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

Motegrity 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

People icon
Study Design
Patient demographics &
baseline characteristics

Patients averaging at least 3 CSBMs/week over 12 weeks1

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

p<0.001
10%(N=252;
n=26)
33%(N=249;
n=83)
p<0.001
18%(N=181;
n=32)
38%(N=177;
n=67)
p<0.002
10%(N=240;
n=23)
19%(N=236;
n=46)
p<0.001
13%(N=193;
n=25)
29%(N=190;
n=55)
p<0.001
12%(N=212;
n=25)
24%(N=214;
n=50)
NSp<0.341 NS
20%(N=169;
n=34)
25%(N=171;
n=43)

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

Interested in receiving samples of Motegrity?

Your patients can benefit from a trial. Order a 7-day sample to get started.

package
Bitmap cropped
Request Samples

ACROSS ALL 6 STUDIES:

Motegrity (prucalopride) 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

Arrow

Sustained through

Week 12

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 frequency2

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

Bottle icon

Request Samples

Interested in receiving
samples of Motegrity?

Request samples
Map icon

Formulary Coverage

Wondering which plans in your area cover Motegrity? See our patient access coverage tool to find out more.

Patient access coverage tool

IMPORTANT SAFETY INFORMATION

Expand Collapse

Please expand for Indication and 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. Postmarketing cases of suicidal ideation and behavior as well as self-injurious ideation and new onset or worsening of depression have been reported within the first few weeks of starting Motegrity. A causal association between treatment with Motegrity and an increased risk of suicidal ideation and behavior has not been established. Monitor patients for new onset or worsening of depression and emergence of suicidal thoughts and behavior. Instruct patients to discontinue Motegrity immediately and contact their healthcare provider if they experience any of these symptoms.

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® (prucalopride) is a serotonin-4 (5-HT4) receptor agonist 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: Takeda Pharmaceuticals America, Inc. 2. Camilleri M, Piessevaux H, Yiannakou Y, et al. Dig Dis Sci. 2016;61(8):2357-2372.

©2024 Takeda Pharmaceuticals U.S.A., Inc., Lexington, MA 02421. All rights reserved. 1-877-TAKEDA-7 (1-877-825-3327). MOTEGRITY® and the MOTEGRITY Logo® are registered trademarks of Takeda Pharmaceuticals U.S.A., Inc. TAKEDA and the TAKEDA logo are registered trademarks of Takeda Pharmaceutical Company Limited. US-PRU-0728v2.0 03/24.

All content of this website, including text, images, graphics, sound files, and their arrangement, is copyrighted and owned by Takeda and is protected by international copyright laws. All other intellectual property rights are reserved. The content may not be copied for commercial use or distribution, nor may these objects be downloaded, modified, or posted to other sites. This site is intended solely for US residents and is governed solely by US laws and government regulations. Please see our Legal Notice for more information. While Takeda makes reasonable efforts to include accurate, up-to-date information on this site, Takeda makes no warranties or representations as to its accuracy. Takeda assumes no liability for any errors or omissions in the content of this site. The information on this site is not intended to make a diagnosis or to take the place of talking to a US health care professional.