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Drug Trials Snapshots: MOTEGRITY

Drug Trials Snapshots: MOTEGRITY

HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among sex, race, and age groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.

LIMITATIONS OF THIS SNAPSHOT:
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your health provider about the risks and benefits of a drug. Refer to MOTEGRITY Prescribing Information for complete information.

MOTEGRITY (prucalopride)
moe-teh'-gri-tee
Shire
Approval date: December 14, 2018


DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

MOTEGRITY is used to treat adults with a type of constipation called chronic idiopathic constipation (CIC).

“Idiopathic” means that the cause of the constipation is unknown.

How is this drug used?

MOTEGRITY is a tablet taken one time each day.

What are the benefits of this drug?

More patients who received MOTEGRITY experienced an increase in the number of complete spontaneous bowel movements (CSBMs) to at least 3 bowel movements per week than those who received placebo.

What are the benefits of this drug (results of trials used to assess efficacy)?

Patients who entered the trial had a history of chronic constipation which included having less than 3 bowel movements per week. Efficacy was assessed using information provided by patients on a daily basis in an electronic diary. A responder was defined as a patient with an average of 3 CSBMs per week over the 12-week treatment period.

The table below summarizes efficacy results for the clinical trials based on the primary efficacy endpoint.

Table 2. Efficacy Responder Rates in Placebo Controlled Studies of CIC: Proportion of Patients with an Average Weekly Frequency of ≥3 CSBMs per Week over 12 Weeks of Treatment (ITT Population)

Trial MOTEGRITY 1 or 2 mg Once Daily Placebo Treatment Difference
(95% CI)
p value
N n (%) N n (%)
Trial 1 249 83 (33) 252 26 (10) 23
(16, 30)
p<0.001
Trial 2 177 67 (38) 181 32 (18) 20
(11, 29)
p<0.001
Trial 3 236 46 (19) 240 23 (10) 10
(4, 16)
p=0.002
Trial 4 190 55 (29) 193 25 (13) 16
(8, 24)
p<0.001
Trial 5 214 50 (24) 212 25 (12) 12
(4, 19)
p<0.001
Trial 6 171 43 (25) 169 34 (20) 5
(-4, 14)
p=0.341

N = number of patients per treatment group
n = number of responders
CI=confidence interval
p-value based on a Cochran-Mantel-Haenszel test

MOTEGRITY Prescribing Information

Were there any differences in how well the drug worked in clinical trials among sex, race and age?

  • Sex: MOTEGRITY worked similarly in men and women.
  • Race: MOTEGRITY worked similarly in White and Asian patients. The number of patients in other races was limited; therefore, differences in response among all races could not be determined.
  • Age: MOTEGRITY worked similarly in patients younger than 65 years and 65 years or older.

Were there any differences in how well the drug worked in clinical trials among sex, race, and age groups?

Tables below summarize efficacy results by sex, race and age subgroup for each trial that includes patients who received 2 mg of MOTEGRITY or placebo daily (ITT population).

Table 3. Results for the Primary Efficacy Endpoint by Sex (ITT population)

Trials Men Women
MOTEGRITY
n/N (%)
Placebo
n/N (%)
Difference
(95% CI)
MOTEGRITY
n/N (%)
Placebo
n/N (%)
Difference
(95% CI)
Trial 1 6/22 (27) 2/29 (7) 20 (0, 41) 77/227 (34) 24/223 (11) 23 (16,31)
Trial 2 67/177 (38) 32/181 (18) 20(11,29) NA NA NA
Trial 3 3/25 (12) 2/18 (11) 0.9 (-18,20) 43/211 (20) 21/222 (10) 11 (4,18)
Trial 4 3/16 (19) 4/24 (17) 2 (-22,26) 52/174 (30) 21/169 (12) 17 (9,26)
Trial 5 7/33 (21) 5/23 (22) -0.5 (-22,21) 43/181 (24) 20/189 (11) 13 (6,21)
Trial 6 8/24 (33) 5/25 (20) 13 (-11,38) 35/147 (24) 29/144 (20) 4 (-6,13)

NA=not applicable

Clinical Trial Data

Table 4. Results for the Primary Efficacy Endpoint by Race (ITT population)

Trials White All Other
MOTEGRITY
n/N (%)
Placebo
n/N (%)
Difference
(95% CI)
MOTEGRITY
n/N (%)
Placebo
n/N (%)
Difference
(95% CI)
Trial 1 NA NA NA 83/249 (33) 26/252 (10) 23 (16,30)
Trial 2 67/177 (38) 32/181 (18) 20 (11,29) NA NA NA
Trial 3 45/221 (20) 22/226 (10) 11 (4,17) 1/15 (7) 1/14 (7) -1 (-19,18)
Trial 4 53/171 (31) 22/166 (13) 18 (9,26) 2/19 (11) 3/27 (11) -1 (-19,18)
Trial 5 43/183 (24) 25/197 (13) 11 (3,19) 7/31 (23) 0/15 (0) 23 (8,37)
Trial 6 41/158 (26) 32/158 (20) 6 (-4,15) 2/13 (15) 2/11 (18) -3 (-33,27)

NA=not applicable

Clinical Trial Data

Table 5. Results for the Primary Efficacy Endpoint by Age (ITT population)

Trials Age <65 years Age ≥65 years
MOTEGRITY
n/N (%)
Placebo
n/N (%)
Difference
(95% CI)
MOTEGRITY
n/N (%)
Placebo
n/N (%)
Difference
(95% CI)
Trial 1 83/249 (33) 26/252 (10) 23 (16,30) NA NA NA
Trial 2 39/98 (40) 16/110 (15) 25 (14,37) 28/79 (35) 16/71 (23) 13 (-1,27)
Trial 3 40/209 (19) 20/216 (9) 10 (3,17) 6/27 (22) 3/24 (13) 10 (-11,30)
Trial 4 49/165 (30) 20/165 (12) 18 (9,26) 6/25 (24) 5/28 (18) 6 (-16,29)
Trial 5 42/180 (23) 23/189 (12) 11 (3,19) 8/34 (24) 2/23 (9) 15 (-3,33)
Trial 6 36/141 (26) 30/138 (22) 4 (-6,14) 7/30 (23) 4/31 (13) 10 (-1,30)

NA=not applicable

Clinical Trial Data

What are the possible side effects?

MOTEGRITY may cause suicidal thoughts and behavior.

The most common side effects of MOTEGRITY are headache, stomach pain, nausea, diarrhea, stomach distention, dizziness, vomiting, gassiness, and fatigue.

What are the possible side effects?

The table below summarizes adverse reactions that occurred in combined six clinical trials.

Table 6: Common Adverse Reactions* in Six Double-Blind Placebo-Controlled Trials of CIC of at least 12 Weeks Duration

Adverse Reaction MOTEGRITY
2 mg
N=1251†
%
Placebo
N=1279
%
Headache 19 9
Abdominal pain 16 11
Nausea 14 7
Diarrhea 13 5
Abdominal distension 5 4
Dizziness 4 2
Vomiting 3 2
Flatulence 3 2
Fatigue 2 1

*Reported in ≥2% of patients receiving MOTEGRITY and a rate higher than patients receiving placebo.
Includes 93 patients who started on MOTEGRITY 1 mg and increased to MOTEGRITY 2 mg.
ǂ Includes abdominal pain, upper abdominal pain, lower abdominal pain, abdominal tenderness, abdominal discomfort, and epigastric discomfort.

MOTEGRITY Prescribing Information

Were there any differences in side effects among sex, race and age?

  • Sex: The occurrence of side effects was similar in men and women.
  • Race: The occurrence of side effects was similar in White and Asian patients. The number of patients in other races was limited; therefore, differences in side effects among all races could not be determined.
  • Age: The occurrence of side effects was similar between patients younger than 65 years and 65 years or older.

Were there any differences in side effects of the clinical trials among sex, race, and age groups?

The table below summarizes subgroups of patients who reported any adverse event during clinical trials.

Table 7. Subgroup Analysis of Treatment Emergent AEs - (ITT population)

Any TEAE MOTEGRITY 2 mg
(N=1237)
Placebo
(N=1247)
Overall, n (%) 782 (59) 668 (54)
Sex, n (%)
Men 140 (47) 116 (37)
Women 642 (69) 552 (58)
Race, n (%)
White 596 (64) 539 (57)
Asian 135 (56) 85 (36)
Black or African American 29 (63) 20 (63)
Age, n (%)
<65 years 680 (65) 578 (54)
≥65 years 102 (52) 90 (51)

Clinical Trial Data

WHO WAS IN THE CLINICAL TRIALS?

Who participated in the clinical trials?

The FDA approved MOTEGRITY based on evidence from six clinical trials of 2484 patients with CIC. The trials were conducted at 286 sites in the USA, Canada, Asia, Europe and Australia.

The figure below summarizes how many men and women were in the clinical trials.

Figure 1. Baseline Demographics by Sex

Pie chart summarizing how many men and women were in the clinical trials. In total, 597 men (24%) and 1887 women (76%) participated in the clinical trials.

Clinical Trial Data

Figure 2 and Table 1 below summarize the percentage of patients by race in the clinical trials.

Figure 2. Baseline Demographics by Race

Pie chart summarizing the percentage of patients by race in the clinical trials. In total, 1876 Whites (76%), 78 Blacks (3%), 478 Asians (19%), and 52 Other (2%), participated in the clinical trials.

Clinical Trial Data

Table 1. Baseline Demographics by Race

Race Number of Patients Percentage
White 1876 76
Black or African American 78 3
Asian 478 19
Other 34 1
Missing 18 1

Clinical Trial Data

Figure 3 summarizes the percentage of patients by age enrolled in the clinical trials.

Figure 3. Baseline Demographics by Age

Pie chart summarizing how many individuals of certain age groups were  in the  clinical trials.  In total, 2110 participants were below 65 years old (85%) and 374 participants were 65 and older (15%).

Clinical Trial Data

Who participated in the trials?

The table below summarizes demographics of patients in the clinical trials.

Table 8. Baseline Demographics of Participants in the Clinical Trials (ITT population)

Subgroup MOTEGRITY 2 mg
N=1237
Placebo
N=1247
TOTAL
 (N=2484)
Sex, n (%)
Men 297 (24) 300 (24) 597 (24)
Women 940 (76) 947 (76) 1887 (76)
Race, n (%)
White 925 (75) 951 (76) 1876 (76)
Asian 241 (19) 237 (19) 478 (19)
Black or African American 46 (4) 32 (3) 78 (3)
Other 16 (1) 18 (1) 34 (1)
Missing 9 (1) 9 (1) 18 (1)
Age Group, n (%)
<65 years 1041 (84) 1069 (86) 2110 (85)
≥65 years 196 (16) 178 (14) 374 (15)
Ethnicity, n (%)
Incomplete *
Geographic Region
US 404 (33) 405 (33) 809 (33)
All Other 833 (67) 842 (67) 1675 (67)

* because of local regulations and old data

Clinical Trial Data

How were the trials designed?

The benefit and side effects of MOTEGRITY were evaluated in six clinical trials (Trial 1/ NCT01116206, Trial 2/ NCT01147926, Trial 3/ NCT00488137, Trial 4/ NCT00483886, Trial 5/ NCT00485940 and Trial 6/ NCT01424228) of 2484 patients with CIC. In all the six trials, patients received treatment with either MOTEGRITY or placebo once daily for at least 12 weeks. Neither the patients nor the health care providers knew which treatment was being given until after the trials were completed.

Based on the information from their electronic diaries, patients were evaluated for improvement in CSBMs over 12 weeks of treatment.

How were the trials designed?

The efficacy and safety of MOTEGRITY for the management of symptoms of CIC was established in six double blind, placebo-controlled, randomized, multicenter clinical trials of at least 12-week duration. Adult patients, 18-95 years old, had to have less than 3 spontaneous bowel movements (SBMs) per week specific constipation symptoms for at least 3 months prior to the screening visit, with symptom onset for at least 6 months prior to screening.

A responder was defined as a patient with an average of 3 CSBMs per week over the 12-week treatment period.

GLOSSARY

CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.

PRESCRIBING INFORMATION

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