12)
Study 4 190 37 (19) 193 15 (8) 11 (5, 18)
Study 5 214 34 (16) 212 11 (5) 11 (5, 16)
Study 6 171 29 (17) 169 22 (13) 4 (-4, 12)

N=patients per treatment group; n=responders

Additional Endpoint:

Nearly half of Motegrity patients saw improvement in weekly CSBM frequency

In an additional endpoint analysis, a greater % of patients taking Motegrity had a mean increase of ≥1 CSBM/week vs. placebo over the 12-week treatment period (47.0% vs. 29.9%)2

IMPORTANT SAFETY INFORMATION

Contraindications

  • Hypersensitivity to Motegrity. Reactions including dyspnea, rash, pruritus, urticaria, and facial edema have been observed.
  • Intestinal perforation or obstruction due to structural or functional disorder of the gut wall, obstructive ileus, severe inflammatory conditions of the intestinal tract such as Crohn’s disease, ulcerative colitis, and toxic megacolon/megarectum

Warnings and Precautions

Suicidal Ideation and Behavior: In clinical trials, suicides, suicide attempts and suicidal ideation have been reported. A causal association between treatment with Motegrity and an increased risk of suicidal ideation and behavior has not been established. Monitor patients for persistent worsening of depression and emergence of suicidal thoughts and behavior. Instruct patients to discontinue Motegrity immediately and contact their healthcare provider if their depression is persistently worse, or they experience emerging suicidal thoughts or behaviors.

Adverse Reactions

Most common adverse reactions (≥2%) are headache, abdominal pain, nausea, diarrhea, abdominal distension, dizziness, vomiting, flatulence, and fatigue.

Use in Specific Populations

  • Lactation: Motegrity is present in breast milk. Consider risks and benefits of breastfeeding
  • Pediatric: Safety and effectiveness in pediatric patients have not been established
  • Renal Impairment: A decreased dosage is recommended in patients with severe renal impairment. Avoid Motegrity in patients with end-stage renal disease requiring dialysis

Indication

Motegrity is indicated for the treatment of chronic idiopathic constipation (CIC) in adults.

Please click here for full Prescribing Information.

References:

1. Motegrity (prucalopride) Prescribing Information. Lexington, MA: Shire LLC. 2. Camilleri M, Piessevaux H, Yiannakou Y, et al. Dig Dis Sci. 2016;61(8):2357-2372.